Everolimus

Generic Name: Everolimus

Brand Names: Afinitor, Votubia, Zortress

Drug Type: Small Molecule

Chemical Formula: C_₅₃H_₈₃NO_₁₄

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: -

Clinical Trials

Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma

Phase 1

Completed

Conditions: Gastrin-Producing Neuroendocrine Tumor
Lung Carcinoid Tumor
Metastatic Digestive System Neuroendocrine Tumor G1
Pancreatic Glucagonoma
Pancreatic Insulinoma
Pancreatic Polypeptide Tumor
Paraganglioma
Recurrent Digestive System Neuroendocrine Tumor G1
Recurrent Merkel Cell Carcinoma
Recurrent Pancreatic Neuroendocrine Carcinoma

Interventions: Biological: Cixutumumab
Drug: Everolimus
Other: Laboratory Biomarker Analysis
Drug: Octreotide Acetate
Other: Pharmacological Study

First Posted Date: 2010-09-17

Last Posted Date: 2016-07-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 27

Registration Number: NCT01204476

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance

Phase 1

Completed

Conditions: Solid Tumors
Advanced Cancer

Interventions: Drug: Anastrozole
Drug: Bevacizumab
Drug: Sorafenib
Drug: Everolimus
Drug: Erlotinib

First Posted Date: 2010-09-09

Last Posted Date: 2021-01-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 277

Registration Number: NCT01197170

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy

Phase 3

Terminated

Conditions: Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v7
Stage III Renal Cell Cancer AJCC v7

Interventions: Biological: Bevacizumab
Drug: Everolimus
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

First Posted Date: 2010-09-09

Last Posted Date: 2019-03-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 77

Registration Number: NCT01198158

Locations: 🇺🇸
The Hospital of Central Connecticut, New Britain, Connecticut, United States
🇺🇸
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States
🇺🇸
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States

and more 515 locations

Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma

Phase 2

Terminated

Conditions: Kidney Cancer

Interventions: Drug: Everolimus
Drug: Sunitinib

First Posted Date: 2010-08-19

Last Posted Date: 2021-04-28

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 73

Registration Number: NCT01185366

Locations: 🇺🇸
Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Huntsman Cancer Institute - University of Utah, Salt Lake City, Utah, United States

and more 1 locations

Expanded Phase I Pazopanib and Everolimus in Advanced Solid Tumors and Previously Treated Advanced Urothelial Cancer

Phase 1

Completed

Conditions: Solid Tumor
Kidney Cancer

Interventions: Drug: pazopanib
Drug: everolimus

First Posted Date: 2010-08-18

Last Posted Date: 2019-10-02

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 23

Registration Number: NCT01184326

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States