19 completed, 2 unknown, 1 active not recruiting, 1 recruiting. 24 Phase 3, 1 Phase 2.
By phase and status
Follow RAD001: new trials by email Literature Review of RAD001 trials Research Report on RAD001
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All 24 trials
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
Everolimus, Elacestrant, Placebo - Advanced Breast Cancer, ER-positive Breast Cancer | Phase 3 | Recruiting | 300 | 2024-12-05 | 2026-08-24 |
Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer
Trastuzumab, Pertuzumab, Nab paclitaxel - HER2+ Breast Cancer | Phase 3 | Unknown | 120 | 2021-01-01 | 2022-06-23 |
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
everolimus - Tuberous Sclerosis Complex | Phase 3 | Active not recruiting | 206 | 2017-08-23 | 2026-08-21 |
A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
RAD001, Placebo, Antiepileptic drug (1 to 3 only) - Tuberous Sclerosis Complex-associated Refractory Seizures | Phase 3 | Completed | 366 | 2013-04-29 | 2018-11-07 |
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
everolimus, exemestane - Post Menopausal Breast Cancer | Phase 3 | Completed | 235 | 2013-03-29 | 2020-04-07 |
Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis Complex
Everolimus, Placebo - Tuberous Sclerosis Complex, TSC Related Cognitive Disability | Phase 2 / Phase 3 | Unknown | 60 | 2012-11-01 | 2015-05-05 |
Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients
RAD001, MMF - Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant | Phase 3 | Completed | 106 | 2012-08-17 | 2019-05-31 |
Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)
Everolimus, Placebo, Best suportive care (BSC) - Advanced NET of GI Origin, Advanced NET of Lung Origin | Phase 3 | Completed | 302 | 2012-03-30 | 2021-08-05 |
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients
standard therapy, Everolimus - Lung Transplantation | Phase 3 | Completed | 130 | 2012-02-01 | 2019-03-14 |
A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy
Paclitaxel, RAD001 - Advanced Gastric Cancer, Esophagogastric Junction Cancer | Phase 3 | Completed | 300 | 2011-10-01 | 2020-01-29 |
Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy
Bevacizumab, Everolimus, Laboratory Biomarker Analysis - Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma | Phase 3 | Terminated | 77 | 2010-09-15 | 2019-03-06 |
Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.
Everolimus, Everolimus Placebo, Best Supportive Care (BSC) - Carcinoma | Phase 3 | Completed | 546 | 2010-04-01 | 2016-09-22 |
Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
everolimus, Placebo, vinorelbine - HER2/Neu Over-expressing Locally Advanced Breast Cancer, Metastatic Breast Cancer | Phase 3 | Completed | 569 | 2009-10-01 | 2017-04-05 |
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
Everolimus, Placebo, Trastuzumab - Breast Cancer | Phase 3 | Completed | 719 | 2009-09-10 | 2018-12-19 |
Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mesenchymal Transition (EMT) and Immunosuppressive Regimen (Everolimus Based Versus CNI Based) in de Novo Renal Transplant Recipients
Certican®, Neoral, Myfortic - Renal Interstitial Fibrosis | Phase 3 | Completed | 194 | 2009-09-01 | 2014-03-18 |
Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)
Everolimus, Placebo - Tuberous Sclerosis, Subependymal Giant Cell Astrocytoma | Phase 3 | Completed | 117 | 2009-08-01 | 2016-02-03 |
Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy
Everolimus, Everolimus Placebo - Diffuse Large B-cell Lymphoma | Phase 3 | Completed | 742 | 2009-07-24 | 2017-07-12 |
Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
Everolimus, Everolimus placebo, Best Supportive Care (BSC) - Advanced Gastric Cancer | Phase 3 | Completed | 656 | 2009-07-01 | 2015-11-03 |
Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole
Everolimus, Exemestane, Everolimus Placebo - Breast Cancer | Phase 3 | Completed | 724 | 2009-06-03 | 2017-05-02 |
Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
Everolimus (RAD001), Everolimus Placebo - Tuberous Sclerosis Complex (TSC), Lymphangioleiomyomatosis (LAM) | Phase 3 | Completed | 118 | 2009-04-01 | 2017-02-17 |
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Conditions studied
Breast Neoplasms (4) · Tuberous Sclerosis (4) · Astrocytoma (2) · Carcinoma (2) · Carcinoma, Renal Cell (2) · Seizures (2) · Stomach Neoplasms (2) · Angiomyolipoma (1) · Autistic Disorder (1) · Carcinoid Tumor (1) · Carcinoma, Hepatocellular (1) · Death (1) · Digestive System Neoplasms (1) · Hematologic Neoplasms (1) · Hereditary Sensory and Autonomic Neuropathies (1)
Sponsors
Novartis Pharmaceuticals (19) · Erasmus Medical Center (1) · First Affiliated Hospital Xi'an Jiaotong University (1) · Krankenhaus Nordwest (1) · MedSIR (1) · National Cancer Institute (NCI) (1)
Countries
Germany (18) · Italy (16) · United States (16) · France (15) · Spain (14) · Canada (13) · United Kingdom (13) · Australia (12) · Japan (12) · Belgium (11) · Netherlands (10) · Poland (10) · South Korea (10) · Thailand (10) · Greece (9)
Top investigators
Antonio Llombart-Cussac, M.D., Ph.D. (1) · George Philips (1) · Jin Yang, Doctor (1) · Salah-Eddin Al-Batran, MD (1)
Results publications
PMID 25682485, PMID 29023494, PMID 30053159, PMID 33560090, PMID 18653228, PMID 19497063, PMID 19790150, PMID 20194812, PMID 21306238, PMID 22119496, PMID 22149876, PMID 22209391, PMID 22297244, PMID 22342553, PMID 22824201, PMID 23158522, PMID 23187897, PMID 23219086, PMID 23404211, PMID 23733802, PMID 23962028, PMID 24043745, PMID 24158787, PMID 24615500, PMID 24729041, PMID 24742739, PMID 25058218, PMID 25231953, PMID 25456370, PMID 25479584, PMID 26092818, PMID 26156073, PMID 26503204, PMID 26703889, PMID 26858193, PMID 26861602, PMID 27130844, PMID 27351628, PMID 27532364, PMID 27613521, PMID 27621394, PMID 28113028, PMID 28399902, PMID 28444114, PMID 28838862, PMID 29055056, PMID 29081664, PMID 29253068, PMID 29522361, PMID 30169322
NIH funding
2008 (6), 2009 (2), U10CA031946 (1), U10CA180821 (1)