everolimus / Generic mfg.  >>  Phase 3
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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
everolimus / Generic mfg.
NCT00856466: Extension Study to CRAD001A1202

Active, not recruiting
3
110
Japan
everolimus, mycophenolate mofetil
Novartis
Renal Transplant
12/12
 
2009-012436-32: Immunomonitoring by virus-specific T cells and evaluation as a prognostic marker for virus-induced diseases after kidney transplantation

Ongoing
3
64
Europe
Sandimmun Optoral 10 mg Weichkapseln, Sandimmun Optoral 25 mg Weichkapseln, Sandimmun Optoral 50 mg Weichkapseln, Sandimmun Optoral 100 mg Weichkapseln, Sandimmun® Optoral 100 mg/ml Lösung zum Einnehmen, Certican 0,1 mg Tabletten zur Herstellung einer Suspension zum Einnehmen, Certican 0,25 mg Tabletten zur Herstellung einer Suspension zum Einnehmen, Sandimmun Optoral 10 mg Weichkapseln, Sandimmun Optoral 25 mg Weichkapseln, Sandimmun Optoral 50 mg Weichkapseln, Sandimmun Optoral 100 mg Weichkapseln, Sandimmun® Optoral 100 mg/ml Lösung zum Einnehmen, Certican 0,1 mg Tabletten zur Herstellung einer Suspension zum Einnehmen, Certican 0,25 mg Tabletten zur Herstellung einer Suspension zum Einnehmen
Medizinische Hochschule Hannover
After solid organ transplantation immunosuppressive treatment disrupts the individual balance between virus-replication and cellular immune response. This can lead to an elevated risk of severe viral complications.1) Immunosuppressive therapy might better be steered by measuring of virus-specific T cells than by blood levels of immunosuppressants solely.2) The antiviral treatment should be restricted to patients with high risk of viral diseases (high costs, severe side effects).
 
 
2005-000380-26: A 12 month, multicenter, randomized, parallel, open-label study, to evaluate renal function and efficacy of Certican® (everolimus) with Simulect® (basiliximab) and cyclosporine discontinuation at 3 month post-transplant vs minimization, in de novo kidney transplant recipients

Ongoing
3
168
Europe
Certican®, RAD001, Certican®, Certican®
Novartis Farmacéutica S.A.
Renal Transplant
 
 
2005-004908-36: Extension E-03 al Protocolo nº RAD001AB253Estudio de seguimiento de 2 años para obtener datos especificos de la evolución de los pacientes de novo trasplantados cardíacos que discontinuaron la medicación de estudio de forma precoz en el estudio RAD001AB253Extension E-03 to Protocol No. RAD001A B253Tiene también en cuenta la Enmienda nº1 al Protocolo RAD001B253E3

Ongoing
3
332
Europe
Certican®, Imurel®, Certican®, Imurel®
Novartis Farmaceútica S.A
Trasplante cardiaco de novo
 
 
2008-000102-36: Immunosoppressive protocol based on everolimus and calcineurin inhibitor low doses in lung transplant recipients with moderate-severe kidney disease after standard immnuotherapy.

Ongoing
3
20
Europe
CERTICAN, CERTICAN
OSPEDALE POLICLINICO S. MATTEO
kidney disease after pulmonary transplant
 
 
2007-006221-27: Immunosuppression without calcineurin inhibitors and with the use of everolimus (Certican) in HCV-infected liver transplant patients

Ongoing
3
50
Europe
CERTICAN*60CPR 0,75MG, PROGRAF*60CPS 1MG, CERTICAN*60CPR 0,75MG, PROGRAF*60CPS 1MG
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
HCV cirrhosis
 
 
2012-004856-12: Changes in the immune status (information on the status of the immune system)bei nierentransplantierten Patienten after switch to the immunosuppressive (suppression of immunological processes) therapy on the mTOR inhibitor everolimus (medication which prevent rejection following organ transplantation). An open-label (knowledge of the assigned treatment), non-randomized (no random allocation to treatment groups), single center (contacted in one study center) study. Veränderungen des Immunstatus (Zustand des Immunsystems) bei nierentransplantierten Patienten nach Umstellung der immunsuppressiven (Unterdrückung immunologischer Prozesse) Therapie auf den mTOR Inhibitor Everolimus (Medikament, dass die Abstossungsreaktion nach Organtransplantation verhindern soll). Eine nicht-verblindete (Wissen um die zugeteilte Therapie), nicht-randomisierte (keine zufällige Zuteilung zu den Behandlungsgruppen), monozentrische (in einem Studienzentrum durchgeführt) Studie.

