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637 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Ongentys (opicapone) / Ono Pharma, Neurocrine, BIAL
2020-001175-32: Clinical study to evaluate the effect of opicapone 50 mg in the pain associated to Parkinson’s disease.

Ongoing
4
176
Europe
Ongentys, [BIA 9-1067], Capsule, hard, Ongentys
Bial - Portela & Ca, S.A., BIAL-Portela & Ca, S.A., Bial - Portela & Ca, S.A.
Parkinson's disease patients with wearing-off motor fluctuations andassociated pain., Parkinson's disease result in loss of special nerve cells in the brain. This affects movement, cause tremor and stiffness., Diseases [C] - Nervous System Diseases [C10]
 
 
2020-002754-24: Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. Estudio clínico en pacientes con EP temprana para investigar el efecto de Opicapone 50 mg o Levodopa 100 mg en el tratamiento de las fluctuaciones motoras.

Ongoing
4
100
Europe
Capsule, hard, Tablet, Ongentys 50 mg hard capsules, Madopar 125 mg T, tablets, SINEMET 100 mg + 25 mg tablets
Bial - Portela & Ca, S.A., Bial - Portela & Ca, S.A.
Parkinson's Disease (PD) Enfermedad de Parkinson (EP), Parkinson's Disease (PD) Enfermedad de Parkinson (EP), Diseases [C] - Nervous System Diseases [C10]
 
 
NCT04821687: A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD

Completed
4
169
RoW
Ongentys 50mg, Madopar Tab. 125 or Perkin Tab. 25-100mg
SK Chemicals Co., Ltd.
Parkinson Disease
08/22
08/22
OCEAN, NCT04986982 / 2020-001175-32: OpiCapone Effect on Motor Fluctuations and pAiN

Completed
4
144
Europe
Opicapone 50 mg, BIA 9-1067, Placebo
Bial - Portela C S.A., Bial - Portela & Ca, S.A.
Parkinson Disease
02/24
02/24
2020-001176-15: Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease.

Not yet recruiting
4
30
Europe
Ongentys 50 mg hard capsules, Capsule, Ongentys
Bial - Portela & Ca, S.A., Bial - Portela & Ca, S.A.
Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders., Parkinson's disease patients with associated movement and sleep disorders., Diseases [C] - Nervous System Diseases [C10]
 
 
OASIS, NCT04986995: OpicApone Sleep dISorder

Completed
4
22
Europe
Opicapone, BIA 9-1067
Bial - Portela C S.A.
Parkinson Disease
03/23
03/23
ADOPTION, NCT04990284 / 2020-002754-24: eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.

Completed
4
106
Europe
Opicapone, BIA 9-1067, L-DOPA/DDCI, Levodopa
Bial - Portela C S.A., Bial - Portela & Ca, S.A.
Parkinson Disease
04/23
04/23
2020-005011-52: Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study

Not yet recruiting
3
324
RoW, Europe
Opicapone, BIA 9-1067, Capsule, hard, Ongentys
BIAL – Portela & Cª, S.A., BIAL-Portela & Ca, S.A., BIAL – Portela & Cª, S.A.,
Early Idiopathic Parkinson’s disease, Parkinson’s disease in its early stage, Diseases [C] - Nervous System Diseases [C10]
 
 
EPSILON, NCT04978597: Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe ( Study)

Completed
3
410
Europe
Opicapone 50 mg, Placebo
Bial - Portela C S.A.
Parkinson
01/23
01/24
ChiCTR2300069899: A multicenter, randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of Opicapone in primary Parkinson's disease patients with fluctuating end-of-life motor symptoms after treatment with levodopa/dopamine decarboxylase inhibitors

Not yet recruiting
3
250
 
placebo ;Opicapone 25mg ;Opicapone 50 mg
Ruijin Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Fosun Pharmaceutical (Group) Co., Ltd, Sponsor
Idiopathic Parkinson's disease
 
 
OPAILEC, NCT06432309: Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease

Completed
N/A
22
Europe
Opicapone 50 mg, OPC, Duodopa, Levodopa/carbidopa intestinal gel (LCIG)
University Hospital of Ferrara
Parkinson Disease, Effect of Drug
12/23
04/24
Nerlynx (neratinib) / Puma
ChiCTR2500097583: A multi-center retrospective study of neratinib as extended adjuvant therapy to describe patient characteristics, treatment patterns, safety, and effectiveness in HER2-positive early breast cancer patients in China

Recruiting
4
500
 
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Pierre Fabre (Shanghai) Medical Co.,Ltd., Pierre Fabre (Shanghai) Medical Co.,Ltd.
Breast Cancer
 
 
NCT05760612: A Clinical Study on Hormone Receptor Positive HER2 Positive Breast Cancer of RCB1-2 After Neoadjuvant Treatment with Trastuzumab Combined with Parezumab

Recruiting
3
300
RoW
Trastuzumab and nelatinib, Trastuzumab and Parstuzumab
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Early-stage Breast Cancer, HER2-positive Breast Cancer, Adjuvant Treatment After Trastuzumab, RCB Classification 1-2, Neratini
02/28
11/28
SAFIR-ABC10, NCT05615818: Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting
3
800
Europe
Futibatinib, Ivosidenib, Tibsovo, Zanidatamab, Trastuzumab, Zercepac, Neratinib, Nerlynx, Encorafenib, Braftovi, Binimetinib, Mektovi, Niraparib, Zejula, Cisplatin, Gemcitabine
UNICANCER, Cancer Research UK & UCL Cancer Trials Centre, Belgian Group of Digestive Oncology, National Cancer Institute, France, Cancer Research UK, Taiho Oncology, Inc., Servier, Zymeworks BC Inc., Accord Healthcare, Inc., Pierre Fabre Medicament
Biliary Tract Neoplasms
06/27
06/28
plasmaMATCH, NCT03182634: The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices () Trial

Checkmark Results from cohort B of plasmaMATCH trial in combination with fulvestrant for advanced breast cancer at SABCS 2019
Dec 2019 - Dec 2019: Results from cohort B of plasmaMATCH trial in combination with fulvestrant for advanced breast cancer at SABCS 2019
Recruiting
2a
1150
Europe
Fulvestrant, Neratinib, AZD5363, Olaparib, AZD6738
Institute of Cancer Research, United Kingdom, Royal Marsden NHS Foundation Trust
Advanced Breast Cancer
11/22
11/23
2005-003098-26: Phase 2 Study of HKI-272 in Subjects with Advanced Breast Cancer

Ongoing
2
45
Europe
HKI-272,
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Breast cancer is the most frequently diagnosed malignancy and the second most common cause of cancer related deaths in women. HER2 is a member of the epidermal growth factor receptor (EGFR) family that includes EGFR/HER1, HER2, HER3 and HER4, all being receptor tyrosine-protein kinases. The oncogenic role of HER2 has been extensively documented in breast cancer, where it is overexpressed in 25% to 30% of breast cancers.
 
 
2013-004391-35: A study before surgery evaluating Regimens with Weekly Paclitaxel plus Neratinib or Trastuzumab or Neratinib and Trastuzumab Followed by Doxorubicin and Cyclophosphamide with Postoperative Trastuzumab in Women with Locally Advanced HER2-Positive Breast Cancer. Studio clinico precedente all\'intervento chirurgico per valutare i regimi di Paclitaxel settimanale più Neratinib o Trastuzumab o Neratinib e Trastuzumab seguito da Doxorubicina e Ciclofosfamide con Trastuzumab postoperatorio in donne con tumore alla mammella HER2-positivo localmente avanzato.

Ongoing
2
33
Europe
Neratinib, PB-272; HKI-272, Herceptin, Herceptin
Puma Biotechnology Inc., Puma Biotechnology, Inc
Locally advanced HER2-positive breast cancer tumore alla mammella HER2-positivo localmente avanzato
 
 
2019-001896-35: A Clinical Study to Investigate Colon Pathology in Patients With Breast Cancer And HER2 Overexpression When Treated With Neratinib Um estudo clínico para investigar a patologia do cólon em doentes com cancro da mama e sobre-expressão de HER2 quando tratados com Neratinib

Not yet recruiting
2
5
Europe
Neratinib, PB-272; HKI-272, Film-coated tablet
Puma Biotechnology, Inc, Puma Biotechnology, Inc.
HER2 amplified (HER2+) stage 1 through stage 4 primary adenocarcinoma of the breast Adenocarcinoma da mama primário em estadio 1 até ao estadio 4 com amplificação do HER2 (HER2+), Breast Cancer with HER2 gene overexpression Cancro da mama com sobre-expressão do gene HER2, Diseases [C] - Cancer [C04]
 
 
2019-000710-11: Clinical study with Neratinib in Metastatic breast cancer Estudio clínico con Neratinib en cancer de mama metastásico

Not yet recruiting
2
62
Europe
Neratinib, PB-272; HKI-272, Film-coated tablet, Nerlynx
SOLTI, PUMA BIOTECHNOLOGY INC
Pre and post-menopausal women and men with locally advanced or metastatic HR+/HER2-negative endocrine resistant breast cancer Hombres y Mujeres pre y posmenopáusicas con cáncer de mama localmente avanzado o metastásico RH+/HER2-negativo resistente al tratamiento endocrino, Breast cancer Cancer de mama, Diseases [C] - Cancer [C04]
 
 
FACT-2, NCT03812393: Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast

Hourglass Oct 2021 - Mar 2022 : Interim data from FACT-2 trial for early stage TNBC-negative that respond to pan-HER drugs
Active, not recruiting
2
27
US
Neratinib, Live Cell HER2 signaling Transduction Analysis (CELx)
West Cancer Center, Celcuity Inc, Puma Biotechnology, Inc.
Triple Negative Breast Cancer, Early-stage Breast Cancer, HER2-positive Breast Cancer
12/24
12/24
NCT03289039: Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer

Terminated
2
21
US
Neratinib, Nerlynx, Fulvestrant, Faslodex
Dana-Farber Cancer Institute, Puma Biotechnology, Inc.
Breast Cancer
07/21
07/21
NSABP FC-11, NCT03457896: Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status

Active, not recruiting
2
35
US
Trastuzumab, Cetuximab, Neratinib, Nerlynx, Guardant360 Diagnostic Test
NSABP Foundation Inc, Puma Biotechnology, Inc.
Metastatic Colorectal Cancer
09/21
09/22
2020-000824-21: An open label phase II study to evaluate neratinib for treatment and prevention of subsequent CNS event(s) in patients with brain metastasis of advanced HER2 positive breast cancer

Not yet recruiting
2
125
Europe
neratinib, capecitabine, trasntuzumab emtansine, paclitaxel, vinorelbine, herceptin, Film-coated tablet, Powder and solvent for concentrate for solution for infusion, Concentrate and solvent for solution for injection, Concentrate for solution for injection, Powder for concentrate for solution for infusion
Institut Jules Bordet, PUMA
HER2 positive breast cancer patients with brain metastases, HER2 positive breast cancer patients with brain metastases, Diseases [C] - Cancer [C04]
 
 
2019-001559-38: Phase II study to evaluate diarrhoea discontinuations at 3 cycles in patients with early-stage HER2 positive, hormone receptor positive breast cancer treated with neratinib plus loperamide versus neratinib dose escalation plus loperamide administered as needed versus neratinib plus loperamide plus colesevelam Estudio fase II para evaluar la incidencia de abandono debida a diarrea en 3 ciclos de tratamiento en pacientes con cáncer de mama estadio temprano HER2 positivo, receptor hormonal positivo tratados con neratinib más loperamida frente a neratinib con escalada de dosis más loperamida administrada solamente según necesidad frente a neratinib más loperamida más colesevelam

Not yet recruiting
2
315
Europe
Neratinib, Loperamide, Colesevelam, PB-272; HKI-272, Film-coated tablet, Capsule, hard, Nerlynx, Sindiar, Cholestagel
GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama), PUMA BIOTECHNOLOGY, INC
HER2+, HR+ Early stage Breast Cancer Cáncer de Mama Precoz HER2+, RH+, HER2 positive, Hormone Receptor positive Early-stage Breast Cancer Cáncer de mama precoz HER2 positivo, receptor hormonal positivo, Diseases [C] - Cancer [C04]
 
