Zejula (niraparib) / GSK, J&J 
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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Zejula (niraparib) / GSK, J&J
NCT06412120: Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

Not yet recruiting
4
70
US
Niraparib, GSK3985771
University of Miami, GlaxoSmithKline
Ovarian Cancer
09/27
09/29
POLO, NCT05187208: PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer

Not yet recruiting
4
102
NA
Niraparib
Seoul National University Hospital, Yonsei University, Asan Medical Center, Samsung Medical Center, Takeda
Epithelial Ovarian Cancer, Ovarian Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV
12/25
12/25
PRIMA, NCT02655016 / 2015-000952-11: A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Checkmark Results from PRIMA trial for 1L ovarian cancer at IGCS 2022
Sep 2022 - Sep 2022: Results from PRIMA trial for 1L ovarian cancer at IGCS 2022
Checkmark From PRIMA study in 1L platinum-responsive advanced ovarian cancer at ESMO 2022
Sep 2022 - Sep 2022: From PRIMA study in 1L platinum-responsive advanced ovarian cancer at ESMO 2022
Checkmark Top-line data from PRIMA trial for first line maintenance ovarian cancer
More
Active, not recruiting
3
733
Europe, Canada, US, RoW
Niraparib, Placebo
Tesaro, Inc., Gynecologic Oncology Group, European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetics, Inc.
Ovarian Neoplasms
05/19
09/24
NORA, NCT03705156: Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient

Checkmark Presentation of data from NORA trial in Chinese patients with platinum-sensitive recurrent ovarian cancer at ESMO 2022
Dec 2022 - Dec 2022: Presentation of data from NORA trial in Chinese patients with platinum-sensitive recurrent ovarian cancer at ESMO 2022
Active, not recruiting
3
265
RoW
ZL-2306(nirapairb), Placebos
Zai Lab (Shanghai) Co., Ltd.
Platinum-sensitive Relapsed Ovarian Cancer
02/20
08/24
MAGNITUDE, NCT03748641 / 2017-003364-12: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

Hourglass Jul 2022 - Sep 2022 : From MAGNITUDE trial in combination with Zytiga with or without HRR gene-mutated metastatic prostate cancer
Checkmark From MAGNITUDE trial in combination with Zytiga in metastatic prostate cancer at ASCO-GU 2022
Feb 2022 - Feb 2022: From MAGNITUDE trial in combination with Zytiga in metastatic prostate cancer at ASCO-GU 2022
Active, not recruiting
3
765
Europe, Canada, US, RoW
Niraparib, JNJ-64091742, Abiraterone Acetate, Prednisone, Placebo, New Formulation of Niraparib and Abiraterone Acetate (AA)
Janssen Research & Development, LLC
Castration-Resistant Prostatic Cancer
10/21
02/27
PRIME, NCT03709316: A Study of ZL-2306 (Niraparib) as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer

Checkmark From NORA trial for maintenance therapy in 2L ovarian cancer at ESMO 2020
Sep 2020 - Sep 2020: From NORA trial for maintenance therapy in 2L ovarian cancer at ESMO 2020
Checkmark From NORA study in Chinese patients with recurrent epithelial ovarian, fallopian tube/ primary peritoneal cancer
May 2020 - May 2020: From NORA study in Chinese patients with recurrent epithelial ovarian, fallopian tube/ primary peritoneal cancer
Checkmark Initiation of P3 trial for 1L ovarian cancer
More
Active, not recruiting
3
384
RoW
ZL-2306 (Nirapairb), Placebo Comparator
Zai Lab (Shanghai) Co., Ltd.
Ovarian Cancer
01/22
12/23
2021-001271-16: Evaluation of Niraparib alone compared to the combination of Niraparib and Bevacizumab in patients receiving chemotherapy for newly diagnosed advanced ovarian cancer

Not yet recruiting
3
970
Europe
Niraparib, Bevacizumab, Carboplatin, Paclitaxel, Capsule, hard, Concentrate for solution for infusion, Avastin, Carboplatin Kabi, Paclitaxel-GRY
AGO Research GmbH, GlaxoSmithKline Research & Development Limited
Patients with newly diagnosed, histologically confirmed, primary advanced invasive high grade epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer, FIGO stage III/IV (except FIGO IIIA2 without nodal involvement), with indication for a platin/paclitaxel chemotherapy, who have either undergone upfront primary surgery or plan to undergo chemotherapy with interval debulking surgery (IDS), Patients with newly diagnosed advanced ovarian cancer with indication for a platin/paclitaxel chemotherapy, who had a surgery for primary tumor or where surgery is planned after start of chemotherapy, Diseases [C] - Cancer [C04]
 
 
ANITA, NCT03598270 / 2018-000366-11: Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer

Active, not recruiting
3
414
Europe
Placebo, Placebo of Atezolizumab, Carboplatin, Paclitaxel, Niraparib, Gemcitabine, Pegylated liposomal doxorubicin (PLD), Atezolizumab, Tecentriq
Grupo Español de Investigación en Cáncer de Ovario, Hoffmann-La Roche, GlaxoSmithKline, AGO Study Group, Belgian Gynaecological Oncology Group, ARCAGY/ GINECO GROUP, Israeli Society of Gynecologic Oncology, MaNGO, Apices Soluciones S.L.
Recurrent Ovarian Carcinoma
01/24
01/24
ENGOT-0V44, NCT03602859 / 2018-000413-20: A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

Jul 2023 - Dec 2023: Data from FIRST trial in combination with Jemperli for 1L ovarian cancer
Checkmark Initiation of pivotal study
Jul 2018 - Jul 2018: Initiation of pivotal study
Active, not recruiting
3
1402
Europe, Canada, US, RoW
Niraparib, ZEJULA, Dostarlimab (TSR-042), Standard of care, Dostarlimab-Placebo, Niraparib-Placebo
Tesaro, Inc., European Network of Gynaecological Oncological Trial Groups (ENGOT)
Ovarian Neoplasms, Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
10/24
06/26
STAMPEDE2, NCT06320067: A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer

Not yet recruiting
3
8000
NA
Stereotactic Ablative Body Radiotherapy (SABR), Stereotactic body radiotherapy (SBRT), 177Lu-PSMA-617, Lutetium (177Lu) Vipivotide Tetraxetan, AAA617, Pluvicto, Niraparib and Abiraterone Acetate Dual Action Tablet DAT, Nira-AA, CJNJ-67652000-ZZZ, Abiraterone Acetate, Zytiga, Apalutamide, Erleada, JNJ-56021927, Androgen Deprivation Therapy (ADT), Androgen Receptor Signalling Inhibitor (ARSI), Local Radiotherapy, Prednisolone, Docetaxel
University College, London, Cancer Research UK, Novartis, Janssen Pharmaceutica NV
Prostate Cancer Metastatic
04/31
03/34
NCT06388733: A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Recruiting
3
450
US
Niraparib, Zejula, Temozolomide, Temodar, TMZ
Ivy Brain Tumor Center, GlaxoSmithKline
Glioblastoma, GBM, Brain Neoplasms, Adult, Malignant, Brain Tumor
12/27
03/28
AMPLITUDE, NCT04497844 / 2020-002209-25: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Hourglass Jul 2022 - Sep 2022 : From AMPLITUDE trial in combination with Zytiga for HRR gene-mutated metastatic prostate cancer
Active, not recruiting
3
696
Europe, Canada, US, RoW
Niraparib, Abiraterone acetate (AA), Prednisone, Placebo for Niraparib
Janssen Research & Development, LLC
Metastatic Castration-sensitive Prostate Cancer
11/24
05/27
ZEAL-1L, NCT04475939 / 2020-002202-20: Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer

Calendar Jan 2024 - Dec 2024: Data from ZEAL-1L trial in combination with Keytruda for 1L NSCLC
Active, not recruiting
3
666
Europe, US, RoW
Niraparib, Pembrolizumab, Placebo
GlaxoSmithKline
Lung Cancer, Non-Small Cell
12/24
02/25
NItCHE, NCT04679064 / 2020-000146-33: Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

Recruiting
3
427
Europe
Niraparib, Zejula, Dostarlimab, TSR-042, Pegylated liposomal doxorubicin, Paclitaxel, Gemcitabine, Topotecan, Bevacizumab, Avastin
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, GlaxoSmithKline
Ovarian Cancer
01/25
01/25
ZEST, NCT04915755 / 2020-003973-23: Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

Calendar Jan 2025 - Dec 2025: Pivotal data from ZEST trial for HER2-negative BRCA-mutated or triple-negative breast cancer
Active, not recruiting
3
40
Europe, Canada, Japan, US, RoW
Niraparib, Placebo
GlaxoSmithKline
Neoplasms, Breast
03/25
08/29
RUBY, NCT03981796 / 2019-001576-11: A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

Hourglass Jan 2024 - Jun 2024 : Submission in US for 1L endometrial cancer (based on RUBY part 2 trial)
Hourglass Nov 2022 - Dec 2022 : Interim analysis data from RUBY trial for 1L endometrial cancer
Checkmark Data from RUBY trial for 1L endometrial cancer
Dec 2022 - Dec 2022: Data from RUBY trial for 1L endometrial cancer
Hourglass Jan 2019 - Dec 2019 : Data readout from lymphoma cohort
Active, not recruiting
3
785
Europe, Canada, US, RoW
Dostarlimab, TSR-042, Placebo matching dostarlimab, Carboplatin, Paclitaxel, Niraparib, Placebo matching Niraparib
Tesaro, Inc., European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Neoplasms
09/22
11/26
ProBio, NCT03903835 / 2018-002350-78: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

Recruiting
3
750
Europe
Enzalutamide Oral Capsule, Xtandi, Abiraterone Oral Tablet, Zytiga, Carboplatin, Cabazitaxel 60 mg Solution for Injection, Docetaxel Injectable Solution, Radium Chloride Ra-223, Xofigo, Niraparib plus Abiraterone acetate plus Prednisone, Akeega, Capivasertib plus Docetaxel, Apalutamide, Erleada, Darolutamide, Nubeqa
Karolinska Institutet, The Swedish Research Council, Kom Op Tegen Kanker, Janssen Pharmaceutica N.V., Belgium, AstraZeneca, Cancerfonden
Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
12/26
12/26
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
IMbrella B, NCT03768063 / 2018-003352-20: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Recruiting
3
1000
Europe, Canada, Japan, US, RoW
Atezolizumab, Tecentriq, Bevacizumab, Avastin, Alectinib, Alecensa, Cobimetinib, Cotellic, Vemurafenib, Zelboraf, FAP IL2V, simlukafusp alfa, Venetoclax, Venclexta, Enzalutamide, Xtandi, Pembrolizumab, Keytruda, Sunitinib, Sutent, Niraparib, Zejula, Cabozantinib, Cometriq, Pemetrexed, Paclitaxel, Emactuzumab, Rucaparib
Hoffmann-La Roche, F. Hoffmann-La Roche Ltd, F. Hoffmann- La Roche Ltd
Cancer
07/28
07/28
HOTT, NCT05659381: Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer

Recruiting
3
230
US
Cisplatin, Platinol AQ, No treatment
GOG Foundation, GlaxoSmithKline
Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Stage III Primary Peritoneal Cancer, Stage IV Primary Peritoneal Cancer, Stage III Fallopian Tube Cancer, Stage IV Fallopian Tube Cancer
08/33
08/38
ROCSAN, NCT03651206: Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib

Hourglass Jan 2019 - Jan 2019 : Initiation of P2/3 ROCSAN trial for recurrent ovarian carcinosarcoma
Active, not recruiting
2/3
196
Europe
Niraparib, Niraparib + TSR-042 (Dostarlimab), Chemotherapy Drugs
ARCAGY/ GINECO GROUP, Tesaro, Inc.
Ovarian Carcinosarcoma, Endometrial Carcinosarcoma
12/24
06/25
2017-003353-41: Mesothelioma Stratified Therapy (MiST) - Including the following treatment arms: MiST 1 rucaparibMiST 2 abemaciclibMiST 3 pembrolizumab in combination with bemcentinibMiST 4 atezolizumab in combination with bevacizumabMiST 5 dostarlimab in combination with niraparib

Not yet recruiting
2
120
Europe
rucaparib, abemaciclib, Tecentriq, Avastin (for the 100mg/4ml presentation), Avastin (for 400 mg/16 ml presentation), Pembrolizumab, bemcentinib, KEYTRUDA (Pembrolizumab, MK3475), KEYTRUDA (pembrolizumab, MK3475), Niraparib, Dostarlimab, CO-338, LY2835219, R05541267/F03, RO4876646/F01, RO4876646/F02, MK-3475, BGB324, Tablet, Capsule, hard, Concentrate for solution for infusion, Solution for infusion, Capsule, Tecentriq, Avastin (for the 100mg/4ml presentation), Avastin (for 400 mg/16 ml presentation), KEYTRUDA (Pembrolizumab, MK3475), KEYTRUDA (pembrolizumab, MK3475), Niraparib
University of Leicester, The British Lung Foundation, Clovis Pharmaceuticals Inc., Eli Lilly & Company, Roche Pharma AG, Merck Sharp & Dohme Limited, BerGenBio ASA, GlaxoSmithKline Research & Development Limited
Malignant Mesothelioma (MM) - pleural and peritoneal, Mesothelioma is a universally lethal cancer caused by Asbestos. There has only been one licenced therapy since 2003. Accordingly there is a pressing need for effective therapy in the relapsed setting, Diseases [C] - Cancer [C04]
 
 
2018-004623-36: MEGALiT - a study in which the effect of established cancer drugs is investigated on new cancers that have a specific molecular signature MEGALiT - en studie där effekten av etablerade cancerläkemedel undersöks på nya cancersjukdomar som har en specifik molekylär signatur

Not yet recruiting
2
154
Europe
Tecentriq, Cotellic, Zejula, Everolimus, RO5514041/F04, Concentrate for solution for infusion, Film-coated tablet, Capsule, hard, Tablet, Tecentriq, Cotellic, Zejula
Uppsala University Hospital, Roche AB
In part 1 of the study: any solid tumor with the exemption of sarcoma. In part 2: any solid tumor or hematological malignancy, In part 1 of the study: any solid tumor with the exemption of sarcoma. In part 2: any solid tumor or hematological malignancy, Diseases [C] - Cancer [C04]
 
 
2017-004323-72: Clinical Trial to evaluate the efficacy and safety of Niraparib + Endocrin Therapy in luminal metastatic breast cancer patients. Ensayo clínico para evaluar la eficacia y seguridad de Niraparib + Terapia endocrina en pacientes luminales con cáncer de mama metastásico.

Not yet recruiting
2
23
Europe
Capsule, hard, Zejula
Medica Scientia Innovation Research (MedSIR), Tesaro,INC.
Advanced or metastatic HR-positive/HER2-negative breast cancer inpatients harboring either gBRCAms or gBRCAwt and HRD. Cáncer de mama avanzado o metastásico HR-positivo/HER2-negativo en pacientes con gBRCAms o gBRCAwt y HRD., Luminal advanced or metastatic breast cancer Cáncer de mama avanzado o metastásico en pacientes luminales, Diseases [C] - Cancer [C04]
 
 
2019-004771-40: ProTargetA Danish Nationwide Clinical Trial on Targeted Anti-Cancer Treatment based on Genomic Profiling

Not yet recruiting
2
300
Europe
Zejula, Capsule, hard, Concentrate and solvent for solution for infusion, Tablet, Concentrate for solution for infusion, Powder for concentrate for solution for infusion, Alcensa, Tecentriq, Cotellic, Zelboraf, Herceptin, Perjeta, Kadcyla, Erivedge, Bavencio, Inlyta, Zejula, pemazyre, Retsevmo
Rigshospitalet, Roche, Pfizer
Eligible patients will have an advanced malignant disease for which standard treatment options are no longer available or feasible and acceptable performance status and organ function. Patienter med fremskreden og/eller metastatisk solid tumor, som har oplevet progression under standardbehandling, eller som er intolerante over for standardbehandling, Patients with advanced cancer without curative therapeutic options Patienter med fremskreden kræft uden mulighed for kurativ behandling, Diseases [C] - Cancer [C04]
 
 
2019-004875-38: The induction and maintenance treatment with PARP inhibitor and immunotherapy in HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC) Trattamento di induzione e mantenimento con inibitore di PARP e immunoterapia nel carcinoma a cellule squamose della testa e del collo (HNSCC) HPV-negativo

Ongoing
2
49
Europe
niraparib, dostarlimab, [niraparib], [TSR-042 (also known as GSK4057190) and WBP-285], Capsule, hard, Solution for infusion, Zejula
Fondazione GONO, GLAXOSMITHKLINE LLC
HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC) Carcinoma a cellule squamose della testa e del collo (HNSCC) HPV-negativo, HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC) Carcinoma a cellule squamose della testa e del collo (HNSCC) HPV-negativo, Diseases [C] - Cancer [C04]
 
 
OVARIO, NCT03326193: A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Checkmark From OVARIO trial in combination with bevacizumab for advanced ovarian cancer
Jan 2020 - Jan 2020: From OVARIO trial in combination with bevacizumab for advanced ovarian cancer
Active, not recruiting
2
105
US
Niraparib, ZEJULA, Bevacizumab, Avastin
Tesaro, Inc.
Ovarian Neoplasms
12/20
05/24
NCT03016338: Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer

