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

Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

Phase 2

Conditions: Head and Neck Cancer

First Posted Date: 2010-05-06

Last Posted Date: 2013-08-12

Lead Sponsor: Leiden University Medical Center

Target Recruit Count: 42

Registration Number: NCT01118065

Locations: 🇳🇱
Leiden University Medical Center, Leiden, Netherlands

A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors

Phase 1

Terminated

Conditions: Neuroendocrine Tumors
Metastases, Neoplasm
Carcinoma, Non-small Cell Lung
Renal Cell Carcinoma

Interventions: Drug: LY2584702
Drug: Erlotinib
Drug: Everolimus

First Posted Date: 2010-05-04

Last Posted Date: 2019-02-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 29

Registration Number: NCT01115803

Locations: 🇫🇷
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Villejuif, France

Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients

Phase 3

Completed

Conditions: Kidney Transplantation

Interventions: Drug: Everolimus
Drug: Prograf or Neoral

First Posted Date: 2010-05-03

Last Posted Date: 2017-05-30

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 828

Registration Number: NCT01114529

Locations: 🇹🇷
Novartis Investigative Site, Istanbul, Turkey

Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma

Phase 2

Completed

Conditions: Advanced Non-clear Cell Renal Cell Carcinoma

Interventions: Drug: Everolimus
Drug: Sunitinib

First Posted Date: 2010-04-22

Last Posted Date: 2018-01-16

Lead Sponsor: Duke University

Target Recruit Count: 131

Registration Number: NCT01108445

Locations: 🇬🇧
The Royal Marsden NHS, London, England, United Kingdom
🇬🇧
Weston Park Hospital, Sheffield, England, United Kingdom
🇺🇸
Duke Univeristy Medical Center, Durham, North Carolina, United States

and more 15 locations

Pilot Study of Neo-Adjuvant Everolimus to Treat Advanced Renal Cell Carcinoma - Analysis of Biomarkers

Not Applicable

Completed

Conditions: Carcinoma, Renal Cell

Interventions: Drug: everolimus

First Posted Date: 2010-04-21

Last Posted Date: 2018-04-04

Lead Sponsor: St. Joseph's Healthcare Hamilton

Target Recruit Count: 20

Registration Number: NCT01107509

Locations: 🇨🇦
St. Joseph's Healthcare, Hamilton, Ontario, Canada

Everolimus in Breast Cancer Patients After Pre-operative Chemotherapy

Phase 2

Conditions: Breast Neoplasms

Interventions: Drug: Everolimus

First Posted Date: 2010-03-17

Last Posted Date: 2012-05-24

Lead Sponsor: Organisation for Oncology and Translational Research

Target Recruit Count: 50

Registration Number: NCT01088893

Locations: 🇨🇳
Unimed Medical Institute, Hong Kong, China

Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

Phase 1

Completed

Conditions: Chronic Lymphocytic Leukemia
Indolent Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: Idelalisib
Drug: Bortezomib
Drug: Rituximab
Drug: Ofatumumab
Drug: Fludarabine
Drug: Everolimus
Drug: Chlorambucil
Drug: Bendamustine
Drug: Lenalidomide

First Posted Date: 2010-03-17

Last Posted Date: 2021-03-18

Lead Sponsor: Gilead Sciences

Target Recruit Count: 241

Registration Number: NCT01088048

Locations: 🇺🇸
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
🇺🇸
Willamette Valley Cancer Institute and Research Center, Springfield, Oregon, United States
🇺🇸
Clearview Cancer Institute, Huntsville, Alabama, United States

and more 8 locations