 
TBCRC 022, NCT01494662: HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

Hourglass Jan 2022 - Jun 2022 : Data from trial in combination with neratinib for HER2-positive breast cancer with brain metastases
Hourglass Jul 2021 - Dec 2021 : Data from cohort 4 of P2 trial in combination with kadcyla for HER2-positive breast cancer
Checkmark Pooled data from NALA, NEfERT-T and TBCRC 022 trials for HER2-positive breast cancer at SABCS 2019
Dec 2019 - Dec 2019: Pooled data from NALA, NEfERT-T and TBCRC 022 trials for HER2-positive breast cancer at SABCS 2019
Checkmark In HER2+ metastatic breast cancer with brain metastases
More
Active, not recruiting
2
140
US
HKI-272, Neratinib, Surgical Resection, Biopsy, Capecitabine, Xeloda, Ado-Trastuzumab Emtansine, T-DM1
Dana-Farber Cancer Institute, Translational Breast Cancer Research Consortium, Puma Biotechnology, Inc.
Breast Cancer
02/23
12/25
2022-002582-15: Phase II Study mit Neratinib and Trastuzumab with or without Vinorelbine per mouth in patients with pretreated metastatic Her2- positive breast cancer Phase II Study mit Neratinib and Trastuzumab with or without Vinorelbine per mouth in patients with pretreated metastatic Her2- positive breast cancer

Ongoing
2
65
Europe
Neratinib, Navelbine, PRD7433212, L01CA04, Film-coated tablet, Capsule, Nerlynx, Navelbine
Medical University Graz, Pierre Fabre
Patients with histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive metastatic breast cancer (mBC) pretreated with trastuzumab, pertuzumab, and/or trastuzumab emtansine (T-DM1) and/ or T-DXd and/or tucatinib Patientinnen mit histologisch bestätigten Human Epidermen Wachstumsfaktor Rezeptor 2 (Her2) positiven metasierten Brustkrebserkrankung, vorbehandelt mit Trastuzumab, Pertuzumab und/ oder Trastuzumab Emtansine (T-DM1) und/ oder Trastuzumab Deruxtecan und/ oder Tucatinib, Patients with Her2 positive metastatic breast cancer who were pretreted with 2-4 lines of previous treatment Patientinnen mit Her2 positiven metastasierten Brustkrebserkrankung die mit 2-4 Therapielinien vorbehandelt wurden, Diseases [C] - Cancer [C04]
 
 
NCT04886531: Trial of Pre-operative Neratinib and Endocrine Therapy with Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

Recruiting
2
30
US
Neratinib, Nerlynx, Letrozole (L) or Anastrozole (A), Femara, Arimidex, Trastuzumab, Herceptin
Ruth O'Regan, Puma Biotechnology, Inc., University of Rochester
Breast Cancer, HER2-positive Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
09/25
10/25
NCT05512182: Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression

Withdrawn
2
50
RoW
Chemotherapy
Yonsei University
Recurrent/Advanced Gastric Cancer
10/23
10/23
KCSG AL20-17, NCT06083662: Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers

Completed
2
42
RoW
Neratinib Maleate, Herzuma
Korea University Guro Hospital, Korean Cancer Study Group
Metastatic Cancer, HER2 Gene Mutation
11/23
12/24
DIANER, NCT05252988: Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib

Active, not recruiting
2
177
Europe
Neratinib, Nerlynx, Loperamide, Sindiar, Colesevelam, Cholestagel
Spanish Breast Cancer Research Group, Puma Biotechnology, Inc., Pierre Fabre Laboratories
Early-stage Breast Cancer, HER2 Positive Breast Cancer, Hormone Receptor Positive
10/24
01/30
NCT05154396: Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

Not yet recruiting
2
60
NA
Neratinib, Loperamide prophylaxis
Chinese Academy of Medical Sciences
HER2-positive Breast Cancer
12/23
12/24
CVL009-2002, NCT06374888: Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases

Not yet recruiting
2
28
NA
Neratinib maleate in combination with capecitabine
Convalife (Shanghai) Co., Ltd.
Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis
09/26
07/27
NCT06126276: Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

Recruiting
2
70
US
Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Echocardiography Test, EC, Echocardiography, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Neratinib Maleate, 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1), HKI-272 Maleate, NERATINIB MALEATE ANHYDROUS, Nerlynx, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, PD0332991
National Cancer Institute (NCI)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm
02/27
02/27
HER2-Signal, NCT04901299: Fulvestrant + Neratinib In Breast Cancer

Withdrawn
2
25
US
NERATINIB, Nerlynx, FULVESTRANT, Faslodex
Massachusetts General Hospital, Celcuity, Inc., Puma Biotechnology, Inc.
Stage IV (Metastatic) Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer, HER2-negative Breast Cancer, Invasive Breast Cancer
07/24
07/25
CVL009-C2001, NCT06519110: Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations

Not yet recruiting
2
60
NA
Neratinib tablets, Neratinib
Convalife (Shanghai) Co., Ltd.
Advanced Solid Tumor
02/26
04/26
NCT04965064: Trial of Neratinib Plus Capecitabine in Subjects with HER2-Negative Metastatic Breast Cancer with Brain Metastases and Abnormally Active HER2 Signaling

Recruiting
2
22
US
Capecitabine and Neratinib.
University of Rochester
Breast Cancer
09/26
09/27
NCT04760431: TKIs vs. Pertuzumab in HER2+ Breast Cancer Patients With Active Brain Metastases (HER2BRAIN)

Not yet recruiting
2
120
RoW
Trastuzumab, Herceptin, Taxanes, Docetaxel, Paclitaxel, Paclitaxel (Albumin bound), Paclitaxel Liposome, Pertuzumab, Perjeta, Tyrosine kinase inhibitor, Pyrotinib, Neratinib, Tucatinib
Second Affiliated Hospital, School of Medicine, Zhejiang University, Peking University International Hospital, Sun Yat-sen University, Zhejiang University
HER2-positive Breast Cancer, Brain Metastases
09/24
09/25
CVL009-2001, NCT06029816: Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations

Not yet recruiting
2
42
RoW
Neratinib tablets, Epilepsy
Convalife (Shanghai) Co., Ltd.
NSCLC
12/24
12/25
SPRING, NCT06692491: Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

Not yet recruiting
2
200
NA
Albumin-Bound Paclitaxel, Abraxane, Epirubicin, Ellence, Gemcitabine, Gemzar, Vinorelbine, Navelbine, Vumon, Cisplatin, Platinol, Irinotecan, Camptosar, Fluorouracil, Adrucil, 5-FU, Nivolumab, Opdivo, Pembrolizumab, Keytruda, Durvalumab, Imfinzi, Atezolizumab, Tecentriq, Sintilimab, Tyvyt, Tislelizumab, Baizean, Camrelizumab, AiRuiKa, Toripalimab, Tuoyi, Serplulimab, Hansizhuang, Adebrelimab, Abesive, Envafolimab, Epkinly, Osimertinib, Tagrisso, Alectinib, Alecensa, Vemurafenib, Zelboraf, Pamiparib, Balversa, Pyrotinib, Nerlynx, Imatinib, Gleevec, Palbociclib, Ibrance, Savolitinib, Orpathys, Entrectinib, Rozlytrek, Other
Peking University Shenzhen Hospital
Rare Tumour
12/27
12/29
NCT06813079: Using Tumor Models to Determine Treatments

Not yet recruiting
2
25
Canada
Cobimetinib, Ponatinib, Brigatinib, Colchicine, Selinexor, Abemaciclib, Neratinib, Doxorubicin, Etoposide, Ceritinib
University Health Network, Toronto
Pancreatic Ductal Carcinoma, Advanced Cancer, Epithelial Tumor
02/28
02/28
INSIGhT, NCT02977780: INdividualized Screening Trial of Innovative Glioblastoma Therapy

Recruiting
2
460
US
Temozolomide, Temodar, Neratinib, QBS10072S
Patrick Wen, MD, Eli Lilly and Company, Celgene, Puma Biotechnology, Inc., Accelerate Brain Cancer Cure, Quadriga Biosciences, Inc.
Glioblastoma
02/27
04/27
KAN-HER2 MRD, NCT05388149: Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease

Recruiting
2
15
Canada
Neratinib, NERLYNX
University Health Network, Toronto
Breast Cancer, HER2-positive Breast Cancer
07/26
07/26
NCT06109467: Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer

Recruiting
2
36
US
Neratinib, NERLYNX, Trastuzumab, Herceptin, Oxaliplatin, Eloxatin, 5-Fluorouracil + leucovorin, Pembrolizumab, Keytruda
H. Lee Moffitt Cancer Center and Research Institute, Puma Biotechnology, Inc., National Comprehensive Cancer Network
GastroEsophageal Cancer, Gastric Cancer
04/28
04/28
VICC-NCBRE23172, NCT05919108: Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

Recruiting
2
30
US
Endocrine Therapy, Biopsy of breast, Neratinib, Biospecimen Collection, Mammogram, Magnetic Resonance Imaging, Breast Surgery, Ultrasound
Vanderbilt-Ingram Cancer Center, National Cancer Institute (NCI), Puma Biotechnology, Inc.
Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma
04/30
04/31
INTUITT-NF2, NCT04374305: Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis

Active, not recruiting
2
100
US
Brigatinib, Alunbrig, Neratinib, Nerlynx
Scott R. Plotkin, MD, PhD, Takeda, The Children's Tumor Foundation, National Comprehensive Cancer Network
Neurofibromatosis Type 2, Vestibular Schwannoma, Non-vestibular Schwannoma, Meningioma, Ependymoma
12/29
12/30
NCT05564377: Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Recruiting
2
2900
US
Alpelisib, BYL 719, BYL-719, BYL719, Phosphoinositide 3-kinase Inhibitor BYL719, Piqray, VIJOICE, Binimetinib, ARRY 162, ARRY 438162, ARRY-162, ARRY-438162, ARRY162, ARRY438162, MEK 162, MEK-162, MEK162, Mektovi, Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Scan, Bone Scintigraphy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Echocardiography Test, EC, Echocardiography, Fluorouracil, 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757, Fulvestrant, Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780, ICI-182780, ICI182780, ZD 9238, ZD-9238, ZD9238, Ipatasertib, GDC 0068, GDC-0068, GDC0068, RG 7440, RG-7440, RG7440, Leucovorin, Folinic acid, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Mutation Carrier Screening, Neratinib Maleate, 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1), HKI-272 Maleate, NERATINIB MALEATE ANHYDROUS, Nerlynx, Nilotinib Hydrochloride Monohydrate, AMN 107, AMN-107, AMN107, Nilotinib Monohydrochloride Monohydrate, Tasigna, Olaparib, AZD 2281, AZD-2281, AZD2281, KU 0059436, KU-0059436, KU0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281, Oxaliplatin, 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, Elplat, JM 83, JM-83, JM83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, RP54780, SR 96669, SR-96669, SR96669, Paclitaxel, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, PD0332991, Panitumumab, ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, E7.6.3, Human IgG2K Monoclonal Antibody, MoAb ABX-EGF, MoAb E7.6.3, Monoclonal Antibody ABX-EGF, Monoclonal Antibody E7.6.3, Vectibix, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Selumetinib Sulfate, AZD-6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulphate, Koselugo, Selumetinib Sulphate, Sotorasib, AMG 510, AMG-510, AMG510, Lumakras, Lumykras
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable HER2-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm
07/30
07/30
GERTRUDE, NCT05933395: Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Recruiting
2
135
US
Fulvestrant, Neratinib, Alpelisib, Everolimus, Abemaciclib
Dartmouth-Hitchcock Medical Center
Advanced Breast Cancer
10/30
10/31
I-SPY 2, NCT01042379: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Hourglass Jan 2023 - Dec 2023 : From P2 I-SPY 2 trial for invasive breast cancer
Checkmark Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Checkmark Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
Nov 2018 - Nov 2018: Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
More
Recruiting
2
5000
US
Standard Therapy, Paclitaxel (Taxol); Doxorubicin (Adriamycin), AMG 386 with or without Trastuzumab, AMG 386 (Trebananib); (Trastuzumab) Herceptin, AMG 479 (Ganitumab) plus Metformin, Ganitumab, MK-2206 with or without Trastuzumab, (Trastuzumab) Herceptin, AMG 386 and Trastuzumab, AMG 386 (Trebananib); Trastuzumab (Herceptin), T-DM1 and Pertuzumab, T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta), Pertuzumab and Trastuzumab, Pertuzumab (Perjeta); Trastuzumab (Herceptin), Ganetespib, ABT-888, Veliparib, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin), SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, SAR439859, Amcenestrant + Abemaciclib, Amcenestrant (SAR439859), Abemaciclib (Verzenio), Amcenestrant + Letrozole, Amcenestrant (SAR439859), Letrozole (Femara), ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, VOYAGER V1™, VSV-IFNβ-NIS, Datopotamab deruxtecan, Dato-DXd, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel
QuantumLeap Healthcare Collaborative
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
12/30
12/31
2006-006412-29: A Phase 1 / 2 Study of HKI-272 in combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer

Ongoing
1/2
95
Europe
HKI-272, PACLITAXEL 6MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION, Capsule*, Concentrate for solution for infusion, Paclitaxel 6mg/ml Concentrate for Solution for Infusion
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Metastatic breast cancer remains incurable and represents an area of unmet medical need globally. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) activation occurs in breast cancer. This activation contributes to the development and metastatic potential of breast cancer. Dual EGFR/HER2 inhibitors may have activity in the treatment of prior trastuzumab treated HER2 positive metastatic breast cancer.
 
