Everolimus
- Generic Name
- Everolimus
- Brand Names
- Afinitor, Votubia, Zortress
- Drug Type
- Small Molecule
- Chemical Formula
- C53H83NO14
- CAS Number
- 159351-69-6
- Unique Ingredient Identifier
- 9HW64Q8G6G
- Background
Everolimus is a derivative of Rapamycin (sirolimus), and works similarly to Rapamycin as an mTOR (mammalian target of rapamycin) inhibitor. It is currently used as an immunosuppressant to prevent rejection of organ transplants. In a similar fashion to other mTOR inhibitors Everolimus' effect is solely on the mTORC1 protein and not on the mTORC2 protein.
- Indication
Everolimus is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole.
Indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease.
Indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.
Indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.
Indicated in pediatric and adult patients with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.
- Associated Conditions
- Heart Transplant Rejection, Kidney Transplant Rejection, Liver Transplant Rejection, Progressive Neuroendocrine Tumors of pancreatic origin, Renal angiomyolipoma, tuberous sclerosis complex, Subependymal giant cell astrocytoma, tuberous sclerosis complex, Waldenstrom's Macroglobulinemia Refractory, Advanced Carcinoid tumor, Locally advanced Progressive Neuroendocrine Tumors of gastrointestinal origin, Locally advanced lung origin Progressive Neuroendocrine Tumors, Metastatic gastrointestinal origin Progressive Neuroendocrine Tumors, Metastatic lung origin Progressive Neuroendocrine Tumors, Refractory Advanced Renal Cell Carcinoma, Refractory, advanced Breast cancer, Unresectable gastrointestinal origin Progressive Neuroendocrine Tumors, Unresectable lung origin Progressive Neuroendocrine Tumors
- Associated Therapies
- -
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
- First Posted Date
- 2013-04-30
- Last Posted Date
- 2017-05-01
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 612
- Registration Number
- NCT01843348
- Locations
- 🇩🇪
Novartis Investigative Site, Tübingen, Germany
MPACT Study to Compare Effects of Targeted Drugs on Tumor Gene Variations
- Conditions
- Interventions
- First Posted Date
- 2013-04-09
- Last Posted Date
- 2023-09-29
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 208
- Registration Number
- NCT01827384
- Locations
- 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸National Cancer Institute Developmental Therapeutics Clinic, Bethesda, Maryland, United States
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
- Conditions
- Interventions
- First Posted Date
- 2013-03-06
- Last Posted Date
- 2024-04-10
- Lead Sponsor
- UNICANCER
- Target Recruit Count
- 1278
- Registration Number
- NCT01805271
- Locations
- 🇫🇷
Centre Leon Berard, Lyon, France
🇫🇷Gustave Roussy, Villejuif, France
Phase II Open Label, Non-randomized Study of Sorafenib and Everolimus in Relapsed and Non-resectable Osteosarcoma
- Conditions
- Interventions
- First Posted Date
- 2013-03-05
- Last Posted Date
- 2015-06-17
- Lead Sponsor
- Italian Sarcoma Group
- Target Recruit Count
- 38
- Registration Number
- NCT01804374
- Locations
- 🇮🇹
Fondazione del Piemonte per l'Oncologia IRCC Candiolo, Candiolo, Torino, Italy
Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI
- Conditions
- Interventions
- First Posted Date
- 2013-02-22
- Last Posted Date
- 2018-05-30
- Lead Sponsor
- PrECOG, LLC.
- Target Recruit Count
- 131
- Registration Number
- NCT01797120
- Locations
- 🇺🇸
Marin Cancer Care, Greenbrae, California, United States
🇺🇸SwedishAmerican Regional Cancer Center, Rockford, Illinois, United States
🇺🇸McFarland Clinic, PC, Ames, Iowa, United States
A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2013-02-22
- Last Posted Date
- 2024-10-24
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 62
- Registration Number
- NCT01797523
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸Memorial City Medical Center, Houston, Texas, United States
🇺🇸MD Anderson Cooper Cancer Center, Voorhees, New Jersey, United States
A Study Comparing AZD2014 vs Everolimus in Patients With Metastatic Renal Cancer
- Conditions
- Interventions
- First Posted Date
- 2013-02-15
- Last Posted Date
- 2014-06-24
- Lead Sponsor
- Queen Mary University of London
- Target Recruit Count
- 49
- Registration Number
- NCT01793636
- Locations
- 🇬🇧
Royal Sussex County Hospital, Brighton, United Kingdom
🇬🇧Royal Bournemouth Hospital, Bournemouth, United Kingdom
🇬🇧University Hospitals Coventry & Warwickshire NHS Trust, Coventry, United Kingdom
Everolimus Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Everolimus Study.
- First Posted Date
- 2013-02-12
- Last Posted Date
- 2021-06-11
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 34
- Registration Number
- NCT01789281
- Locations
- 🇺🇸
New York University Medical Center SC-4, New York, New York, United States
🇺🇸H Lee Moffitt Cancer Center and Research Institute SC-2, Tampa, Florida, United States
🇺🇸Rocky Mountain Cancer Centers SC, Greenwood Village, Colorado, United States
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Everolimus for Treating Patients With Pancreatic Neuroendocrine Tumors
- Conditions
- Interventions
- First Posted Date
- 2013-02-06
- Last Posted Date
- 2021-07-08
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 23
- Registration Number
- NCT01784861
- Locations
- 🇺🇸
Vanderbilt University, Nashville, Tennessee, United States
🇺🇸Washington University School of Medicine, Saint Louis, Missouri, United States
Efficacy Study of Sunitinib and Everolimus (Rotational vs Sequential Arm) in Pats. With m Clear Cell Renal Cancer
- Conditions
- Interventions
- First Posted Date
- 2013-02-06
- Last Posted Date
- 2017-10-02
- Lead Sponsor
- Associació per a la Recerca Oncologica, Spain
- Target Recruit Count
- 41
- Registration Number
- NCT01784978
- Locations
- 🇫🇷
Hopital Bordeaux University, Bordeaux, France
🇬🇷ALEXANDRA General Hospital of Athens, Athens, Greece
🇪🇸Hospital Marqués de Valdecilla, Santander, Cantabria, Spain
Drug Development Updates
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