Ongoing
3
40
Europe
Certican, Tacrolimus Sandoz, Certican 0,25mg Tabletten, Tacrolimus Sandoz 0,5mg Hartkapseln, Certican 0,5mg Tabletten, Certican 0,75mg Tabletten, Certican 1 mg Tabletten, Tacrolimus Sandoz 1mg Hartkapseln, Tacrolimus Sandoz 5mg Hartkapseln, Certican 0,25mg Tabletten, Tacrolimus Sandoz 0,5mg Hartkapseln, Certican 0,5mg Tabletten, Certican 0,75mg Tabletten, Certican 1 mg Tabletten, Tacrolimus Sandoz 1mg Hartkapseln, Tacrolimus Sandoz 5mg Hartkapseln
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie, Medizinische Universität Graz
organ transplant
 
 
2010-018353-36: BeTACTIC Study. Best Therapy After Cardiac Transplantation, the Italian Challenge. A multicenter, prospective, randomized, open-label study to compare the efficacy and safety of Everolimus and Mycophenolate (either mofetil or sodium) in association with Cyclosporine in patients with acute multiple/late rejection, cardiac allograft vasculopathy, renal dysfunction after cardiac transplantation

Ongoing
3
400
Europe
CERTICAN, CELLCEPT, MYFORTIC, CERTICAN, CELLCEPT, MYFORTIC
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA, GRANDA (A.O. DI RILIEVO NAZIONALE)
Paitents will be enrolled at least one year after heart transplant
 
 
REACH3, NCT03112603 / 2016-004432-38: A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation

Checkmark Data from REACH3 trial for acute GVHD at ASH 2020
Dec 2020 - Dec 2020: Data from REACH3 trial for acute GVHD at ASH 2020
Checkmark Data from REACH3 trial in steroid-refractory chronic GVHD
Jul 2020 - Jul 2020: Data from REACH3 trial in steroid-refractory chronic GVHD
Completed
3
330
Europe, Canada, Japan, US, RoW
Ruxolitinib, Jakafi, INCB018424, Extracorporeal photopheresis (ECP), Low-dose methotrexate (MTX), Mycophenolate mofetil (MMF), mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus), Infliximab, Rituximab, Pentostatin, Imatinib, Ibrutinib
Incyte Corporation
Graft-versus-host Disease (GVHD)
05/20
12/22
UNIRAD, NCT01805271 / 2012-003187-44: Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy

Active, not recruiting
3
1278
Europe
Everolimus, Afinitor, Placebo
UNICANCER, Ministry of Health, France
Primary Non-metastatic Breast Cancer, Who Remain Disease-free
06/20
06/30
NCT04258423: Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function

Terminated
3
4
US
Tacrolimus, Prograf, Everolimus, Zortress
Indiana University
Kidney Failure
06/20
06/20
NCT04063865: Everolimus Monotherapy as Immunosuppression After Liver Transplant

Terminated
3
14
US
Tacrolimus, Prograf, Everolimus, Zortress
Indiana University
Kidney Failure
07/20
07/20
CLEAR trial, NCT02811861 / 2016-000916-14: Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

Checkmark Presentation of data from CLEAR trial in advanced RCC at IKCS 2022
Nov 2022 - Nov 2022: Presentation of data from CLEAR trial in advanced RCC at IKCS 2022
Checkmark Data from CLEAR trial in combination with Lenvima for RCC at ESMO 2022
Sep 2022 - Sep 2022: Data from CLEAR trial in combination with Lenvima for RCC at ESMO 2022
Checkmark Data from CLEAR trial in combination with Lenvima for RCC at ASCO 2022
More
Active, not recruiting
3
1069
Europe, Canada, Japan, US, RoW
Lenvatinib, Everolimus, Pembrolizumab, Sunitinib
Eisai Inc., Merck Sharp & Dohme LLC
Renal Cell Carcinoma
08/20
07/24
CONCEPT study, NCT03095040: CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma

Active, not recruiting
3
390
RoW
CM082 combined with everolimus, X-82, Affinitor, CM082, Everolimus
AnewPharma
Renal Cell Cancer Metastatic
02/21
12/21
NCT01674140: S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

Active, not recruiting
3
1939
US
anastrozole, Arimidex, everolimus, Afinitor, exemestane, Aromasin, goserelin acetate, Zoladex, letrozole, Femara, leuprolide acetate, Lupron, tamoxifen citrate, nolvadex, placebo
SWOG Cancer Research Network, National Cancer Institute (NCI)
Breast Cancer
12/22
01/30
NCT03580239: Everolimus in Castrated Resistant Prostate Cancer(CRPC)Patients With PI3K-AKT-mTOR Signaling Pathway Deficiency