 
2006-003215-52: Estudio de Fase I/II de HKI-272 en combinación con trastuzumab (Herceptin) en sujetos con cáncer de mama avanzadoA Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer.

Ongoing
1/2
12
Europe
HKI-272, Herceptin - Powder for concentrate for solution for infusion - trastuzumab 150 mg, Herceptin - Powder for concentrate for solution for infusion - trastuzumab 150 mg
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Advanced HER2 breast cancer. HER2 is a member of the epidermal growth factor (EGFR) family of receptors involved in cell proliferation, tumorigenesis, and metastasis and abnormally expressed in multiple tumor types. EGFR may also be over-expressed in breast cancer, play a role in tumorigenesis, and also confers a worse prognosis. Coexpression of EGFR family (HER1, 2 and 3) has been associated with a negative synergistic effect on 15-year disease specific survival of breast cancer patients.
 
 
2008-001662-85: Phase 1/2 Randomized, Open-label, Three Arm Study of Neratinib (HKI-272) vs. Neratinib + Capecitabine vs. Lapatinib + Capecitabine, in Subjects with Solid Tumors and ErbB-2 Positive Metastatic or locally advanced Breast Cancer

Ongoing
1/2
40
Europe
neratinib, HKI-272, XELODA 150 mg comprimidos recubiertos con película, TYVERB 250 mg comprimidos recubiertos con película, XELODA 150 mg comprimidos recubiertos con película, TYVERB 250 mg comprimidos recubiertos con película
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Solid tumors (part 1) and metastatic breast cancer (part 2)
 
 
NCT03919292: Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca

Recruiting
1/2
83
US
Neratinib, Nerlynx, Divalproex Sodium, Depakote, Valproate
Virginia Commonwealth University, Puma Biotechnology, Inc.
Solid Tumor, Adult
05/26
05/27
NCT02932280: Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment

Active, not recruiting
1/2
14
Canada, US
Neratinib
Memorial Sloan Kettering Cancer Center, Milton S. Hershey Medical Center, M.D. Anderson Cancer Center, Stanford University, Arkansas Children's Hospital Research Institute, Alberta Children's Hospital, Phoenix Children's Hospital, University of Texas
Solid Tumor, Central Nervous System Tumor, Lymphoma, Leukemia
10/25
10/25
NCT03377387: Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer

Active, not recruiting
1/2
34
US
Capecitabine, Neratinib, EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30
Memorial Sloan Kettering Cancer Center, Puma Biotechnology, Inc.
Breast Cancer
12/26
12/26
NCT03101748: Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer

Terminated
1/2
34
US
Cyclophosphamide, (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Laboratory Biomarker Analysis, Neratinib, (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272, Paclitaxel, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, Pertuzumab, 2C4, 2C4 Antibody, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Perjeta, rhuMAb2C4, RO4368451, Trastuzumab, ABP 980, ALT02, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, c-erb-2 Monoclonal Antibody, HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, Herzuma, Kanjinti, MoAb HER2, Monoclonal Antibody c-erb-2, Monoclonal Antibody HER2, Ogivri, Ontruzant, PF-05280014, rhuMAb HER2, RO0452317, SB3, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar ALT02, trastuzumab biosimilar EG12014, Trastuzumab Biosimilar HLX02, Trastuzumab Biosimilar PF-05280014, Trastuzumab Biosimilar SB3, Trastuzumab Biosimilar SIBP-01, Trastuzumab-anns, Trastuzumab-dkst, Trastuzumab-dttb, Trastuzumab-pkrb, Trastuzumab-qyyp, Trazimera
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Breast Inflammatory Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7
05/25
05/25
NCT05243641: Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

Terminated
1/2
10
US
Neratinib, Capmatinib
M.D. Anderson Cancer Center, Celcuity Inc, Novartis, Puma Biotechnology, Inc.
Metastatic Breast Cancer, Breast Cancer
11/24
11/24
iNNOVATE, NCT04502602: Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer

Active, not recruiting
1
18
US
Neratinib 160 mg, Neratinib 200 mg, Neratinib 240 mg, Niraparib 100 mg, Niraparib 200 mg, Niraparib 300 mg, Niraparib at RP2D, Neratinib at RP2D
Virginia Commonwealth University, Puma Biotechnology, Inc., GlaxoSmithKline
Advanced Solid Tumor, Ovarian Cancer
08/26
05/29
NCI 10495, NCT05372614: Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene

Recruiting
1
30
US
Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Echocardiography Test, EC, Echocardiography, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Neratinib Maleate, 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1), HKI-272 Maleate, NERATINIB MALEATE ANHYDROUS, Nerlynx, Trastuzumab Deruxtecan, DS-8201, DS-8201a, Enhertu, Fam-trastuzumab Deruxtecan-nxki, T-DXd, WHO 10516
National Cancer Institute (NCI)
Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
12/25
12/25
NCT05274048: Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients

Recruiting
1
18
US
Neratinib Pill, Fam-Trastuzumab Deruxtecan-Nxki (TDxD)
Fox Chase Cancer Center, National Comprehensive Cancer Network, Puma Biotechnology, Inc.
Gastric Cancer, Gastrointestinal Cancer, HER2 Gene Mutation
06/25
06/27
NCT06008275: Neratinib in Combination With Ruxolitinib in Patients With mTNBC

Recruiting
1
20
US
Neratinib Oral Tablet, Ruxolitinib Oral Tablet, Jakafi
Baylor Research Institute
Metastatic Triple-Negative Breast Carcinoma, Breast Cancer
06/26
12/26
SMMART, NCT03878524: Serial Measurements of Molecular and Architectural Responses to Therapy () PRIME Trial

Terminated
1
2
US
Abemaciclib, LY-2835219, LY2835219, Verzenio, Abiraterone, CB 7598, Afatinib, BIBW 2992, BIBW2992, Bevacizumab, ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev, Anti-VEGF Monoclonal Antibody SIBP04, SIBP 04, SIBP-04, SIBP04, Bicalutamide, Casodex, Cosudex, ICI 176,334, ICI 176334, Biospecimen Collection, Biological Sample Collection, Specimen Collection, Bortezomib, [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade, Cabazitaxel, Jevtana, RPR-116258A, Taxoid XRP6258, XRP-6258, Cabozantinib, Capecitabine, Ro 09-1978/000, Xeloda, Carboplatin, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo, Celecoxib, Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177, Cobimetinib, Cotellic, GDC-0973, MEK Inhibitor GDC-0973, XL518, 934660-93-2, Copanlisib, BAY 80-6946, PI3K Inhibitor BAY 80-6946, Dabrafenib, BRAF Inhibitor GSK2118436, GSK-2118436, GSK-2118436A, GSK2118436, Dacomitinib, EGFR Inhibitor PF-00299804, PF-00299804, PF-00299804-03, PF-299804, Vizimpro, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, 1297538-32-9, Dasatinib, BMS-354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Durvalumab, Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736, 1428935-60-7, Enasidenib, AG-221, CC-90007 Free Base, Entrectinib, Rozlytrek, RXDX 101, RXDX-101, RXDX101, Enzalutamide, ASP9785, MDV3100, Xtandi, Erlotinib, Everolimus, 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress, Fluorouracil, 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757, Idelalisib, CAL-101, GS 1101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig, Imatinib, Ipilimumab, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy, Lenvatinib, E7080, ER-203492-00, Multi-Kinase Inhibitor E7080, Leucovorin, Folinic acid, Lorlatinib, 2H-4,8-Methenopyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-, Lorbrena, PF-06463922, Losartan, Nab-paclitaxel, ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel, Neratinib, (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272, Nivolumab, BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo, Olaparib, AZD 2281, AZD-2281, AZD2281, KU-0059436, Lynparza, PARP Inhibitor AZD2281, Oxaliplatin, 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, Panobinostat, Faridak, LBH589, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Pertuzumab, 2C4, 2C4 Antibody, HS627, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Perjeta, Pertuzumab Biosimilar HS627, rhuMAb2C4, RO4368451, HLX11, Ponatinib, AP-24534, AP24534, Quality-of-Life Assessment, Quality of Life Assessment, Regorafenib, BAY 73-4506, REGORAFENIB ANHYDROUS, Stivarga, Ruxolitinib, INCB-18424, INCB18424, Jakafi, Oral JAK Inhibitor INCB18424, Sirolimus, AY 22989, RAPA, Rapamune, Rapamycin, SILA 9268A, WY-090217, Sorafenib, BA4 43 9006, BAY 43-9006, Bay-439006, Sunitinib, Trametinib, GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Trastuzumab Emtansine, Ado Trastuzumab Emtansine, ADO-Trastuzumab Emtansine, Kadcyla, PRO132365, RO5304020, T-DM1, Trastuzumab-DM1, Trastuzumab-MCC-DM1, Trastuzumab-MCC-DM1 Antibody-Drug Conjugate, Trastuzumab-MCC-DM1 Immunoconjugate, Tretinoin, 2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-, Aberel, Airol, Aknoten, all trans-Retinoic acid, All-trans Retinoic Acid, All-trans Vitamin A Acid, all-trans-Retinoic acid, all-trans-Vitamin A acid, ATRA, Avita, beta-Retinoic Acid, Cordes Vas, Dermairol, Epi-Aberel, Eudyna, Renova, Retin-A, Retin-A MICRO, Retin-A-Micro, Retinoic Acid, Retisol-A, Ro 5488, Stieva-A, Stieva-A Forte, Trans Retinoic Acid, Trans Vitamin A Acid, trans-Retinoic Acid, Tretinoinum, Vesanoid, Vitamin A Acid, Vitamin A acid, all-trans-, Vitinoin, Vemurafenib, BRAF (V600E) kinase inhibitor RO5185426, BRAF(V600E) Kinase Inhibitor RO5185426, PLX-4032, PLX4032, RG 7204, RG7204, RO 5185426, Zelboraf, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto, Vismodegib, Erivedge, GDC-0449, Hedgehog Antagonist GDC-0449, Vorinostat, L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
OHSU Knight Cancer Institute, Oregon Health and Science University
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Anatomic Stage IV Breast Cancer AJCC v8, Anemia, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Castration-Resistant Prostate Carcinoma, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Pancreatic Adenocarcinoma, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Primary Myelofibrosis, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Hematologic Malignancy, Recurrent Hodgkin Lymphoma, Recurrent Myelodysplastic Syndrome, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Chronic Myelomonocytic Leukemia, Refractory Hematologic Malignancy, Refractory Hodgkin Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Myelodysplastic Syndrome, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Refractory Primary Myelofibrosis, Refractory Small Lymphocytic Lymphoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma
12/20
12/20
NCI-2018-01218, NCT03065387: Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation

Active, not recruiting
1
93
US
Everolimus, 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress, Neratinib, (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, Trametinib, GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Mekinist
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm, EGFR Gene Amplification, EGFR Gene Mutation, ERBB2 Gene Amplification, ERBB2 Gene Mutation, ERBB3 Gene Mutation, ERBB4 Gene Mutation, KRAS Gene Mutation, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
10/25
10/25
NCT01956253: Single Subject Neratinib in Bladder Cancer (NRR)

No Longer Available
N/A
US
Neratinib
UNC Lineberger Comprehensive Cancer Center
Bladder Cancer
09/13
06/14
NeraHER2, NCT06693024: Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