Active, not recruiting
2
51
Canada
Niraparib, MK4827, TSR-042, Dostarlimab
University Health Network, Toronto, Tesaro, Inc.
Endometrial Cancer
01/21
12/25
Galahad, NCT02854436 / 2016-002057-38: An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Checkmark From GALAHAD trial for mCPRC
Sep 2019 - Sep 2019: From GALAHAD trial for mCPRC
Completed
2
289
Europe, Canada, US, RoW
Niraparib, JNJ-64091742
Janssen Research & Development, LLC
Prostatic Neoplasms
01/21
08/23
2018-004207-39: Mirvetuximab Soravtansine in patients with high expression of folate receptor alpha in their tumor and recurrent ovarian cancer

Not yet recruiting
2
136
Europe
Mirvetuximab Soravtansine, Powder and solvent for concentrate for solution for infusion, Solution for infusion, Capsule, hard, Film-coated tablet, , Caelyx, Carboplatin Kabi, Paclitaxel-GRY®, Gemedac®, Zejula, Lynparza, Rubraca
AGO Research GmbH, ImmunoGen, Inc.
This trial evaluates the efficacy and safety of Mirvetuximab soravtansine (IMGN853) plus Carboplatin chemotherapy in FRα high patients with recurrent ovarian cancer who are eligible for platinum-based chemotherapy., Safety and efficacy for carboplatin with Mirvetuximab soravtansine (IMGN853) compared to carboplatin combination chemotherapy, Diseases [C] - Cancer [C04]
 
 
2020-002667-53: EXTENSION STUDY FOR PATIENTS WHO HAVE COMPLETED A PRIOR GLAXOSMITHKLINE/TESARO-SPONSORED NIRAPARIB STUDY AND ARE JUDGED BY THE INVESTIGATOR TO BENEFIT FROM CONTINUED TREATMENT WITH NIRAPARIB

Not yet recruiting
2
59
Europe
NIRAPARIB, GSK 3985771, MK-4827, Capsule, Film-coated tablet, Zejula 100mg hard capsules, Zejula 100 mg film-coated tablets
GlaxoSmithKline Research & Development Limited, GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT, GSK
advanced ovarian, breast, or prostate cancer, advanced ovarian, breast, or prostate cancer, Diseases [C] - Cancer [C04]
 
 
NCT04409002: Niraparib + Dostarlimab + RT in Pancreatic Cancer

Completed
2
18
US
Niraparib, Zejula, Dostarlimab, Radiation
Massachusetts General Hospital, Tesaro, Inc.
Pancreatic Cancer, Metastatic Pancreatic Cancer
01/22
02/22
NCT03925350: Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation

Recruiting
2
41
US
Niraparib
California Pacific Medical Center Research Institute, Tesaro, Inc., Vanderbilt-Ingram Cancer Center, Huntsman Cancer Institute
Metastatic Melanoma
02/22
02/23
2021-005392-39: OPAL Master ProtocolPhase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments and/or Combinations of Treatments in Participants with Ovarian Cancer (OPAL).OPAL-Supplement CCohort C: Open-Label Phase 2, Randomized, Controlled Multicenter Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants with Homologous Recombination-Deficient Stage III/IV Ovarian Cancer. Estudio en paraguas de múltiples cohortes en fase IB/II para evaluar la seguridad y la eficacia de nuevos tratamientos y/o combinaciones de tratamientos en participantes con cáncer de ovario (OPAL).Cohorte C: Estudio de fase II, abierto, aleatorizado, controlado y multicéntrico para comparar niraparib frente a quimioterapia doble con platino-taxano como tratamiento neoadyuvante en participantes con cáncer de ovario en estadio III/IV con deficiencia de recombinación homóloga.

Not yet recruiting
2
84
Europe
Niraparib, GSK3985771, Capsule, Zejula
GlaxoSmithKline, S.A., GlaxoSmithKline Research and Development Ltd., GlaxoSmithkline R&D Ltd.
Ovarian cancer Cáncer de ovario, Ovarian Cancer Cáncer de ovario, Diseases [C] - Cancer [C04]
 
 
NCT04217798: Efficacy and Safety of Niraparib Combined With Oral Etoposide in Platinum Resistant/Refractory Recurrent Ovarian Cancer

Recruiting
2
36
RoW
Niraparib, oral etoposide
Peking Union Medical College Hospital, Zai Lab (Shanghai) Co., Ltd.
Ovarian Cancer
03/22
06/22
COHORT-A, NCT05751629: Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer

Completed
2
41
US
Dostarlimab, TSR-042, Bevacizumab, Avastin, Niraparib, ZEJULA
Tesaro, Inc.
Ovarian Neoplasm
04/22
04/22
2021-003042-20: Study assessing the efficacy of niraparib as first line therapy with pancreatic cancer patient's Etude évaluant l'efficacité du niraparib en première ligne de traitement chez les patients atteints d'un cancer du pancréas

Not yet recruiting
2
28
Europe
Capsule, ZEJULA
Centre Léon Bérard, GlaxoSmithKline (GSK) Group Company
Patients with metastatic homologous repair-deficient pancreatic cancer Patients présentant un cancer du pancréas métastatique avec un déficit de la recombinaison homologue, Pancreatic cancer Cancer du pancréas, Diseases [C] - Cancer [C04]
 
 
NIRVANA-R, NCT04734665: Niraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor

Recruiting
2
44
RoW
Niraparib-Bevacizumab
Yonsei University, Takeda
Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor
03/23
03/24
NIRA-PANC, NCT03553004: Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (): a Phase 2 Trial

Active, not recruiting
2
18
US
Niraparib Treatment
University of Kansas Medical Center, Tesaro, Inc.
Pancreatic Cancer
04/23
02/25
STAR, NCT04068753: Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer

Recruiting
2
66
US
Niraparib, dostarlimab
University of Oklahoma, Tesaro, Inc.
Recurrent Cervix Cancer, Progressive Cervix Cancer
07/25
07/27
NCT04716686: Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