Not yet recruiting
3
120
RoW
Everolimus, Novartis Pharma Schweiz AG, Placebo
Tianjin Medical University Second Hospital, Tianjin Medical University General Hospital, Tianjin First Central Hospital, The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine，China
Prostate Cancer
01/23
12/23
TEAMMATE, NCT03386539: Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score

Active, not recruiting
3
211
US
Everolimus, Zortress, Tacrolimus, Prograf, Mycophenolate Mofetil, Cellcept
Boston Children's Hospital, Stanford University, United States Department of Defense
Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy, Heart Transplant Failure and Rejection, Post-transplant Lymphoproliferative Disorder, Heart Transplant Infection
04/23
01/24
2022-000507-12: A randomized, controlled, open-label study of RYZ101 compared with standard of care therapy in subjects with inoperable, advanced, SSTR+ well-differentiated GEP-NET that has progressed following 177Lu SSA therapy Ensayo aleatorizado, controlado y abierto de RYZ101 frente al tratamiento habitual en sujetos con tumores neuroendocrinos gastroenteropancreáticos bien diferenciados SSTR+, avanzados e inoperables, que hayan progresado tras tratamiento con 177Lu SSA.

Not yet recruiting
3
288
Europe
RYZ101, Sunitinib, RYZ101, Sunitinib, L01XE04, Solution for injection, Tablet, Capsule, hard, Powder and solvent for suspension for injection, Solution for injection in pre-filled syringe, Everolimus Zentiva 5mg Tabletten, Szunitinib Mylan 12,5 mg, Sandostatin® LAR®- Monatsdepot 30 mg powder and solvent for suspension for injection, SOMATULINE AUTOGEL 120 mg solution for injection in a pre-filled syringe, Szunitinib Sandoz 12,5 mg
RayzeBio, Inc., RayzeBio, Inc.
gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) Tumores neuroendocrinos gastroenteropancreáticos, gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) Tumores neuroendocrinos gastroenteropancreáticos, Diseases [C] - Cancer [C04]
 
 
EVEREST, NCT01120249: S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery

Hourglass Jan 2021 - Dec 2021 : From EVEREST trial for patients with renal cancer who have undergone surgery
Active, not recruiting
3
1545
US
everolimus, placebo
SWOG Cancer Research Network, National Cancer Institute (NCI)
Kidney Cancer
07/23
10/26
ENABLAR-2, NCT05065411: Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer

Terminated
3
5
US
Enobosarm & Abemaciclib Combo, VERU-024, Verzenio, non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant, exemestane, fulvestrant, exemestane plus everolimus
Veru Inc.
Metastatic Breast Cancer
10/23
01/24
IDUNN, NCT04629833 / 2019-001462-15: Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy

Recruiting
3
210
Europe
MC0518, BAT
medac GmbH
Steroid-refractory Acute Graft-versus-host Disease
12/25
12/27
ARTEST, NCT04869943 / 2021-002176-39: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer

Terminated
3
52
Europe, US, RoW
Enobosarm, VERU-024, Exemestane, Mestane
Veru Inc.
Metastatic Breast Cancer
01/24
01/24
NCT05429684: Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer

Recruiting
3
120
RoW
Trastuzumab, herceptin；Inetetamab, Pertuzumab, Perjeta, Nab paclitaxel, Abraxane, Pyrotinib, SHR-1258, Capecitabine, T-DM1, Trastuzumab Emtansine, Everolimus, RAD001, CDK4/6 inhibitor, Palbociclib；, AI, Letrozole, Anti-PD-1 monoclonal antibody, Sintilimab
First Affiliated Hospital Xi'an Jiaotong University
HER2+ Breast Cancer
02/24
02/24
COMPETE, NCT03049189 / 2016-001897-13: Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

Active, not recruiting
3
309
Europe, US, RoW
177Lu-edotreotide PRRT, 177Lu-DOTATOC, 177Lu-Edo, Everolimus, Afinitor, Amino-Acid Solution, Arginine-Lysine Solution
ITM Solucin GmbH, ABX CRO, PSI CRO
Neuroendocrine Tumors
12/24
12/29
ADELA, NCT06382948: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

Not yet recruiting
3
240
NA
Everolimus, Zortress, Votubia, RAD001, Certican, Afinitor, Elacestrant, ER-306323, RAD1901, Selective estrogen receptor degrader/selective estrogen receptor modulator (SERD/SERM) RAD1901, Placebo, Auxiliary Medicinal Product - Dexamethasone, Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues
MedSIR, Stemline Therapeutics, Inc.
Advanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, ESR1 Gene Mutation
09/27
04/28
COMPOSE, NCT04919226 / 2021-001086-20: Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) -