Recruiting
N/A
2806
RoW
neratinib
Shu Wang
HER2-positive Breast Cancer
12/31
12/31
ChiCTR2200055875: Effects of natural plant extracts (targeted inhibitors: PD0325901/AZ-628/ Neratinib/Selumetinib/ VX-11E) on chondrocyte and osteoclast microenvironment in osteoarthritis and its mechanism

Recruiting
N/A
100
 
No intervention ;No intervention
Taizhou Hospital of Zhejiang Province; Taizhou Hospital of Zhejiang Province, Zhejiang Provincial Natural Science Foundation Of China (GF18H060033), Taizhou Key Disciplines Foundation of China (ZDXK202010150001), Taizhou Key Disciplines Group Foundation of China (ZDXK202010150027), Academician Dai Kerong Workstation Research Fund Project (RCZX201907240001)
Osteoarthritis, osteoporosis
 
 
ELEANOR, NCT04388384: Real-life Pan-HER-blockade With Neratinib

Active, not recruiting
N/A
304
Europe
Neratinib, Nerlynx
Pierre Fabre Pharma GmbH, iOMEDICO AG, Pierre Fabre Pharma Austria, Pierre Fabre Pharma AG
Breast Neoplasm
01/25
01/25
NCT06892093: Probiotics for Prevention of Pyrotinib/Neratinib-Induced Diarrhea in Breast Cancer Patients

Not yet recruiting
N/A
308
RoW
Probiotics, Placebo
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Jiangnan University
HER2-positive Breast Cancer, Diarrhea Caused by Drug, Neratinib, Pyrotinib
06/27
12/27
NCT07019272: Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study

Not yet recruiting
N/A
170
NA
Neratinib (HKI-272)
Hebei Medical University Fourth Hospital
HER2-positive Breast Cancer
07/29
10/30
ChiCTR2300074308: Efficacy and safety of Disitamab Vedotin plus pyrotinib or naratinib in HER2-positive breast cancer patients with brain metastasis

Not yet recruiting
N/A
20
 
Disitamab Vedotin with pyrotinib or neratinib
Xi'an International Medical Center Hospital; Xi'an International Medical Center Hospital, Hangzhou Oriental Clinical Oncology Research Center
Breast cancer
 
 
NEAR, NCT05599334: A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib

Recruiting
N/A
130
Europe
Pierre Fabre Medicament, Iqvia Pty Ltd
Breast Cancer, Adjuvant Therapy, HER2-positive Breast Cancer
02/23
02/23
NER-Tree, NCT05491057: Treatment Patterns of Neratinib in HER2+ EBC in China

Not yet recruiting
N/A
500
RoW
Neratinib
Pierre Fabre Medicament
Breast Cancer
12/25
06/26
Fablyn (lasofoxifene) / Sermonix
ELAINE 3, NCT05696626: Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Recruiting
3
500
Europe, Canada, US, RoW
Lasofoxifene in combination with abemaciclib, Fulvestrant in combination with abemaciclib
Sermonix Pharmaceuticals Inc.
Metastatic Breast Cancer
04/27
04/28
ChiCTR2400090280: An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2− Breast Cancer with an ESR1 Mutation

Not yet recruiting
3
400
 
Oral lasofoxifene tartrate+ abemaciclib; Oral abemaciclib, intramuscular fluvestrant
Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center, Shanghai Henlius Biotech Co., Ltd
Breast Cancer
 
 
2020-005936-31: An Open-label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer with an estrogen receptor mutation

Not yet recruiting
2
100
Europe
Lasofoxifene, Tablet, Solution for injection, FASLODEX
Sermonix Pharmaceuticals, Sermonix Pharmaceuticals
Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation, Locally Advanced or Metastatic Breast Cancer with an estrogen receptor mutation, Diseases [C] - Cancer [C04]
 
 
ELAINEII, NCT04432454: Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Completed
2
29
US
Lasofoxifene and abemaciclib (VERZENIO (R)).
Sermonix Pharmaceuticals Inc.
Metastatic Breast Cancer
01/25
01/25
ELAINE 1, NCT03781063 / 2020-005936-31: Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Active, not recruiting
2
100
Canada, US, RoW
Lasofoxifene, Fulvestrant
Sermonix Pharmaceuticals Inc., Linical Accelovance Group
Locally Advanced or Metastatic Breast Cancer
12/24
12/24
NCT06197568: Open-Label Study of Vaginal AZU-101 in Postmenopausal Women

Not yet recruiting
1/2
35
NA
Lasofoxifene Tartrate (AZU-101), AZU-101
Azure Biotech Inc.
Postmenopausal Symptoms
09/24
12/24
Ibsrela (tenapanor) / Ardelyx
NCT06481150: A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Recruiting
4
10
US
Tenapanor, XPHOZAH, IBSRELA, Placebo
University of Texas Southwestern Medical Center, National Center for Advancing Translational Sciences (NCATS)
Hyperoxaluria
06/25
08/25
NCT05995899: Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

Recruiting
4
30
US
Tenapanor
Kyle Staller, MD, MPH, Ardelyx
IBS, IBS - Irritable Bowel Syndrome
11/26
11/26
ChiCTR2300068249: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study for the Efficacy and Safety of Tenapanor Tablets in the Treatment of Hyperphosphatemia in Patients with End-Stage Renal Disease on Hemodialysis (ESRD-HD)

Completed
3
160
 
oral ;oral
Peking University People's Hospital; Fosun Pharmaceutical Development Co, Ltd., Sponsor
Hyperphosphatemia in ESRD-HD patients
 
 
NCT04771780: Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Completed
3
213
Japan
KHK7791
Kyowa Kirin Co., Ltd.
Hyperphosphatemia
06/22
06/22
NCT05643534: Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Recruiting
3
180
US
Tenapanor 50 MG, Tenapanor 25 mg bid, Placebo
Ardelyx
Irritable Bowel Syndrome With Constipation (IBS-C)
12/25
12/25
NCT06810167: Assessing Tenapanor as a Treatment of CF-related Constipation.

Recruiting
3
25
US
Tenapanor
Massachusetts General Hospital, Ardelyx
Cystic Fibrosis, Constipation
02/26
06/27
NCT05905926: Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Enrolling by invitation
3
150
US
Tenapanor, Ibsrela
Ardelyx
Irritable Bowel Syndrome With Constipation (IBS-C)
07/31
10/31
2014-005086-70: N/A non disponibile

Not yet recruiting
2
130
Europe
FBS0701 capsule, FBS0701 CAPSULE, FBS0701/SSP004184, FBS0701, FBS0701 /SSP004184, Capsule, hard
SHIRE DEVELOPMENT LLC AND INTERNATIONAL AFFILIATES, Shire Development LLC and International Affiliates
n patients with B-thalassemia, regular transfusions are not only essential to maintain acceptable hemoglobin levels for treatment of the underlying anemia but also to suppress endogenous erythropoiesis and pathology due to chronic hemolysis. Unfortunately it inevitably leads to iron overload, such that all patients continuing to receive transfusions in excess of 20 blood transfusions are at progressively increased risk of developing signs or symptoms of iron overload. In pazienti con talassemia beta, trasfusioni regolari non solo sono essenziali per mantenere livelli di emoglobina accettabili per il trattamento dell¿anemia che sta alla base, ma anche per reprimere l¿eritropoiesi endogena e la patologia dovuta all¿emolisi cronica. Purtroppo ci¿ porta inevitabilmente a un sovraccarico di ferro tale che tutti i pazienti che continuano a ricevere trasfusioni sanguigne in numero maggiore di 20 corrono un rischio esponenziale di sviluppare segni o sintomi di sovrac, Chronic iron overload (an excess of iron in the body). Sovraccarico cronico di ferro (eccesso di ferro nel corpo)., Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
NCT06553547: 4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Recruiting
2
72
US
Tenapanor, IBSRELA, Placebo
Ardelyx
Irritable Bowel Syndrome with Constipation (IBS-C)
06/26
06/26
NCT06460038: Tenapanor in Synucleinopathy-Related Constipation

Recruiting
2
30
US
Tenapanor, Placebo
Cedar Valley Digestive Health Center, Ardelyx
Synucleinopathy, Parkinson's Disease
12/26
03/27
NCT06203444: An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

Completed
1
7
US
Tenapanor, IBSRELA
Ardelyx
Lactation
05/24
05/24
Hanlikang (rituximab biosimilar) / Fosun Pharma, Eurofarma, Farma de Colombia, Abbott
2020-000736-21: A Phase 3 study to evaluate the efficacy and safety of HLX01 versus rituximab (Mabthera®) as treatment for patients with low tumour burden follicular lymphoma.

Not yet recruiting
3
212
Europe
Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody Injection, Mabthera®, HLX01, Concentrate for solution for infusion, Mabthera®
Shanghai Henlius Biotech Inc., Shanghai Henlius Biotech, Inc.
Low tumour burden follicular lymphoma, Disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes., Diseases [C] - Blood and lymphatic diseases [C15]
 
 
ChiCTR2000034167: A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined with MTX Therapy in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Recruiting
3
267
 
During the 24-week study, subjects will be given one course of treatment with HLX01, After the Week 24 study visit, all subjects will continue to be given one course of treatment with HLX01 ;During the 24-week study, subjects will be given one course of treatment with placebo. After the Week 24 study visit, all subjects will continue to be given one course of treatment with HLX01
Chinese Academy of Medical Sciences Peking Union Medical College; Shanghai Henlius Biotech, Inc., Shanghai Henlius Biotech, Inc.
Rheumatoid Arthritis
 
 
RIPPLE, NCT04246359: Rituximab and Pegylated Interferon α-2b in Patients With Indolent B-cell Lymphoma

Recruiting
2
52
RoW
Rituximab Biosimilar, HLX01, Pegylated Interferon α-2b
Huiqiang Huang
Lymphoma, B-Cell
06/22
01/23
NCT07038382: A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis

Recruiting
2
24
RoW
HLX79 10mg/kg/Placebo+HLX01, HLX79 20mg/kg/Placebo + HLX01, HLX79 30mg/kg/placebo+HLX01
Shanghai Henlius Biotech
Membranous Nephropathy, Lupus Nephritis (LN)
01/27
05/30
ChiCTR2200064195: A clinical study of Hanlikang and BTK inhibitors in the treatment of newly diagnosed mantle cell lymphoma

Recruiting
1
100
 
R-BAP chemotherapy regimen and zanubrutinib ;R-BAP chemotherapy regimen and Ibrutinib
The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University, self-raised
mantle cell lymphoma
 
 
NCT05506410: A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma

Recruiting
N/A
100
RoW
Rituximab, Bendamustine, Cytarabine, Prednisone, BTK inhibitors
Zhengzhou University
Newly Diagnosed Mantle Cell Lymphoma
06/24
12/26
NCT04491721: Follow-up the OS and PFS of Rituximab Biosimilar HLX01 and MabThera, in Untreated Subjects With CD20+ DLBCL

Enrolling by invitation
N/A
407
RoW
Chinese Academy of Medical Sciences
Diffuse Large B Cell Lymphoma
06/27
07/27
HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
NCT04155125: A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient

Completed
3
391
RoW
efepoetin alfa, Mircera
PT Kalbe Genexine Biologics, Novotech (Australia) Pty Limited
Anaemia Associated With Chronic Kidney Disease
03/22
06/23
NCT06466785: A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

Recruiting
3
429
RoW
Efepoetin Alfa, GX-E4, Darbepoetin Alfa, Aranesp®
Genexine, Inc., PT Kalbe Genexine Biologics
Anemia of Chronic Kidney Disease
12/26
09/27
GX-E4-HV-003, NCT06490939: Clinical Trial of Efepoetin Alfa in Healthy Subjects

Recruiting
1
40
RoW
Efepoetin Alfa, GX-E4
Genexine, Inc.
Healthy
02/25
10/25
Hercessi (trastuzumab-strf) / Fosun Pharma, Intas, Eurofarma
ChiCTR2100043780: Real world study of trastuzumab (Zercepac) in the treatment of HER2 positive advanced gastric carcer

Recruiting
4
500
 
Zercepac
Jiangsu Province Cancer Hospital; School of Public Health, Peking University, Henlius
advanced gastric carcer
 
 
ChiCTR2100043781: Real world study of trastuzumab(Zercepac) in the treatment of HER2 positive breast cancer

Recruiting
4
9500
 
Zercepac
Jiangsu Province Cancer Hospital; School of Public Health, Peking University, Henlius
Breast cancer
 
 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Ongentys (opicapone) / Ono Pharma, Neurocrine, BIAL
2020-001175-32: Clinical study to evaluate the effect of opicapone 50 mg in the pain associated to Parkinson’s disease.

