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
- -
Molecularly Target Therapy With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
- First Posted Date
- 2016-07-19
- Last Posted Date
- 2018-05-07
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Target Recruit Count
- 152
- Registration Number
- NCT02836847
- Locations
- 🇨🇳
Xinhua Hospital, Shanghai, Shanghai, China
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
- Conditions
- Interventions
- Drug: AdavosertibDrug: RibociclibDrug: OlaparibDrug: VistusertibDrug: NivolumabDrug: EnasidenibDrug: FutibatinibDrug: FadraciclibDrug: CytarabineDrug: TopotecanDrug: EverolimusDrug: CarboplatinDrug: IrinotecanDrug: CyclophosphamideDrug: SelumetinibDrug: LirilumabDrug: CeralasertibDrug: CapmatinibDrug: TemozolomideDrug: Dexamethasone
- First Posted Date
- 2016-06-24
- Last Posted Date
- 2023-05-30
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Target Recruit Count
- 460
- Registration Number
- NCT02813135
- Locations
- 🇩🇰
Rigshospitalet, Copenhagen, Denmark
🇫🇷Gustave Roussy, Villejuif, Val De Marne, France
🇳🇱Erasmus MC, Sophia Children's Hospital, Rotterdam, Netherlands
Single-centre Study of Everolimus as GvHD Prophylaxis After Post-Transplantation Cyclophosphamide After Allogeneic SCT
- First Posted Date
- 2016-06-24
- Last Posted Date
- 2021-03-17
- Lead Sponsor
- University of Cologne
- Target Recruit Count
- 19
- Registration Number
- NCT02812940
- Locations
- 🇩🇪
University of Cologne, Cologne, Germany
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2016-06-23
- Last Posted Date
- 2024-11-01
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 1069
- Registration Number
- NCT02811861
- Locations
- 🇮🇱
Chaim Sheba Medical Center, Ramat-Gan, Israel
🇯🇵Facility #2, Tokyo, Japan
🇺🇸Mount Sinai Medical Center, Miami Beach, Florida, United States
Dried Blood SPOT Analysis of Everolimus in Cancer Patients (SPOT-study)
- Conditions
- First Posted Date
- 2016-06-22
- Last Posted Date
- 2017-10-16
- Lead Sponsor
- Radboud University Medical Center
- Target Recruit Count
- 75
- Registration Number
- NCT02809404
- Locations
- 🇳🇱
Radboud university medical center, Nijmegen, Netherlands
A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-04-18
- Last Posted Date
- 2021-09-23
- Target Recruit Count
- 40
- Registration Number
- NCT02742051
- Locations
- 🇨🇳
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University, Guangzhou, Guangdong, China
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
- Conditions
- Interventions
- First Posted Date
- 2016-04-08
- Last Posted Date
- 2021-05-05
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 104
- Registration Number
- NCT02732119
- Locations
- 🇺🇸
Florida Cancer Specialists FL Cancer Specialists, Fort Myers, Florida, United States
🇺🇸St. Luke's Cancer Institute Regulatory, Kansas City, Missouri, United States
🇺🇸Research Medical Center HCA Midwest Division, Kansas City, Missouri, United States
MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2016-03-31
- Last Posted Date
- 2021-11-19
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Target Recruit Count
- 96
- Registration Number
- NCT02724020
- Locations
- 🇮🇹
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna, Italy
🇮🇹Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Italy
🇫🇷Groupe Hospitalier Pitie-Salpetriere, Paris cedex 13, Paris, France
Treg Therapy in Subclinical Inflammation in Kidney Transplantation
- Conditions
- Interventions
- First Posted Date
- 2016-03-17
- Last Posted Date
- 2024-10-07
- Target Recruit Count
- 32
- Registration Number
- NCT02711826
- Locations
- 🇺🇸
University of California at San Francisco, San Francisco, California, United States
🇺🇸University of Alabama, Birmingham, Birmingham, Alabama, United States
🇺🇸University of Colorado Health Transplant Center - Anschutz, Aurora, Colorado, United States
Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin
- First Posted Date
- 2016-02-22
- Last Posted Date
- 2023-05-30
- Lead Sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- Target Recruit Count
- 30
- Registration Number
- NCT02687958
- Locations
- 🇮🇹
U.O. Oncologia Medica 1 - AOU Pisana, Pisa, Tuscany, Italy
🇮🇹S.C. Oncologia - Policlinico, Modena, Emilia - Romagna, Italy
🇮🇹Azienda Ospedaliera "Spedali Civili di Brescia", Brescia, Italy
Drug Development Updates
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