Recruiting
3
202
Europe, US, RoW
177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT, 177Lu-DOTATOC 177Lu-Edo, CAPTEM (Capecitabine and Temozolomide), Amino-Acid Solution, Arginine-Lysine Solution, Everolimus, FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
ITM Solucin GmbH
Neuroendocrine Tumors
06/27
09/27
ML43171, NCT05306340 / 2022-000199-20: A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)

Recruiting
3
320
Europe, Japan, US, RoW
Giredestrant, GDC-9545, RO7197597, RG6171, Exemestane, Fulvestrant, Tamoxifen, Everolimus, LHRH Agonist, Dexamethasone Mouth Rinse
Genentech, Inc.
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
10/24
03/26
ACTION-1, NCT05477576: Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Active, not recruiting
3
288
Europe, Canada, US, RoW
RYZ101, Everolimus 10 mg, Sunitinib 37.5 MG, Octreotide LAR 60 MG Injection, Lanreotide 120Mg Sa Susp Inj Syringe
RayzeBio, Inc.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors, Carcinoid, Carcinoid Tumor, Pancreatic NET
07/25
07/28
BCTOP-T-M03, NCT05954442: Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype

Recruiting
3
203
RoW
Everolimus, Afinitor, Investigator's Choice of Chemotherapy, ICC
Fudan University
Triple Negative Breast Cancer, Metastatic Breast Cancer, Mutation
08/25
08/26
LITESPARK-005, NCT04195750 / 2019-003444-72: A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

Active, not recruiting
3
736
Europe, Canada, Japan, US, RoW
Belzutifan, MK-6482, WELIREG™, Everolimus, Afinitor, Afinitor DISPERZ, Zortress
Merck Sharp & Dohme LLC
Carcinoma, Renal Cell
09/25
09/25
NCT06105632: A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment

Recruiting
3
510
Europe, Canada, Japan, US, RoW
PF-07220060 CDK4 inhibitor, Fulvestrant, Everolimus, Exemestane
Pfizer
Advanced or Metastatic Breast Cancer
12/25
12/28
NCT02962414 / 2016-002977-37: Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment

Active, not recruiting
3
206
Europe, Canada, Japan, US, RoW
everolimus, RAD001
Novartis Pharmaceuticals
Tuberous Sclerosis Complex
08/27
08/27
LEVEL, NCT05918302: Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

Recruiting
3
120
Europe
177Lu-edotreotide, Everolimus
Grupo Espanol de Tumores Neuroendocrinos, ITM Oncologics GmbH, MFAR
Neuroendocrine Tumors, Lung Neuroendocrine Neoplasm, Thymus Neoplasms
03/28
07/28
BIOMEDE 2, NCT05476939: Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0

Recruiting
3
409
Europe
Everolimus, VOTUBIA, AFINITOR, ONC201, Radiotherapy
Gustave Roussy, Cancer Campus, Grand Paris, Chimerix, Innovative Therapies For Children with Cancer Consortium
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
09/28
09/31
ACTRN12605000599673: RAD in the Treatment of Pulmonary Fibrosis

Active, not recruiting
2/3
120
 
Dr Monique Malouf, novartis
Pulmonary Fibrosis
 
 
NCT05833815: Addition of Everolimus to Standard of Care in Carcinoma Gallbladder

Recruiting
2/3
56
RoW
Everolimus 10 mg, CapOx/GemOx, Standard of care, Chemotherapy
Banaras Hindu University
Gallbladder Cancer
11/23
11/23
FRUSICA-2, NCT05522231: Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma

Recruiting
2/3
264
RoW
fruquintinib+sintilimab, HMPL-013 + IBI308, axitinib / everolimus, fruquintinib, HMPL-013
Hutchison Medipharma Limited
Advanced Renal Cell Carcinoma
11/24
03/25
STAPOVER, NCT03458221: Signal TrAnsduction Pathway Activity Analysis in OVarian cancER

Recruiting
2/3
148
Europe
Letrozole Oral Product, Bicalutamide Oral Product, Everolimus Oral Product, Itraconazole Oral Product
Gynaecologisch Oncologisch Centrum Zuid, Radboud University Medical Center, Erasmus Medical Center, Maastricht University Medical Center, InnoSIGN, Eurofins
Recurrent Ovarian Cancer, Signal Transduction Pathway Deregulation, Therapy-Associated Cancer
10/26
10/26

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