Ongoing
4
176
Europe
Ongentys, [BIA 9-1067], Capsule, hard, Ongentys
Bial - Portela & Ca, S.A., BIAL-Portela & Ca, S.A., Bial - Portela & Ca, S.A.
Parkinson's disease patients with wearing-off motor fluctuations andassociated pain., Parkinson's disease result in loss of special nerve cells in the brain. This affects movement, cause tremor and stiffness., Diseases [C] - Nervous System Diseases [C10]
 
 
2020-002754-24: Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. Estudio clínico en pacientes con EP temprana para investigar el efecto de Opicapone 50 mg o Levodopa 100 mg en el tratamiento de las fluctuaciones motoras.

Ongoing
4
100
Europe
Capsule, hard, Tablet, Ongentys 50 mg hard capsules, Madopar 125 mg T, tablets, SINEMET 100 mg + 25 mg tablets
Bial - Portela & Ca, S.A., Bial - Portela & Ca, S.A.
Parkinson's Disease (PD) Enfermedad de Parkinson (EP), Parkinson's Disease (PD) Enfermedad de Parkinson (EP), Diseases [C] - Nervous System Diseases [C10]
 
 
NCT04821687: A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD

Completed
4
169
RoW
Ongentys 50mg, Madopar Tab. 125 or Perkin Tab. 25-100mg
SK Chemicals Co., Ltd.
Parkinson Disease
08/22
08/22
OCEAN, NCT04986982 / 2020-001175-32: OpiCapone Effect on Motor Fluctuations and pAiN

Completed
4
144
Europe
Opicapone 50 mg, BIA 9-1067, Placebo
Bial - Portela C S.A., Bial - Portela & Ca, S.A.
Parkinson Disease
02/24
02/24
2020-001176-15: Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease.

Not yet recruiting
4
30
Europe
Ongentys 50 mg hard capsules, Capsule, Ongentys
Bial - Portela & Ca, S.A., Bial - Portela & Ca, S.A.
Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders., Parkinson's disease patients with associated movement and sleep disorders., Diseases [C] - Nervous System Diseases [C10]
 
 
OASIS, NCT04986995: OpicApone Sleep dISorder

Completed
4
22
Europe
Opicapone, BIA 9-1067
Bial - Portela C S.A.
Parkinson Disease
03/23
03/23
ADOPTION, NCT04990284 / 2020-002754-24: eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.

Completed
4
106
Europe
Opicapone, BIA 9-1067, L-DOPA/DDCI, Levodopa
Bial - Portela C S.A., Bial - Portela & Ca, S.A.
Parkinson Disease
04/23
04/23
2020-005011-52: Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study

Not yet recruiting
3
324
RoW, Europe
Opicapone, BIA 9-1067, Capsule, hard, Ongentys
BIAL – Portela & Cª, S.A., BIAL-Portela & Ca, S.A., BIAL – Portela & Cª, S.A.,
Early Idiopathic Parkinson’s disease, Parkinson’s disease in its early stage, Diseases [C] - Nervous System Diseases [C10]
 
 
EPSILON, NCT04978597: Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe ( Study)

Completed
3
410
Europe
Opicapone 50 mg, Placebo
Bial - Portela C S.A.
Parkinson
01/23
01/24
ChiCTR2300069899: A multicenter, randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of Opicapone in primary Parkinson's disease patients with fluctuating end-of-life motor symptoms after treatment with levodopa/dopamine decarboxylase inhibitors

Not yet recruiting
3
250
 
placebo ;Opicapone 25mg ;Opicapone 50 mg
Ruijin Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Fosun Pharmaceutical (Group) Co., Ltd, Sponsor
Idiopathic Parkinson's disease
 
 
OPAILEC, NCT06432309: Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease

Completed
N/A
22
Europe
Opicapone 50 mg, OPC, Duodopa, Levodopa/carbidopa intestinal gel (LCIG)
University Hospital of Ferrara
Parkinson Disease, Effect of Drug
12/23
04/24
Nerlynx (neratinib) / Puma
ChiCTR2500097583: A multi-center retrospective study of neratinib as extended adjuvant therapy to describe patient characteristics, treatment patterns, safety, and effectiveness in HER2-positive early breast cancer patients in China

Recruiting
4
500
 
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Pierre Fabre (Shanghai) Medical Co.,Ltd., Pierre Fabre (Shanghai) Medical Co.,Ltd.
Breast Cancer
 
 
NCT05760612: A Clinical Study on Hormone Receptor Positive HER2 Positive Breast Cancer of RCB1-2 After Neoadjuvant Treatment with Trastuzumab Combined with Parezumab

Recruiting
3
300
RoW
Trastuzumab and nelatinib, Trastuzumab and Parstuzumab
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Early-stage Breast Cancer, HER2-positive Breast Cancer, Adjuvant Treatment After Trastuzumab, RCB Classification 1-2, Neratini
02/28
11/28
SAFIR-ABC10, NCT05615818: Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting
3
800
Europe
Futibatinib, Ivosidenib, Tibsovo, Zanidatamab, Trastuzumab, Zercepac, Neratinib, Nerlynx, Encorafenib, Braftovi, Binimetinib, Mektovi, Niraparib, Zejula, Cisplatin, Gemcitabine
UNICANCER, Cancer Research UK & UCL Cancer Trials Centre, Belgian Group of Digestive Oncology, National Cancer Institute, France, Cancer Research UK, Taiho Oncology, Inc., Servier, Zymeworks BC Inc., Accord Healthcare, Inc., Pierre Fabre Medicament
Biliary Tract Neoplasms
06/27
06/28
plasmaMATCH, NCT03182634: The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices () Trial

Checkmark Results from cohort B of plasmaMATCH trial in combination with fulvestrant for advanced breast cancer at SABCS 2019
Dec 2019 - Dec 2019: Results from cohort B of plasmaMATCH trial in combination with fulvestrant for advanced breast cancer at SABCS 2019
Recruiting
2a
1150
Europe
Fulvestrant, Neratinib, AZD5363, Olaparib, AZD6738
Institute of Cancer Research, United Kingdom, Royal Marsden NHS Foundation Trust
Advanced Breast Cancer
11/22
11/23
2005-003098-26: Phase 2 Study of HKI-272 in Subjects with Advanced Breast Cancer

Ongoing
2
45
Europe
HKI-272,
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Breast cancer is the most frequently diagnosed malignancy and the second most common cause of cancer related deaths in women. HER2 is a member of the epidermal growth factor receptor (EGFR) family that includes EGFR/HER1, HER2, HER3 and HER4, all being receptor tyrosine-protein kinases. The oncogenic role of HER2 has been extensively documented in breast cancer, where it is overexpressed in 25% to 30% of breast cancers.
 
 
2013-004391-35: A study before surgery evaluating Regimens with Weekly Paclitaxel plus Neratinib or Trastuzumab or Neratinib and Trastuzumab Followed by Doxorubicin and Cyclophosphamide with Postoperative Trastuzumab in Women with Locally Advanced HER2-Positive Breast Cancer. Studio clinico precedente all\'intervento chirurgico per valutare i regimi di Paclitaxel settimanale più Neratinib o Trastuzumab o Neratinib e Trastuzumab seguito da Doxorubicina e Ciclofosfamide con Trastuzumab postoperatorio in donne con tumore alla mammella HER2-positivo localmente avanzato.

Ongoing
2
33
Europe
Neratinib, PB-272; HKI-272, Herceptin, Herceptin
Puma Biotechnology Inc., Puma Biotechnology, Inc
Locally advanced HER2-positive breast cancer tumore alla mammella HER2-positivo localmente avanzato
 
 
2019-001896-35: A Clinical Study to Investigate Colon Pathology in Patients With Breast Cancer And HER2 Overexpression When Treated With Neratinib Um estudo clínico para investigar a patologia do cólon em doentes com cancro da mama e sobre-expressão de HER2 quando tratados com Neratinib

Not yet recruiting
2
5
Europe
Neratinib, PB-272; HKI-272, Film-coated tablet
Puma Biotechnology, Inc, Puma Biotechnology, Inc.
HER2 amplified (HER2+) stage 1 through stage 4 primary adenocarcinoma of the breast Adenocarcinoma da mama primário em estadio 1 até ao estadio 4 com amplificação do HER2 (HER2+), Breast Cancer with HER2 gene overexpression Cancro da mama com sobre-expressão do gene HER2, Diseases [C] - Cancer [C04]
 
 
2019-000710-11: Clinical study with Neratinib in Metastatic breast cancer Estudio clínico con Neratinib en cancer de mama metastásico

Not yet recruiting
2
62
Europe
Neratinib, PB-272; HKI-272, Film-coated tablet, Nerlynx
SOLTI, PUMA BIOTECHNOLOGY INC
Pre and post-menopausal women and men with locally advanced or metastatic HR+/HER2-negative endocrine resistant breast cancer Hombres y Mujeres pre y posmenopáusicas con cáncer de mama localmente avanzado o metastásico RH+/HER2-negativo resistente al tratamiento endocrino, Breast cancer Cancer de mama, Diseases [C] - Cancer [C04]
 
 
FACT-2, NCT03812393: Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast

Hourglass Oct 2021 - Mar 2022 : Interim data from FACT-2 trial for early stage TNBC-negative that respond to pan-HER drugs
Active, not recruiting
2
27
US
Neratinib, Live Cell HER2 signaling Transduction Analysis (CELx)
West Cancer Center, Celcuity Inc, Puma Biotechnology, Inc.
Triple Negative Breast Cancer, Early-stage Breast Cancer, HER2-positive Breast Cancer
12/24
12/24
NCT03289039: Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer

Terminated
2
21
US
Neratinib, Nerlynx, Fulvestrant, Faslodex
Dana-Farber Cancer Institute, Puma Biotechnology, Inc.
Breast Cancer
07/21
07/21
NSABP FC-11, NCT03457896: Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status

Active, not recruiting
2
35
US
Trastuzumab, Cetuximab, Neratinib, Nerlynx, Guardant360 Diagnostic Test
NSABP Foundation Inc, Puma Biotechnology, Inc.
Metastatic Colorectal Cancer
09/21
09/22
2020-000824-21: An open label phase II study to evaluate neratinib for treatment and prevention of subsequent CNS event(s) in patients with brain metastasis of advanced HER2 positive breast cancer

Not yet recruiting
2
125
Europe
neratinib, capecitabine, trasntuzumab emtansine, paclitaxel, vinorelbine, herceptin, Film-coated tablet, Powder and solvent for concentrate for solution for infusion, Concentrate and solvent for solution for injection, Concentrate for solution for injection, Powder for concentrate for solution for infusion
Institut Jules Bordet, PUMA
HER2 positive breast cancer patients with brain metastases, HER2 positive breast cancer patients with brain metastases, Diseases [C] - Cancer [C04]
 
 
2019-001559-38: Phase II study to evaluate diarrhoea discontinuations at 3 cycles in patients with early-stage HER2 positive, hormone receptor positive breast cancer treated with neratinib plus loperamide versus neratinib dose escalation plus loperamide administered as needed versus neratinib plus loperamide plus colesevelam Estudio fase II para evaluar la incidencia de abandono debida a diarrea en 3 ciclos de tratamiento en pacientes con cáncer de mama estadio temprano HER2 positivo, receptor hormonal positivo tratados con neratinib más loperamida frente a neratinib con escalada de dosis más loperamida administrada solamente según necesidad frente a neratinib más loperamida más colesevelam

Not yet recruiting
2
315
Europe
Neratinib, Loperamide, Colesevelam, PB-272; HKI-272, Film-coated tablet, Capsule, hard, Nerlynx, Sindiar, Cholestagel
GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama), PUMA BIOTECHNOLOGY, INC
HER2+, HR+ Early stage Breast Cancer Cáncer de Mama Precoz HER2+, RH+, HER2 positive, Hormone Receptor positive Early-stage Breast Cancer Cáncer de mama precoz HER2 positivo, receptor hormonal positivo, Diseases [C] - Cancer [C04]
 
