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
- -
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
- Conditions
- Interventions
- First Posted Date
- 2013-02-05
- Last Posted Date
- 2021-02-26
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 309
- Registration Number
- NCT01783444
- Locations
- 🇺🇸
University of California at Los Angeles Mattel Children's Hospital, Los Angeles, California, United States
🇺🇸Sharp Memorial Hospital SharpClinicalOncologyResearch, San Diego, California, United States
🇺🇸Oncology Hematology Care Inc Oncology Hematology Care 2, Cincinnati, Ohio, United States
Phase 1b/2 Trial Using Lapatinib, Everolimus and Capecitabine for Treatment of HER-2 Positive Breast Cancer With CNS Metastasis
- First Posted Date
- 2013-02-05
- Last Posted Date
- 2019-11-12
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Target Recruit Count
- 9
- Registration Number
- NCT01783756
- Locations
- 🇺🇸
Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Pharmacokinetic of Everolimus and Atorvastatin Co-administration
- Conditions
- Interventions
- First Posted Date
- 2013-01-31
- Last Posted Date
- 2013-02-08
- Lead Sponsor
- Chulalongkorn University
- Target Recruit Count
- 18
- Registration Number
- NCT01780948
- Locations
- 🇹🇭
King Chulalongkorn Memorial Hospital, Bangkok, Thailand
Everolimus Beyond Progress for Patients Who Had Progress Under Everolimus and Exemestane
- Conditions
- Interventions
- First Posted Date
- 2013-01-23
- Last Posted Date
- 2016-02-10
- Lead Sponsor
- German Breast Group
- Target Recruit Count
- 3
- Registration Number
- NCT01773460
- Locations
- 🇩🇪
Klinikum Offenbach, Offenbach, Hessen, Germany
PNOC 001: Phase II Study of Everolimus for Recurrent or Progressive Low-grade Gliomas in Children
- Conditions
- Interventions
- First Posted Date
- 2012-11-27
- Last Posted Date
- 2024-10-09
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 65
- Registration Number
- NCT01734512
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Nationwide Children's Hospital, Columbus, Ohio, United States
🇺🇸The Children's Hospital Of Philadelphia, Philadelphia, Pennsylvania, United States
Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis Complex
- First Posted Date
- 2012-11-21
- Last Posted Date
- 2015-05-05
- Lead Sponsor
- Erasmus Medical Center
- Target Recruit Count
- 60
- Registration Number
- NCT01730209
- Locations
- 🇳🇱
Erasmus Medical Center, Rotterdam, Netherlands
Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus
- Conditions
- Interventions
- First Posted Date
- 2012-10-29
- Last Posted Date
- 2016-08-19
- Target Recruit Count
- 25
- Registration Number
- NCT01715935
- Locations
- 🇫🇷
CHRU Besançon, Besançon, France
🇫🇷Hôpital Henri Mondor, Créteil, France
🇫🇷Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France
Dose Escalation Study Investigating Everolimus and Dovitinib in Metastatic Clear Cell Renal Cancer
- Conditions
- Interventions
- First Posted Date
- 2012-10-26
- Last Posted Date
- 2013-11-13
- Lead Sponsor
- Queen Mary University of London
- Target Recruit Count
- 17
- Registration Number
- NCT01714765
- Locations
- 🇬🇧
Barts Health NHS Trust, London, United Kingdom
Study of Everolimus, Pemetrexed, Carboplatin, and Bevacizumab to Treat Stage IV Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2012-10-04
- Last Posted Date
- 2014-11-24
- Target Recruit Count
- 13
- Registration Number
- NCT01700400
- Locations
- 🇺🇸
University of Arizona Cancer Center, Tuscon, Arizona, United States
🇺🇸University of Kentucky Markey Cancer Center, Lexington, Kentucky, United States
🇺🇸Providence Cancer Center, Portland, Oregon, United States
Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
- First Posted Date
- 2012-10-03
- Last Posted Date
- 2023-05-03
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 202
- Registration Number
- NCT01698918
- Locations
- 🇺🇸
Breastlink Medical Group Dept. of BreastlinkResearchGrp, Long Beach, California, United States
🇺🇸Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸University of Alabama Comprehensive Cancer Center SC-2, Birmingham, Alabama, United States
Drug Development Updates
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