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
- -
Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial Meningioma
- First Posted Date
- 2009-09-04
- Last Posted Date
- 2021-11-10
- Lead Sponsor
- SCRI Development Innovations, LLC
- Target Recruit Count
- 18
- Registration Number
- NCT00972335
- Locations
- 🇺🇸
Nebraska Methodist Cancer Center, Omaha, Nebraska, United States
🇺🇸Peninsula Cancer Institute, Newport News, Virginia, United States
🇺🇸Norton Cancer Institute, Louisville, Kentucky, United States
Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency
- First Posted Date
- 2009-08-31
- Last Posted Date
- 2020-12-21
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 34
- Registration Number
- NCT00968591
- Locations
- 🇸🇬
Novartis Investigative Site, Singapore, Singapore
Panobinostat (LBH589) Plus Everolimus (RAD001) in Patients With Relapsed and Refractory Lymphoma
- First Posted Date
- 2009-08-27
- Last Posted Date
- 2015-02-26
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 31
- Registration Number
- NCT00967044
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients
- Conditions
- Interventions
- First Posted Date
- 2009-08-25
- Last Posted Date
- 2014-08-15
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 36
- Registration Number
- NCT00965094
- Locations
- 🇮🇱
Novartis Investigative Site, Tel-Aviv, Israel
Panobinostat and Everolimus in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
- Conditions
- First Posted Date
- 2009-08-20
- Last Posted Date
- 2013-02-15
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 11
- Registration Number
- NCT00962507
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸City of Hope Medical Group, Pasadena, California, United States
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
- First Posted Date
- 2009-08-07
- Last Posted Date
- 2018-08-24
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 15
- Registration Number
- NCT00954512
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
- First Posted Date
- 2009-07-31
- Last Posted Date
- 2017-01-12
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 38
- Registration Number
- NCT00949949
- Locations
- 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸Mayo Clinic, Rochester, Minnesota, United States
Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2009-07-22
- Last Posted Date
- 2016-05-25
- Target Recruit Count
- 30
- Registration Number
- NCT00943956
- Locations
- 🇫🇷
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, France
Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary
- Conditions
- Interventions
- First Posted Date
- 2009-07-10
- Last Posted Date
- 2017-03-21
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Target Recruit Count
- 46
- Registration Number
- NCT00936702
- Locations
- 🇺🇸
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
🇺🇸Cancer Center of Kansas-Independence, Independence, Kansas, United States
🇺🇸Memorial Hospital of South Bend, South Bend, Indiana, United States
Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- First Posted Date
- 2009-07-09
- Last Posted Date
- 2017-09-26
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 28
- Registration Number
- NCT00935792
- Locations
- 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic, Rochester, Minnesota, United States
Drug Development Updates
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