 
TBCRC 022, NCT01494662: HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

Hourglass Jan 2022 - Jun 2022 : Data from trial in combination with neratinib for HER2-positive breast cancer with brain metastases
Hourglass Jul 2021 - Dec 2021 : Data from cohort 4 of P2 trial in combination with kadcyla for HER2-positive breast cancer
Checkmark Pooled data from NALA, NEfERT-T and TBCRC 022 trials for HER2-positive breast cancer at SABCS 2019
Dec 2019 - Dec 2019: Pooled data from NALA, NEfERT-T and TBCRC 022 trials for HER2-positive breast cancer at SABCS 2019
Checkmark In HER2+ metastatic breast cancer with brain metastases
More
Active, not recruiting
2
140
US
HKI-272, Neratinib, Surgical Resection, Biopsy, Capecitabine, Xeloda, Ado-Trastuzumab Emtansine, T-DM1
Dana-Farber Cancer Institute, Translational Breast Cancer Research Consortium, Puma Biotechnology, Inc.
Breast Cancer
02/23
12/25
2022-002582-15: Phase II Study mit Neratinib and Trastuzumab with or without Vinorelbine per mouth in patients with pretreated metastatic Her2- positive breast cancer Phase II Study mit Neratinib and Trastuzumab with or without Vinorelbine per mouth in patients with pretreated metastatic Her2- positive breast cancer

Ongoing
2
65
Europe
Neratinib, Navelbine, PRD7433212, L01CA04, Film-coated tablet, Capsule, Nerlynx, Navelbine
Medical University Graz, Pierre Fabre
Patients with histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive metastatic breast cancer (mBC) pretreated with trastuzumab, pertuzumab, and/or trastuzumab emtansine (T-DM1) and/ or T-DXd and/or tucatinib Patientinnen mit histologisch bestätigten Human Epidermen Wachstumsfaktor Rezeptor 2 (Her2) positiven metasierten Brustkrebserkrankung, vorbehandelt mit Trastuzumab, Pertuzumab und/ oder Trastuzumab Emtansine (T-DM1) und/ oder Trastuzumab Deruxtecan und/ oder Tucatinib, Patients with Her2 positive metastatic breast cancer who were pretreted with 2-4 lines of previous treatment Patientinnen mit Her2 positiven metastasierten Brustkrebserkrankung die mit 2-4 Therapielinien vorbehandelt wurden, Diseases [C] - Cancer [C04]
 
 
NCT04886531: Trial of Pre-operative Neratinib and Endocrine Therapy with Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

Recruiting
2
30
US
Neratinib, Nerlynx, Letrozole (L) or Anastrozole (A), Femara, Arimidex, Trastuzumab, Herceptin
Ruth O'Regan, Puma Biotechnology, Inc., University of Rochester
Breast Cancer, HER2-positive Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
09/25
10/25
NCT05512182: Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression

Withdrawn
2
50
RoW
Chemotherapy
Yonsei University
Recurrent/Advanced Gastric Cancer
10/23
10/23
KCSG AL20-17, NCT06083662: Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers

Completed
2
42
RoW
Neratinib Maleate, Herzuma
Korea University Guro Hospital, Korean Cancer Study Group
Metastatic Cancer, HER2 Gene Mutation
11/23
12/24
DIANER, NCT05252988: Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib

Active, not recruiting
2
177
Europe
Neratinib, Nerlynx, Loperamide, Sindiar, Colesevelam, Cholestagel
Spanish Breast Cancer Research Group, Puma Biotechnology, Inc., Pierre Fabre Laboratories
Early-stage Breast Cancer, HER2 Positive Breast Cancer, Hormone Receptor Positive
10/24
01/30
NCT05154396: Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

Not yet recruiting
2
60
NA
Neratinib, Loperamide prophylaxis
Chinese Academy of Medical Sciences
HER2-positive Breast Cancer
12/23
12/24
CVL009-2002, NCT06374888: Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases

Not yet recruiting
2
28
NA
Neratinib maleate in combination with capecitabine
Convalife (Shanghai) Co., Ltd.
Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis
09/26
07/27
NCT06126276: Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

Recruiting
2
70
US
Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Echocardiography Test, EC, Echocardiography, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Neratinib Maleate, 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1), HKI-272 Maleate, NERATINIB MALEATE ANHYDROUS, Nerlynx, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, PD0332991
National Cancer Institute (NCI)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm
02/27
02/27
HER2-Signal, NCT04901299: Fulvestrant + Neratinib In Breast Cancer

Withdrawn
2
25
US
NERATINIB, Nerlynx, FULVESTRANT, Faslodex
Massachusetts General Hospital, Celcuity, Inc., Puma Biotechnology, Inc.
Stage IV (Metastatic) Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer, HER2-negative Breast Cancer, Invasive Breast Cancer
07/24
07/25
CVL009-C2001, NCT06519110: Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations

Not yet recruiting
2
60
NA
Neratinib tablets, Neratinib
Convalife (Shanghai) Co., Ltd.
Advanced Solid Tumor
02/26
04/26
NCT04965064: Trial of Neratinib Plus Capecitabine in Subjects with HER2-Negative Metastatic Breast Cancer with Brain Metastases and Abnormally Active HER2 Signaling

Recruiting
2
22
US
Capecitabine and Neratinib.
University of Rochester
Breast Cancer
09/26
09/27
NCT04760431: TKIs vs. Pertuzumab in HER2+ Breast Cancer Patients With Active Brain Metastases (HER2BRAIN)

Not yet recruiting
2
120
RoW
Trastuzumab, Herceptin, Taxanes, Docetaxel, Paclitaxel, Paclitaxel (Albumin bound), Paclitaxel Liposome, Pertuzumab, Perjeta, Tyrosine kinase inhibitor, Pyrotinib, Neratinib, Tucatinib
Second Affiliated Hospital, School of Medicine, Zhejiang University, Peking University International Hospital, Sun Yat-sen University, Zhejiang University
HER2-positive Breast Cancer, Brain Metastases
09/24
09/25
CVL009-2001, NCT06029816: Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations

Not yet recruiting
2
42
RoW
Neratinib tablets, Epilepsy
Convalife (Shanghai) Co., Ltd.
NSCLC
12/24
12/25
SPRING, NCT06692491: Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

Not yet recruiting
2
200
NA
Albumin-Bound Paclitaxel, Abraxane, Epirubicin, Ellence, Gemcitabine, Gemzar, Vinorelbine, Navelbine, Vumon, Cisplatin, Platinol, Irinotecan, Camptosar, Fluorouracil, Adrucil, 5-FU, Nivolumab, Opdivo, Pembrolizumab, Keytruda, Durvalumab, Imfinzi, Atezolizumab, Tecentriq, Sintilimab, Tyvyt, Tislelizumab, Baizean, Camrelizumab, AiRuiKa, Toripalimab, Tuoyi, Serplulimab, Hansizhuang, Adebrelimab, Abesive, Envafolimab, Epkinly, Osimertinib, Tagrisso, Alectinib, Alecensa, Vemurafenib, Zelboraf, Pamiparib, Balversa, Pyrotinib, Nerlynx, Imatinib, Gleevec, Palbociclib, Ibrance, Savolitinib, Orpathys, Entrectinib, Rozlytrek, Other
Peking University Shenzhen Hospital
Rare Tumour
12/27
12/29
NCT06813079: Using Tumor Models to Determine Treatments

Not yet recruiting
2
25
Canada
Cobimetinib, Ponatinib, Brigatinib, Colchicine, Selinexor, Abemaciclib, Neratinib, Doxorubicin, Etoposide, Ceritinib
University Health Network, Toronto
Pancreatic Ductal Carcinoma, Advanced Cancer, Epithelial Tumor
02/28
02/28
INSIGhT, NCT02977780: INdividualized Screening Trial of Innovative Glioblastoma Therapy

Recruiting
2
460
US
Temozolomide, Temodar, Neratinib, QBS10072S
Patrick Wen, MD, Eli Lilly and Company, Celgene, Puma Biotechnology, Inc., Accelerate Brain Cancer Cure, Quadriga Biosciences, Inc.
Glioblastoma
02/27
04/27
KAN-HER2 MRD, NCT05388149: Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease

Recruiting
2
15
Canada
Neratinib, NERLYNX
University Health Network, Toronto
Breast Cancer, HER2-positive Breast Cancer
07/26
07/26
NCT06109467: Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer

Recruiting
2
36
US
Neratinib, NERLYNX, Trastuzumab, Herceptin, Oxaliplatin, Eloxatin, 5-Fluorouracil + leucovorin, Pembrolizumab, Keytruda
H. Lee Moffitt Cancer Center and Research Institute, Puma Biotechnology, Inc., National Comprehensive Cancer Network
GastroEsophageal Cancer, Gastric Cancer
04/28
04/28
VICC-NCBRE23172, NCT05919108: Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

Recruiting
2
30
US
Endocrine Therapy, Biopsy of breast, Neratinib, Biospecimen Collection, Mammogram, Magnetic Resonance Imaging, Breast Surgery, Ultrasound
Vanderbilt-Ingram Cancer Center, National Cancer Institute (NCI), Puma Biotechnology, Inc.
Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma
04/30
04/31
INTUITT-NF2, NCT04374305: Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis

Active, not recruiting
2
100
US
Brigatinib, Alunbrig, Neratinib, Nerlynx
Scott R. Plotkin, MD, PhD, Takeda, The Children's Tumor Foundation, National Comprehensive Cancer Network
Neurofibromatosis Type 2, Vestibular Schwannoma, Non-vestibular Schwannoma, Meningioma, Ependymoma
12/29
12/30
NCT05564377: Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Recruiting
2
2900
US
Alpelisib, BYL 719, BYL-719, BYL719, Phosphoinositide 3-kinase Inhibitor BYL719, Piqray, VIJOICE, Binimetinib, ARRY 162, ARRY 438162, ARRY-162, ARRY-438162, ARRY162, ARRY438162, MEK 162, MEK-162, MEK162, Mektovi, Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Scan, Bone Scintigraphy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Echocardiography Test, EC, Echocardiography, Fluorouracil, 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757, Fulvestrant, Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780, ICI-182780, ICI182780, ZD 9238, ZD-9238, ZD9238, Ipatasertib, GDC 0068, GDC-0068, GDC0068, RG 7440, RG-7440, RG7440, Leucovorin, Folinic acid, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Mutation Carrier Screening, Neratinib Maleate, 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1), HKI-272 Maleate, NERATINIB MALEATE ANHYDROUS, Nerlynx, Nilotinib Hydrochloride Monohydrate, AMN 107, AMN-107, AMN107, Nilotinib Monohydrochloride Monohydrate, Tasigna, Olaparib, AZD 2281, AZD-2281, AZD2281, KU 0059436, KU-0059436, KU0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281, Oxaliplatin, 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, Elplat, JM 83, JM-83, JM83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, RP54780, SR 96669, SR-96669, SR96669, Paclitaxel, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, PD0332991, Panitumumab, ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, E7.6.3, Human IgG2K Monoclonal Antibody, MoAb ABX-EGF, MoAb E7.6.3, Monoclonal Antibody ABX-EGF, Monoclonal Antibody E7.6.3, Vectibix, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Selumetinib Sulfate, AZD-6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulfate, AZD6244 Hydrogen Sulphate, Koselugo, Selumetinib Sulphate, Sotorasib, AMG 510, AMG-510, AMG510, Lumakras, Lumykras
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable HER2-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm
07/30
07/30
GERTRUDE, NCT05933395: Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Recruiting
2
135
US
Fulvestrant, Neratinib, Alpelisib, Everolimus, Abemaciclib
Dartmouth-Hitchcock Medical Center
Advanced Breast Cancer
10/30
10/31
I-SPY 2, NCT01042379: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Hourglass Jan 2023 - Dec 2023 : From P2 I-SPY 2 trial for invasive breast cancer
Checkmark Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Checkmark Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
Nov 2018 - Nov 2018: Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
More
Recruiting
2
5000
US
Standard Therapy, Paclitaxel (Taxol); Doxorubicin (Adriamycin), AMG 386 with or without Trastuzumab, AMG 386 (Trebananib); (Trastuzumab) Herceptin, AMG 479 (Ganitumab) plus Metformin, Ganitumab, MK-2206 with or without Trastuzumab, (Trastuzumab) Herceptin, AMG 386 and Trastuzumab, AMG 386 (Trebananib); Trastuzumab (Herceptin), T-DM1 and Pertuzumab, T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta), Pertuzumab and Trastuzumab, Pertuzumab (Perjeta); Trastuzumab (Herceptin), Ganetespib, ABT-888, Veliparib, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin), SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, SAR439859, Amcenestrant + Abemaciclib, Amcenestrant (SAR439859), Abemaciclib (Verzenio), Amcenestrant + Letrozole, Amcenestrant (SAR439859), Letrozole (Femara), ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, VOYAGER V1™, VSV-IFNβ-NIS, Datopotamab deruxtecan, Dato-DXd, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel
QuantumLeap Healthcare Collaborative
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
12/30
12/31
2006-006412-29: A Phase 1 / 2 Study of HKI-272 in combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer

Ongoing
1/2
95
Europe
HKI-272, PACLITAXEL 6MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION, Capsule*, Concentrate for solution for infusion, Paclitaxel 6mg/ml Concentrate for Solution for Infusion
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Metastatic breast cancer remains incurable and represents an area of unmet medical need globally. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) activation occurs in breast cancer. This activation contributes to the development and metastatic potential of breast cancer. Dual EGFR/HER2 inhibitors may have activity in the treatment of prior trastuzumab treated HER2 positive metastatic breast cancer.
 
