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
- -
IGF-1 Inhibitor Pasireotide Lar in Combination With the m-TOR Inhibitor Everolimus
- First Posted Date
- 2010-11-04
- Last Posted Date
- 2013-01-10
- Lead Sponsor
- Milton S. Hershey Medical Center
- Registration Number
- NCT01234974
- Locations
- 🇺🇸
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2010-11-01
- Last Posted Date
- 2021-03-26
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 72
- Registration Number
- NCT01231659
- Locations
- 🇮🇱
Novartis Investigative Site, Tel Aviv, Israel
Everolimus and Combination Chemotherapy in Treating Patients With Metastatic Stomach or Esophageal Cancer
- Conditions
- Interventions
- First Posted Date
- 2010-11-01
- Last Posted Date
- 2017-05-31
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 6
- Registration Number
- NCT01231399
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸South Pasadena Cancer Center, South Pasadena, California, United States
🇺🇸H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery
- First Posted Date
- 2010-10-28
- Last Posted Date
- 2022-08-04
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 150
- Registration Number
- NCT01229943
- Locations
- 🇺🇸
Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States
🇺🇸Kaiser Permanente-Redwood City, Redwood City, California, United States
🇺🇸Kalispell Medical Oncology, Kalispell, Montana, United States
Study of Everolimus (RAD001) in Combination With Lenalidomide
- Conditions
- Interventions
- First Posted Date
- 2010-10-11
- Last Posted Date
- 2022-01-27
- Lead Sponsor
- Emory University
- Target Recruit Count
- 44
- Registration Number
- NCT01218555
- Locations
- 🇺🇸
Grady Health System, Atlanta, Georgia, United States
🇺🇸Emory University Winship Cancer Institute, Atlanta, Georgia, United States
Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial
- Conditions
- Interventions
- First Posted Date
- 2010-10-08
- Last Posted Date
- 2024-06-25
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 180
- Registration Number
- NCT01217931
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
A Study of mTOR Inhibitor Everolimus (RAD001) in Association With Cisplatin and Radiotherapy for Locally Advanced Cervix Cancer
- First Posted Date
- 2010-10-08
- Last Posted Date
- 2015-04-03
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 14
- Registration Number
- NCT01217177
- Locations
- 🇧🇷
Novartis Investigative Site, Rio de Janeiro, Brazil
Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Rhabdomyosarcoma and Other Soft Tissue Sarcomas
- First Posted Date
- 2010-10-07
- Last Posted Date
- 2013-03-26
- Lead Sponsor
- Sidnei Epelman
- Target Recruit Count
- 20
- Registration Number
- NCT01216839
- Locations
- 🇧🇷
Casa de Saúde Santa Marcelina, Sao Paulo, SP, Brazil
Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma
- First Posted Date
- 2010-10-07
- Last Posted Date
- 2013-08-07
- Lead Sponsor
- Sidnei Epelman
- Target Recruit Count
- 20
- Registration Number
- NCT01216826
- Locations
- 🇧🇷
Hospital Santa Marcelina, Sao Paulo, SP, Brazil
First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2010-10-06
- Last Posted Date
- 2023-11-24
- Lead Sponsor
- Matthew Galsky
- Target Recruit Count
- 36
- Registration Number
- NCT01215136
- Locations
- 🇺🇸
Cancer Care Center of Southern Indiana, Bloomington, Indiana, United States
🇺🇸Metro Health Cancer Care, Wyoming, Michigan, United States
🇺🇸Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center, New York, New York, United States
Drug Development Updates
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