Recruiting
2
83
RoW
Niraparib
Shandong University, Sun Yat-sen University, Tongji Hospital, Women's Hospital School Of Medicine Zhejiang University, Zai Lab (Shanghai) Co., Ltd.
Endometrial Carcinoma, Serous Carcinoma
12/25
12/26
NCT03601923: Niraparib in Patients With Pancreatic Cancer

Active, not recruiting
2
32
US
Niraparib, Zejula
Dana-Farber Cancer Institute, Tesaro, Inc.
Pancreatic Cancer
09/24
02/25
MiST, NCT03654833: Mesothelioma Stratified Therapy () : A Multi-drug Phase II Trial in Malignant Mesothelioma

Active, not recruiting
2
186
Europe
Rucaparib, CO-338, Abemaciclib, LY2835219, pembrolizumab & bemcentinib, Keytruda; BGB324, Atezolizumab & Bevacizumab, MPDL3280A; Avastin, Dostarlimab and Niraparib, Zejula
University of Leicester, British Lung Foundation, Clovis Oncology, Inc., Eli Lilly and Company, Merck Sharp & Dohme LLC, BerGenBio ASA, Roche Pharma AG, University Hospitals, Leicester, The Christie NHS Foundation Trust, GlaxoSmithKline
Mesothelioma, Malignant
10/23
10/23
NCT03840967: A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma

Terminated
2
14
US
Niraparib, Zejula
Shadia Jalal, MD, GlaxoSmithKline, Indiana University School of Medicine
Esophageal Cancer, Gastric Cancer, Adenocarcinoma
11/22
02/23
QPT-ORE-004, NCT05335993: A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

Active, not recruiting
2
10
US
Oregovomab, MAb-B43.13, Monoclonal antibody B43.13, Niraparib, Zejula
CanariaBio Inc., Veristat, LLC
Recurrent Ovarian Cancer, Recurrent Epithelial Cancer of Ovary, Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer, Peritoneal Cancer, Recurrent Carcinoma of Ovary, Adenocarcinoma of Ovary
03/24
12/24
NCT06237205: Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency

Not yet recruiting
2
33
NA
Niraparib
Korea University Anam Hospital, Takeda, Korean Cancer Study Group
Efficacy
06/26
06/27
NCT05385068: A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi

Not yet recruiting
2
35
NA
Niraparib, Anlotinib
Peking Union Medical College Hospital, Zai Lab (Shanghai) Co., Ltd.
Epithelial Ovarian Cancer
03/24
09/24
ELEMENT, NCT06201234: Evaluating the Addition of Elacestrant (Oral SERD) to Niraparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer

Not yet recruiting
2
176
Europe
Niraparib + Elacestrant, Niraparib
German Breast Group, Stemline Therapeutics, Inc., GlaxoSmithKline
Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation, PALB2 Gene Mutation
03/28
03/28
KNIGHTS, NCT06212583: High-Risk Metachronous Oligometastatic Prostate Cancer Trial

Recruiting
2
88
US
niraparib/abiraterone acetate, Stereotactic ablative radiation therapy (SABR), Androgen deprivation therapy (ADT)
University of Maryland, Baltimore, Janssen Scientific Affairs, LLC
Prostate Cancer, Oligometastatic Disease
12/28
12/29
ProTarget, NCT04341181: - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling

Recruiting
2
300
Europe
Alectinib, Alecensa, Atezolizumab, Tecentriq, Avelumab, Bavencio, Axitinib, Inlyta, Erlotinib, Tarceva, Vemurafenib plus Cobimetinib (combination), Zelboraf plus Cotellic (combination), Trastuzumab plus Pertuzumab (combination), Herceptin plus Perjeta (combination), Trastuzumab emtansine, Kadcyla, Vismodegib, Erivedge, Niraparib, Zejula
Ulrik Lassen, Roche Pharma AG, Pfizer, GlaxoSmithKline
Cancer, Tumors, Neoplasms, Neoplasia
04/24
04/25
NCT04313504: Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

Active, not recruiting
2
23
US
Niraparib, ZEJULA, Dostarlimab, TSR-042
Trisha Wise-Draper, GlaxoSmithKline
Head and Neck Cancer
06/24
06/27
PAVO, NCT05169437: Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

Active, not recruiting
2
22
US
Niraparib, Zejula
Tempus AI, GlaxoSmithKline
Solid Tumor, Breast Tumor, Colon Tumor, Malignant, Lung Tumor, Urologic Cancer, Pancreatic Cancer, Melanoma, Metastatic Cancer, Locally Advanced Solid Tumor, Esophageal Cancer, Endometrial Cancer, Head and Neck Cancer
06/24
01/25
NCT04080284: Trial of Maintenance With Niraparib- Uterine Serous Carcinoma

Recruiting
2
45
US
Niraparib, ZEJULA
Northwell Health, Tesaro, Inc.
Endometrial Cancer, Papillary Serous Endometrial Carcinoma, Uterine Serous Carcinoma, Endometrial Carcinoma, Cancer of the Endometrium
07/24
07/26
NCT06365970: Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers

Not yet recruiting
2
20
US
Niraparib, Zejula, Dostarlimab, Jemperli
Ibrahim Halil Sahin, GlaxoSmithKline
MMR-D/MSI-H Colorectal Cancers
07/26
07/27
NCT04584255: Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

Recruiting
2
62
US
Niraparib, Zejula, Dostarlimab, TSR042
Dana-Farber Cancer Institute, Translational Breast Cancer Research Consortium, Johns Hopkins University, GlaxoSmithKline
Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Breast Cancer, HER2-negative Breast Cancer, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Deleterious PALB2 Gene Mutation
07/25
07/29
NCT06433219: Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

Not yet recruiting
2
60
Europe, US
Tuvusertib (M1774), M1774, VXc-400, VRT-1363004, substance code MSC2584415A, Niraparib, GSK3985771, MK-4827, Lartesertib (M4076), M4076, substance code MSC2585823A
EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany
Ovarian Cancer
01/28
01/28
NCT04030559: Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects

Recruiting
2
30
US
Niraparib, MK-4827, MK4827, Niraparib Tosylate Monohydrate, Zejula, Radical Prostatectomy, Prostatovesiculectomy
Marc Dall'Era, MD, National Cancer Institute (NCI), Janssen, LP
ATM Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation, CDK12 Gene Mutation, CHEK1 Gene Mutation, CHEK2 Gene Mutation, DNA Damage Response Gene Mutation, DNA Repair Gene Mutation, FANCA Gene Mutation, FANCD2 Gene Mutation, FANCL Gene Mutation, GEN1 Gene Mutation, NBN Gene Mutation, Prostate Carcinoma, RAD51 Gene Mutation, RAD51C Gene Mutation
08/24
02/25
NIPAVect, NCT03983993: Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

Active, not recruiting
2
40
US
Niraparib, MK-4827, Zejula, Panitumumab, ABX-EGF, Vectibix
Emory University, GlaxoSmithKline, National Institutes of Health (NIH), National Cancer Institute (NCI)
Advanced Microsatellite Stable Colorectal Carcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Microsatellite Stable, RAS Wild Type, Stage IV Colorectal Cancer AJCC v8, MSI-H Colorectal Cancer
10/24
10/24
NCT05126342: Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi

Not yet recruiting
2
100
NA
Niraparib, Zejula, Dostarlimab, TSR-042
AGO Research GmbH, GlaxoSmithKline
Recurrent Ovarian Cancer, Recurrent Fallopian Tube Cancer, Primary Peritoneal Cancer
11/24
11/26
NCT04992013: Niraparib in Tumors Metastatic to the CNS

Recruiting
2
20
US
Niraparib, Zejula
Massachusetts General Hospital, GlaxoSmithKline
Metastatic Cancer, Central Nervous System Cancer
12/24
12/26
HARMONY, NCT06392841: Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations

Not yet recruiting
2
64
NA
Androgen Deprivation Therapy (ADT), Niraparib/Abiraterone Acetate DAT, Akeega, Abiraterone Acetate, Zytiga, Prednisone, Rayos, Deltasone, Prednisone Intensol, Docetaxel, Docefrez, Taxotere
Qian Qin, UT Southwestern Comprehensive Cancer Center, Janssen, LP
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation, CHEK2 Gene Mutation, FANCA Gene Mutation, PALB2 Gene Mutation, RAD51B Gene Mutation, RAD54L Gene Mutation
04/27
04/28
RAISE, NCT05718323: Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC

Recruiting
2
44
Europe
Niraparib
ETOP IBCSG Partners Foundation, GlaxoSmithKline, Development Limited
SCLC,Extensive Stage, SLFN11-positive
05/25
10/25
OU-SCC-PI-4G, NCT05297864: PARP Inhibition for Gliomas (PI-4G or π4g)

Terminated
2
15
US
Niraparib
University of Oklahoma, GlaxoSmithKline
Recurrent Glioblastoma, Recurrent Astrocytoma, Recurrent Oligodendroglioma, Recurrent Glioma
11/23
02/24
NCT05065021: Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor

Recruiting
2
40
Canada
Niraparib, ZEJULA, Dostarlimab, Bevacizumab, Paclitaxel
University Health Network, Toronto, GlaxoSmithKline
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, High Grade Serous Cancer, High Grade Endometrioid Cancer
06/25
06/25
NCT05526989: Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma

Recruiting
2
25
US
Dostarlimab, Jemperli, Niraparib, Zejula
H. Lee Moffitt Cancer Center and Research Institute, GlaxoSmithKline
Penile Carcinoma
10/25
10/26
NCT05961124: Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer

Recruiting
2
40
Canada
Niraparib, Zejula
Sunnybrook Health Sciences Centre, GlaxoSmithKline
Ovarian Cancer, Stage III Ovarian Cancer, Stage IV Ovarian Cancer, High Grade Ovarian Serous Adenocarcinoma
09/25
09/27
NCT04641247: A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study

Active, not recruiting
2
26
Europe, Canada, US, RoW
Niraparib
GlaxoSmithKline
Ovarian Neoplasms, Breast Neoplasms
11/25
11/25
NCT04221503: Niraparib/TTFields in GBM

Active, not recruiting
2
30
US
Niraparib, ZEJULA, Optune, Tumor Treatment Fields (TTFields), Planned surgical resection, Tumor Resection
University of Pennsylvania, Tesaro, Inc., NovoCure Ltd.
Glioblastoma, Recurrent Glioblastoma, GBM
12/25
12/25
NCT04592237: Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer

Active, not recruiting
2
120
US
Cabazitaxel, Jevtana, RPR-116258A, Taxoid XRP6258, XRP-6258, Carboplatin, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo, Cetrelimab, JNJ 63723283, JNJ-63723283, JNJ63723283, WHO 10757, Niraparib, MK-4827, MK4827
M.D. Anderson Cancer Center, Janssen Pharmaceutica
Aggressive Variant Prostate Carcinoma, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Metastatic Prostate Neuroendocrine Carcinoma, Metastatic Prostate Small Cell Carcinoma, Stage IV Prostate Cancer AJCC v8
12/25
12/25
ARID1A, NCT05523440: Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With Mutation

Recruiting
2
92
US
Bevacizumab, Avastin, Niraparib, Zejula
University of Oklahoma, GlaxoSmithKline
Recurrent Endometrial Carcinoma, Recurrent Ovarian Carcinoma, ARID1A Gene Mutation
01/26
01/27
PARPi-PANC, NCT05442749: Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer

Recruiting
2
28
Europe
Niraparib
Centre Leon Berard, GlaxoSmithKline
Metastatic Pancreatic Cancer
01/26
09/26
GUNS, NCT04812366: Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

Recruiting
2
315
Canada, US
Apalutamide 60mg Tab, Abiraterone Acetate 250mg, Prednisone 5mg Tab, Docetaxel, Niraparib 100mg Oral Capsule, Atezolizumab
University of British Columbia, Janssen Inc., University Health Network, Toronto
Prostate Cancer
04/26
04/26
NCT05515575: A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA

Active, not recruiting
2
8
US
Niraparib
Memorial Sloan Kettering Cancer Center, GlaxoSmithKline
Sarcoma,Soft Tissue, Sarcoma Uterus
08/26
08/26
DRUP, NCT02925234 / 2015-004398-33: The Drug Rediscovery Protocol ( Trial)

Recruiting
2
1550
Europe
Panitumumab, Vectibix, Olaparib, Lynparza, Dabrafenib, Tafinlar, Nilotinib, Tasigna, Trametinib, Mekinist, Erlotinib, Tarceva, Trastuzumab and Pertuzumab (combination treatment), Herceptin + Perjeta, Vemurafenib and Cobimetinib (combination treatment), Zelboraf + Cotellic, Vismodegib, Erivedge, Regorafenib, Stivarga, Nivolumab, Opdivo, Afatinib, Giotrif, Dabrafenib and trametinib, Tafinlar and Mekinist, Ribociclib, Kisqali, Lenvatinib, Lenvima, Pembrolizumab, Keytruda, Durvalumab, MEDI4736, Rucaparib, Rubraca, Axitinib, Inlyta, Palbociclib, Ibrance, Crizotinib, Xalkori, Sunitinib, Sutent, Cabozantinib, Cabometyx, Abemaciclib, Verzenios, Alectinib, Alecensa, Atezolizumab and Bevacizumab, Tecentriq and Avastin, Ipilimumab and nivolumab, Yervoy and Opdivo, Entrectinib, Rozlytrek, Talazoparib, Talzenna, Dacomitinib, Vizimpro, Lorlatinib, Lorviqua, Erdafitinib, Balversa, Alpelisib, Piqray, Niraparib, Zejula, Pemigatinib, Pemazyre, Selpercatinib, Retsevmo, Tepotinib, Tepmetko
The Netherlands Cancer Institute, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Novartis, Roche Pharma AG, Merck Sharp & Dohme LLC, Boehringer Ingelheim, Ipsen, Eisai Inc., Pfizer, Clovis Oncology - Pharma and, Eli Lilly and Company, Janssen, LP, GlaxoSmithKline, Incyte Corporation, Dutch Cancer Society, Stelvio for Life
Cancer, Tumors, Neoplasm, Neoplasia
09/27
12/27
OPAL, NCT03574779: A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer

Hourglass Oct 2019 - Dec 2019 : Proof-of-concept data from OPAL trial in combination with dostarlimab and Avastin for 2L+ PROC ovarian cancer
Recruiting
1b/2
125
Europe, Canada, US
Niraparib, ZEJULA, TSR-042, Bevacizumab, Avastin, Carboplatin, Paclitaxel
Tesaro, Inc.
Ovarian Neoplasms
08/24
03/26
ATTACC, NCT04972110: Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors

Recruiting
1b/2
196
US
RP-3500 (camonsertib), niraparib, olaparib
Repare Therapeutics, Roche Pharma AG
Advanced Solid Tumor, Adult
03/25
12/25
CAPRICE, NCT05519670: A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr

Not yet recruiting
1b/2
72
NA
Niraparib Oral Product
Institut Paoli-Calmettes, GlaxoSmithKline
Breast Cancer
09/27
12/27
2017-004927-56: A Phase 1b/2 Trial of SRA737 in Combination with Niraparib in Subjects with Metastatic Castration-resistant Prostate Cancer (mCRPC)

Not yet recruiting
1/2
70
Europe
SRA737 capsules, Niraparib, SRA737, Capsule
Sierra Oncology, Inc., Sierra Oncology, Inc.
Histologically or cytologically confirmed adenocarcinoma of the prostate, Patients with metastatic castration-resistant prostate cancer, Diseases [C] - Cancer [C04]
 
 
2020-000825-18: Safety and efficacy study to evaluate AsiDNA in addition with Niraparib for treatment of relapsed platinum sensitive ovarian cancer already treated with Niraparib since at least 6 months

Ongoing
1/2
26
Europe
AsiDNA, Powder for solution for infusion
Gustave Roussy, Onxeo S.A.
Relapsed platinum sensitive ovarian cancer, Relapsed platinum sensitive ovarian cancer, Diseases [C] - Cancer [C04]
 
 
QUEST, NCT03431350 / 2017-003552-23: A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting
1/2
136
Europe, Canada, US, RoW
Niraparib 200 mg, Cetrelimab 240 mg, JNJ-63723283, Cetrelimab 480 mg, Abiraterone acetate 1000 mg, Prednisone 5 mg
Janssen Research & Development, LLC
Prostatic Neoplasms, Castration-Resistant
08/21
12/24
Parpvax, NCT03404960: Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy

Checkmark Data from PARPVAX trial in combination with Opdivo / Yervoy in advanced pancreatic cancer
Aug 2022 - Aug 2022: Data from PARPVAX trial in combination with Opdivo / Yervoy in advanced pancreatic cancer
Active, not recruiting
1/2
104
US
Niraparib + Nivolumab, Arm A, Niraparib + Ipilimumab, Arm B
University of Pennsylvania, Bristol-Myers Squibb, GlaxoSmithKline
Pancreatic Adenocarcinoma
04/22
06/26
NCT03221400: PEN-866 in Patients With Advanced Solid Malignancies

Recruiting
1/2
340
US
PEN-866 Sodium, fluorouracil, 5-Fluorouracil, 5-FU, Folinic acid, Leucovorin, Niraparib, Zejula
Tarveda Therapeutics
Carcinoma, Endometrial Adenocarcinoma, Neoplasms, Squamous Cell Carcinoma of the Anus, Adenocarcinoma of the Pancreas, Advanced Cancer, Solid Tumor, Solid Carcinoma, Squamous Cell Carcinoma of the Cervix, Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Vulva, Squamous Cell Carcinoma of the Penis, Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Small-cell Lung Cancer, Small Cell Lung Carcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Adenocarcinoma
01/23
06/23
ZN-c3-006, NCT05198804: A Study of ZN-c3 and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer

Active, not recruiting
1/2
117
Europe, US
ZN-c3, Niraparib
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Ovarian Cancer, Platinum-resistant Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
05/25
05/25
TRIO-US L-06 , NCT03830918: Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy

Recruiting
1/2
74
US
Atezolizumab, MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq, Niraparib, MK-4827, MK4827, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration, Temozolomide, CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ
Jonsson Comprehensive Cancer Center, Translational Research in Oncology-U.S, Tesaro, Inc.
Advanced Malignant Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
01/25
01/26
ONC-2022-001, NCT06258018: Niraparib and Temozolomide in Patients Glioblastoma

Not yet recruiting
1/2
86
Europe
Temodal, Temozolomide, Niraparib
Armando Santoro, MD, Istituto Clinico Humanitas, GlaxoSmithKline
Glioma, Malignant
12/26
09/27
NICARAGUA, NCT03425201 / 2017-004367-12: Niraparib in Combination With Cabozantinib (XL184) in Patients With Advanced Urothelial Cancer

Active, not recruiting
1/2
20
Europe
Niraparib plus Cabozantinib
Fundacion CRIS de Investigación para Vencer el Cáncer, Ipsen, GlaxoSmithKline, Apices Soluciones S.L.
Urothelial Cancer
04/24
04/24
LUNAAR, NCT06329830: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer

Not yet recruiting
1/2
30
US
177Lu-PSMA-617, Pluvicto, Niraparib abiraterone acetate, Akeega, Prednisone, Rayos, Prednisone Intensol, Deltasone
Rohan Garje, Janssen Scientific Affairs, LLC
Metastatic Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
07/26
07/28
TBCRC 050, NCT03368729: Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

Recruiting
1/2
40
US
Niraparib, formerly MK-4827, Trastuzumab
University of Alabama at Birmingham, Translational Breast Cancer Research Consortium, Tesaro, Inc., Susan G. Komen Breast Cancer Foundation, Breast Cancer Research Foundation of Alabama, VFoundation
Metastatic Breast Cancer, HER2 Positive Breast Carcinoma
11/24
12/24
MORPHEUS mUC, NCT03869190 / 2017-004634-28: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

Hourglass Jul 2020 - Dec 2020 : Initial safety and efficacy data from P1b/2 MORPHEUS trial for bladder cancer
Recruiting
1/2
645
Europe, US, RoW
Atezolizumab, Enfortumab Vedotin, Niraparib, Magrolimab (Hu5F9-G4), Tiragolumab, Sacituzumab Govitecan, Tocilizumab, Cisplatin, Gemcitabine
Hoffmann-La Roche, Gilead Sciences, Inc., GlaxoSmithKline plc, Seattle Genetics and Astellas
Urothelial Carcinoma, Bladder Cancer
12/24
11/27
TOPAZ, NCT04926324: A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers

Recruiting
1/2
38
US
Niraparib, Zejula, Dostarlimab, Jemperli, Short course radiation, IMRT, VMAT
Joseph Caster, Ph.D., M.D., GlaxoSmithKline
Rectal Neoplasms, Rectal Neoplasm Malignant
12/24
12/26
NCT06077877: A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors

Recruiting
1/2
135
Canada, US
GSK4524101, Niraparib
GlaxoSmithKline
Neoplasms
12/27
11/29
NCT05898399: Study of ART6043 in Advanced/Metastatic Solid Tumors Patients

Recruiting
1/2
240
US
ART6043, Olaparib, Niraparib
Artios Pharma Ltd
Advanced Solid Tumor, Metastatic Solid Tumor
05/26
12/26
ASCLEPIuS, NCT04194554: A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer

Recruiting
1/2
100
US
Niraparib, Leuprolide, Abiraterone Acetate, Stereotactic body radiotherapy (SBRT), Ultra-hypofractionated radiotherapy
University of Michigan Rogel Cancer Center, Janssen Scientific Affairs, LLC
Prostate Cancer
11/26
05/27
RADIAN, NCT05784012: Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma

Recruiting
1/2
34
Europe
Dostarlimab, Niraparib, cisplatin plus radiotherapy
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello, GlaxoSmithKline, MFAR
Head and Neck Squamous Cell Carcinoma
09/27
03/29
NCT03307785: Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042

Active, not recruiting
1
58
US
Niraparib, Zejula, TSR-042, Carboplatin-Paclitaxel, Bevacizumab, Avastin, TSR-022, Carboplatin-Pemetrexed, Carboplatin-Nab-Paclitaxel
Tesaro, Inc.
Neoplasms, Metastatic Cancer, Advanced Cancer, Solid Tumor, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Stage IIIB, Non Small Cell Lung Cancer
02/20
08/24
NCT04577833: A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

Active, not recruiting
1
136
Europe, US, RoW
Niraparib, Abiraterone Acetate (AA), Prednisone
Janssen Research & Development, LLC
Prostatic Neoplasms
10/21
12/25
TABLET, NCT03329001: Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule

Completed
1
236
US
Niraparib Tablet, Niraparib Capsule
Tesaro, Inc.
Neoplasms
12/21
06/23
NCT03891615: Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer

Recruiting
1
30
US
Niraparib, ZEJULA, Osimertinib, Tagrisso
Massachusetts General Hospital, Tesaro, Inc.
Lung Cancer
04/22
04/24
NCT03945721: A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients

Recruiting
1
20
US
Niraparib, Radiation Therapy
Massachusetts General Hospital, Tesaro, Inc.
Triple Negative Breast Cancer, Residual Disease
05/22
12/26
NCT04235101: Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors

Completed
1
32
Europe
SYD985 + Niraparib, (vic-)trastuzumab duocarmazine + Zejula
Byondis B.V.
Solid Tumor
04/23
04/23
 

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