 
2006-003215-52: Estudio de Fase I/II de HKI-272 en combinación con trastuzumab (Herceptin) en sujetos con cáncer de mama avanzadoA Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer.

Ongoing
1/2
12
Europe
HKI-272, Herceptin - Powder for concentrate for solution for infusion - trastuzumab 150 mg, Herceptin - Powder for concentrate for solution for infusion - trastuzumab 150 mg
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Advanced HER2 breast cancer. HER2 is a member of the epidermal growth factor (EGFR) family of receptors involved in cell proliferation, tumorigenesis, and metastasis and abnormally expressed in multiple tumor types. EGFR may also be over-expressed in breast cancer, play a role in tumorigenesis, and also confers a worse prognosis. Coexpression of EGFR family (HER1, 2 and 3) has been associated with a negative synergistic effect on 15-year disease specific survival of breast cancer patients.
 
 
2008-001662-85: Phase 1/2 Randomized, Open-label, Three Arm Study of Neratinib (HKI-272) vs. Neratinib + Capecitabine vs. Lapatinib + Capecitabine, in Subjects with Solid Tumors and ErbB-2 Positive Metastatic or locally advanced Breast Cancer

Ongoing
1/2
40
Europe
neratinib, HKI-272, XELODA 150 mg comprimidos recubiertos con película, TYVERB 250 mg comprimidos recubiertos con película, XELODA 150 mg comprimidos recubiertos con película, TYVERB 250 mg comprimidos recubiertos con película
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Solid tumors (part 1) and metastatic breast cancer (part 2)
 
 
NCT03919292: Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca

Recruiting
1/2
83
US
Neratinib, Nerlynx, Divalproex Sodium, Depakote, Valproate
Virginia Commonwealth University, Puma Biotechnology, Inc.
Solid Tumor, Adult
05/26
05/27
NCT02932280: Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment

Active, not recruiting
1/2
14
Canada, US
Neratinib
Memorial Sloan Kettering Cancer Center, Milton S. Hershey Medical Center, M.D. Anderson Cancer Center, Stanford University, Arkansas Children's Hospital Research Institute, Alberta Children's Hospital, Phoenix Children's Hospital, University of Texas
Solid Tumor, Central Nervous System Tumor, Lymphoma, Leukemia
10/25
10/25
NCT03377387: Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer

Active, not recruiting
1/2
34
US
Capecitabine, Neratinib, EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30
Memorial Sloan Kettering Cancer Center, Puma Biotechnology, Inc.
Breast Cancer
12/26
12/26
NCT03101748: Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer

Terminated
1/2
34
US
Cyclophosphamide, (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Laboratory Biomarker Analysis, Neratinib, (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272, Paclitaxel, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, Pertuzumab, 2C4, 2C4 Antibody, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Perjeta, rhuMAb2C4, RO4368451, Trastuzumab, ABP 980, ALT02, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, c-erb-2 Monoclonal Antibody, HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, Herzuma, Kanjinti, MoAb HER2, Monoclonal Antibody c-erb-2, Monoclonal Antibody HER2, Ogivri, Ontruzant, PF-05280014, rhuMAb HER2, RO0452317, SB3, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar ALT02, trastuzumab biosimilar EG12014, Trastuzumab Biosimilar HLX02, Trastuzumab Biosimilar PF-05280014, Trastuzumab Biosimilar SB3, Trastuzumab Biosimilar SIBP-01, Trastuzumab-anns, Trastuzumab-dkst, Trastuzumab-dttb, Trastuzumab-pkrb, Trastuzumab-qyyp, Trazimera
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Breast Inflammatory Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7
05/25
05/25
NCT05243641: Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

Terminated
1/2
10
US
Neratinib, Capmatinib
M.D. Anderson Cancer Center, Celcuity Inc, Novartis, Puma Biotechnology, Inc.
Metastatic Breast Cancer, Breast Cancer
11/24
11/24
iNNOVATE, NCT04502602: Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer

Active, not recruiting
1
18
US
Neratinib 160 mg, Neratinib 200 mg, Neratinib 240 mg, Niraparib 100 mg, Niraparib 200 mg, Niraparib 300 mg, Niraparib at RP2D, Neratinib at RP2D
Virginia Commonwealth University, Puma Biotechnology, Inc., GlaxoSmithKline
Advanced Solid Tumor, Ovarian Cancer
08/26
05/29
NCI 10495, NCT05372614: Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene

Recruiting
1
30
US
Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Echocardiography Test, EC, Echocardiography, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Neratinib Maleate, 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1), HKI-272 Maleate, NERATINIB MALEATE ANHYDROUS, Nerlynx, Trastuzumab Deruxtecan, DS-8201, DS-8201a, Enhertu, Fam-trastuzumab Deruxtecan-nxki, T-DXd, WHO 10516
National Cancer Institute (NCI)
Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
12/25
12/25
NCT05274048: Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients

Recruiting
1
18
US
Neratinib Pill, Fam-Trastuzumab Deruxtecan-Nxki (TDxD)
Fox Chase Cancer Center, National Comprehensive Cancer Network, Puma Biotechnology, Inc.
Gastric Cancer, Gastrointestinal Cancer, HER2 Gene Mutation
06/25
06/27
NCT06008275: Neratinib in Combination With Ruxolitinib in Patients With mTNBC

Recruiting
1
20
US
Neratinib Oral Tablet, Ruxolitinib Oral Tablet, Jakafi
Baylor Research Institute
Metastatic Triple-Negative Breast Carcinoma, Breast Cancer
06/26
12/26
SMMART, NCT03878524: Serial Measurements of Molecular and Architectural Responses to Therapy () PRIME Trial

Terminated
1
2
US
Abemaciclib, LY-2835219, LY2835219, Verzenio, Abiraterone, CB 7598, Afatinib, BIBW 2992, BIBW2992, Bevacizumab, ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev, Anti-VEGF Monoclonal Antibody SIBP04, SIBP 04, SIBP-04, SIBP04, Bicalutamide, Casodex, Cosudex, ICI 176,334, ICI 176334, Biospecimen Collection, Biological Sample Collection, Specimen Collection, Bortezomib, [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade, Cabazitaxel, Jevtana, RPR-116258A, Taxoid XRP6258, XRP-6258, Cabozantinib, Capecitabine, Ro 09-1978/000, Xeloda, Carboplatin, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo, Celecoxib, Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177, Cobimetinib, Cotellic, GDC-0973, MEK Inhibitor GDC-0973, XL518, 934660-93-2, Copanlisib, BAY 80-6946, PI3K Inhibitor BAY 80-6946, Dabrafenib, BRAF Inhibitor GSK2118436, GSK-2118436, GSK-2118436A, GSK2118436, Dacomitinib, EGFR Inhibitor PF-00299804, PF-00299804, PF-00299804-03, PF-299804, Vizimpro, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, 1297538-32-9, Dasatinib, BMS-354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Durvalumab, Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736, 1428935-60-7, Enasidenib, AG-221, CC-90007 Free Base, Entrectinib, Rozlytrek, RXDX 101, RXDX-101, RXDX101, Enzalutamide, ASP9785, MDV3100, Xtandi, Erlotinib, Everolimus, 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress, Fluorouracil, 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757, Idelalisib, CAL-101, GS 1101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig, Imatinib, Ipilimumab, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy, Lenvatinib, E7080, ER-203492-00, Multi-Kinase Inhibitor E7080, Leucovorin, Folinic acid, Lorlatinib, 2H-4,8-Methenopyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-, Lorbrena, PF-06463922, Losartan, Nab-paclitaxel, ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel, Neratinib, (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272, Nivolumab, BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo, Olaparib, AZD 2281, AZD-2281, AZD2281, KU-0059436, Lynparza, PARP Inhibitor AZD2281, Oxaliplatin, 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, Panobinostat, Faridak, LBH589, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Pertuzumab, 2C4, 2C4 Antibody, HS627, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Perjeta, Pertuzumab Biosimilar HS627, rhuMAb2C4, RO4368451, HLX11, Ponatinib, AP-24534, AP24534, Quality-of-Life Assessment, Quality of Life Assessment, Regorafenib, BAY 73-4506, REGORAFENIB ANHYDROUS, Stivarga, Ruxolitinib, INCB-18424, INCB18424, Jakafi, Oral JAK Inhibitor INCB18424, Sirolimus, AY 22989, RAPA, Rapamune, Rapamycin, SILA 9268A, WY-090217, Sorafenib, BA4 43 9006, BAY 43-9006, Bay-439006, Sunitinib, Trametinib, GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Trastuzumab Emtansine, Ado Trastuzumab Emtansine, ADO-Trastuzumab Emtansine, Kadcyla, PRO132365, RO5304020, T-DM1, Trastuzumab-DM1, Trastuzumab-MCC-DM1, Trastuzumab-MCC-DM1 Antibody-Drug Conjugate, Trastuzumab-MCC-DM1 Immunoconjugate, Tretinoin, 2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-, Aberel, Airol, Aknoten, all trans-Retinoic acid, All-trans Retinoic Acid, All-trans Vitamin A Acid, all-trans-Retinoic acid, all-trans-Vitamin A acid, ATRA, Avita, beta-Retinoic Acid, Cordes Vas, Dermairol, Epi-Aberel, Eudyna, Renova, Retin-A, Retin-A MICRO, Retin-A-Micro, Retinoic Acid, Retisol-A, Ro 5488, Stieva-A, Stieva-A Forte, Trans Retinoic Acid, Trans Vitamin A Acid, trans-Retinoic Acid, Tretinoinum, Vesanoid, Vitamin A Acid, Vitamin A acid, all-trans-, Vitinoin, Vemurafenib, BRAF (V600E) kinase inhibitor RO5185426, BRAF(V600E) Kinase Inhibitor RO5185426, PLX-4032, PLX4032, RG 7204, RG7204, RO 5185426, Zelboraf, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto, Vismodegib, Erivedge, GDC-0449, Hedgehog Antagonist GDC-0449, Vorinostat, L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
OHSU Knight Cancer Institute, Oregon Health and Science University
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Anatomic Stage IV Breast Cancer AJCC v8, Anemia, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Castration-Resistant Prostate Carcinoma, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Pancreatic Adenocarcinoma, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Primary Myelofibrosis, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Hematologic Malignancy, Recurrent Hodgkin Lymphoma, Recurrent Myelodysplastic Syndrome, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Chronic Myelomonocytic Leukemia, Refractory Hematologic Malignancy, Refractory Hodgkin Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Myelodysplastic Syndrome, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Refractory Primary Myelofibrosis, Refractory Small Lymphocytic Lymphoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma
12/20
12/20
NCI-2018-01218, NCT03065387: Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation

Active, not recruiting
1
93
US
Everolimus, 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress, Neratinib, (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, Trametinib, GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Mekinist
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm, EGFR Gene Amplification, EGFR Gene Mutation, ERBB2 Gene Amplification, ERBB2 Gene Mutation, ERBB3 Gene Mutation, ERBB4 Gene Mutation, KRAS Gene Mutation, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
10/25
10/25
NCT01956253: Single Subject Neratinib in Bladder Cancer (NRR)

No Longer Available
N/A
US
Neratinib
UNC Lineberger Comprehensive Cancer Center
Bladder Cancer
09/13
06/14
NeraHER2, NCT06693024: Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

Recruiting
N/A
2806
RoW
neratinib
Shu Wang
HER2-positive Breast Cancer
12/31
12/31
ChiCTR2200055875: Effects of natural plant extracts (targeted inhibitors: PD0325901/AZ-628/ Neratinib/Selumetinib/ VX-11E) on chondrocyte and osteoclast microenvironment in osteoarthritis and its mechanism

Recruiting
N/A
100
 
No intervention ;No intervention
Taizhou Hospital of Zhejiang Province; Taizhou Hospital of Zhejiang Province, Zhejiang Provincial Natural Science Foundation Of China (GF18H060033), Taizhou Key Disciplines Foundation of China (ZDXK202010150001), Taizhou Key Disciplines Group Foundation of China (ZDXK202010150027), Academician Dai Kerong Workstation Research Fund Project (RCZX201907240001)
Osteoarthritis, osteoporosis
 
 
ELEANOR, NCT04388384: Real-life Pan-HER-blockade With Neratinib

Active, not recruiting
N/A
304
Europe
Neratinib, Nerlynx
Pierre Fabre Pharma GmbH, iOMEDICO AG, Pierre Fabre Pharma Austria, Pierre Fabre Pharma AG
Breast Neoplasm
01/25
01/25
NCT06892093: Probiotics for Prevention of Pyrotinib/Neratinib-Induced Diarrhea in Breast Cancer Patients

Not yet recruiting
N/A
308
RoW
Probiotics, Placebo
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Jiangnan University
HER2-positive Breast Cancer, Diarrhea Caused by Drug, Neratinib, Pyrotinib
06/27
12/27
NCT07019272: Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study

Not yet recruiting
N/A
170
NA
Neratinib (HKI-272)
Hebei Medical University Fourth Hospital
HER2-positive Breast Cancer
07/29
10/30
ChiCTR2300074308: Efficacy and safety of Disitamab Vedotin plus pyrotinib or naratinib in HER2-positive breast cancer patients with brain metastasis

Not yet recruiting
N/A
20
 
Disitamab Vedotin with pyrotinib or neratinib
Xi'an International Medical Center Hospital; Xi'an International Medical Center Hospital, Hangzhou Oriental Clinical Oncology Research Center
Breast cancer
 
 
NEAR, NCT05599334: A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib

Recruiting
N/A
130
Europe
Pierre Fabre Medicament, Iqvia Pty Ltd
Breast Cancer, Adjuvant Therapy, HER2-positive Breast Cancer
02/23
02/23
NER-Tree, NCT05491057: Treatment Patterns of Neratinib in HER2+ EBC in China

Not yet recruiting
N/A
500
RoW
Neratinib
Pierre Fabre Medicament
Breast Cancer
12/25
06/26
Fablyn (lasofoxifene) / Sermonix
ELAINE 3, NCT05696626: Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Recruiting
3
500
Europe, Canada, US, RoW
Lasofoxifene in combination with abemaciclib, Fulvestrant in combination with abemaciclib
Sermonix Pharmaceuticals Inc.
Metastatic Breast Cancer
04/27
04/28
ChiCTR2400090280: An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men with Locally Advanced or Metastatic ER+/HER2− Breast Cancer with an ESR1 Mutation

Not yet recruiting
3
400
 
Oral lasofoxifene tartrate+ abemaciclib; Oral abemaciclib, intramuscular fluvestrant
Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center, Shanghai Henlius Biotech Co., Ltd
Breast Cancer
 
 
2020-005936-31: An Open-label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer with an estrogen receptor mutation

Not yet recruiting
2
100
Europe
Lasofoxifene, Tablet, Solution for injection, FASLODEX
Sermonix Pharmaceuticals, Sermonix Pharmaceuticals
Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation, Locally Advanced or Metastatic Breast Cancer with an estrogen receptor mutation, Diseases [C] - Cancer [C04]
 
 
ELAINEII, NCT04432454: Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Completed
2
29
US
Lasofoxifene and abemaciclib (VERZENIO (R)).
Sermonix Pharmaceuticals Inc.
Metastatic Breast Cancer
01/25
01/25
ELAINE 1, NCT03781063 / 2020-005936-31: Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Active, not recruiting
2
100
Canada, US, RoW
Lasofoxifene, Fulvestrant
Sermonix Pharmaceuticals Inc., Linical Accelovance Group
Locally Advanced or Metastatic Breast Cancer
12/24
12/24
NCT06197568: Open-Label Study of Vaginal AZU-101 in Postmenopausal Women

Not yet recruiting
1/2
35
NA
Lasofoxifene Tartrate (AZU-101), AZU-101
Azure Biotech Inc.
Postmenopausal Symptoms
09/24
12/24
Ibsrela (tenapanor) / Ardelyx
NCT06481150: A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Recruiting
4
10
US
Tenapanor, XPHOZAH, IBSRELA, Placebo
University of Texas Southwestern Medical Center, National Center for Advancing Translational Sciences (NCATS)
Hyperoxaluria
06/25
08/25
NCT05995899: Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

Recruiting
4
30
US
Tenapanor
Kyle Staller, MD, MPH, Ardelyx
IBS, IBS - Irritable Bowel Syndrome
11/26
11/26
ChiCTR2300068249: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study for the Efficacy and Safety of Tenapanor Tablets in the Treatment of Hyperphosphatemia in Patients with End-Stage Renal Disease on Hemodialysis (ESRD-HD)

Completed
3
160
 
oral ;oral
Peking University People's Hospital; Fosun Pharmaceutical Development Co, Ltd., Sponsor
Hyperphosphatemia in ESRD-HD patients
 
 
NCT04771780: Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Completed
3
213
Japan
KHK7791
Kyowa Kirin Co., Ltd.
Hyperphosphatemia
06/22
06/22
NCT05643534: Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Recruiting
3
180
US
Tenapanor 50 MG, Tenapanor 25 mg bid, Placebo
Ardelyx
Irritable Bowel Syndrome With Constipation (IBS-C)
12/25
12/25
NCT06810167: Assessing Tenapanor as a Treatment of CF-related Constipation.

Recruiting
3
25
US
Tenapanor
Massachusetts General Hospital, Ardelyx
Cystic Fibrosis, Constipation
02/26
06/27
NCT05905926: Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Enrolling by invitation
3
150
US
Tenapanor, Ibsrela
Ardelyx
Irritable Bowel Syndrome With Constipation (IBS-C)
07/31
10/31
2014-005086-70: N/A non disponibile

Not yet recruiting
2
130
Europe
FBS0701 capsule, FBS0701 CAPSULE, FBS0701/SSP004184, FBS0701, FBS0701 /SSP004184, Capsule, hard
SHIRE DEVELOPMENT LLC AND INTERNATIONAL AFFILIATES, Shire Development LLC and International Affiliates
n patients with B-thalassemia, regular transfusions are not only essential to maintain acceptable hemoglobin levels for treatment of the underlying anemia but also to suppress endogenous erythropoiesis and pathology due to chronic hemolysis. Unfortunately it inevitably leads to iron overload, such that all patients continuing to receive transfusions in excess of 20 blood transfusions are at progressively increased risk of developing signs or symptoms of iron overload. In pazienti con talassemia beta, trasfusioni regolari non solo sono essenziali per mantenere livelli di emoglobina accettabili per il trattamento dell¿anemia che sta alla base, ma anche per reprimere l¿eritropoiesi endogena e la patologia dovuta all¿emolisi cronica. Purtroppo ci¿ porta inevitabilmente a un sovraccarico di ferro tale che tutti i pazienti che continuano a ricevere trasfusioni sanguigne in numero maggiore di 20 corrono un rischio esponenziale di sviluppare segni o sintomi di sovrac, Chronic iron overload (an excess of iron in the body). Sovraccarico cronico di ferro (eccesso di ferro nel corpo)., Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
NCT06553547: 4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Recruiting
2
72
US
Tenapanor, IBSRELA, Placebo
Ardelyx
Irritable Bowel Syndrome with Constipation (IBS-C)
06/26
06/26
NCT06460038: Tenapanor in Synucleinopathy-Related Constipation

Recruiting
2
30
US
Tenapanor, Placebo
Cedar Valley Digestive Health Center, Ardelyx
Synucleinopathy, Parkinson's Disease
12/26
03/27
NCT06203444: An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

Completed
1
7
US
Tenapanor, IBSRELA
Ardelyx
Lactation
05/24
05/24
Hanlikang (rituximab biosimilar) / Fosun Pharma, Eurofarma, Farma de Colombia, Abbott
2020-000736-21: A Phase 3 study to evaluate the efficacy and safety of HLX01 versus rituximab (Mabthera®) as treatment for patients with low tumour burden follicular lymphoma.

Not yet recruiting
3
212
Europe
Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody Injection, Mabthera®, HLX01, Concentrate for solution for infusion, Mabthera®
Shanghai Henlius Biotech Inc., Shanghai Henlius Biotech, Inc.
Low tumour burden follicular lymphoma, Disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes., Diseases [C] - Blood and lymphatic diseases [C15]
 
 
ChiCTR2000034167: A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined with MTX Therapy in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Recruiting
3
267
 
During the 24-week study, subjects will be given one course of treatment with HLX01, After the Week 24 study visit, all subjects will continue to be given one course of treatment with HLX01 ;During the 24-week study, subjects will be given one course of treatment with placebo. After the Week 24 study visit, all subjects will continue to be given one course of treatment with HLX01
Chinese Academy of Medical Sciences Peking Union Medical College; Shanghai Henlius Biotech, Inc., Shanghai Henlius Biotech, Inc.
Rheumatoid Arthritis
 
 
RIPPLE, NCT04246359: Rituximab and Pegylated Interferon α-2b in Patients With Indolent B-cell Lymphoma

Recruiting
2
52
RoW
Rituximab Biosimilar, HLX01, Pegylated Interferon α-2b
Huiqiang Huang
Lymphoma, B-Cell
06/22
01/23
NCT07038382: A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis

Recruiting
2
24
RoW
HLX79 10mg/kg/Placebo+HLX01, HLX79 20mg/kg/Placebo + HLX01, HLX79 30mg/kg/placebo+HLX01
Shanghai Henlius Biotech
Membranous Nephropathy, Lupus Nephritis (LN)
01/27
05/30
ChiCTR2200064195: A clinical study of Hanlikang and BTK inhibitors in the treatment of newly diagnosed mantle cell lymphoma

Recruiting
1
100
 
R-BAP chemotherapy regimen and zanubrutinib ;R-BAP chemotherapy regimen and Ibrutinib
The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University, self-raised
mantle cell lymphoma
 
 
NCT05506410: A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma

Recruiting
N/A
100
RoW
Rituximab, Bendamustine, Cytarabine, Prednisone, BTK inhibitors
Zhengzhou University
Newly Diagnosed Mantle Cell Lymphoma
06/24
12/26
NCT04491721: Follow-up the OS and PFS of Rituximab Biosimilar HLX01 and MabThera, in Untreated Subjects With CD20+ DLBCL

Enrolling by invitation
N/A
407
RoW
Chinese Academy of Medical Sciences
Diffuse Large B Cell Lymphoma
06/27
07/27
HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
NCT04155125: A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient

Completed
3
391
RoW
efepoetin alfa, Mircera
PT Kalbe Genexine Biologics, Novotech (Australia) Pty Limited
Anaemia Associated With Chronic Kidney Disease
03/22
06/23
NCT06466785: A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

Recruiting
3
429
RoW
Efepoetin Alfa, GX-E4, Darbepoetin Alfa, Aranesp®
Genexine, Inc., PT Kalbe Genexine Biologics
Anemia of Chronic Kidney Disease
12/26
09/27
GX-E4-HV-003, NCT06490939: Clinical Trial of Efepoetin Alfa in Healthy Subjects

Recruiting
1
40
RoW
Efepoetin Alfa, GX-E4
Genexine, Inc.
Healthy
02/25
10/25
Hercessi (trastuzumab-strf) / Fosun Pharma, Intas, Eurofarma
ChiCTR2100043780: Real world study of trastuzumab (Zercepac) in the treatment of HER2 positive advanced gastric carcer

Recruiting
4
500
 
Zercepac
Jiangsu Province Cancer Hospital; School of Public Health, Peking University, Henlius
advanced gastric carcer
 
 
ChiCTR2100043781: Real world study of trastuzumab(Zercepac) in the treatment of HER2 positive breast cancer

Recruiting
4
9500
 
Zercepac
Jiangsu Province Cancer Hospital; School of Public Health, Peking University, Henlius
Breast cancer
 
 
 

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