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 Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Placebo
Drug: Everolimus
Drug: Trastuzumab
Drug: Paclitaxel

First Posted Date: 2009-04-06

Last Posted Date: 2018-12-19

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 719

Registration Number: NCT00876395

Locations: 🇺🇸
Comprehensive Blood and Cancer Center Dept. of CBCC (2), Bakersfield, California, United States
🇺🇸
New York Oncology Hematology NYOH Amsterdam, Albany, New York, United States
🇺🇸
Texas Oncology Charles A. Sammons Cancer Ctr, Dallas, Texas, United States

and more 24 locations

Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

Phase 2

Completed

Conditions: Endometrial Cancer

Interventions: Drug: everolimus

First Posted Date: 2009-03-27

Last Posted Date: 2014-10-29

Lead Sponsor: ARCAGY/ GINECO GROUP

Target Recruit Count: 44

Registration Number: NCT00870337

Locations: 🇫🇷
Hotel Dieu de Paris, Paris, France

Everolimus Plus Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Phase 2

Completed

Conditions: Diffuse Large B-cell Lymphoma

First Posted Date: 2009-03-26

Last Posted Date: 2014-10-27

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 26

Registration Number: NCT00869999

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconsess Medical Center, Boston, Massachusetts, United States

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Everolimus
Drug: Everolimus Placebo
Drug: Exemestane

First Posted Date: 2009-03-18

Last Posted Date: 2017-05-02

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 724

Registration Number: NCT00863655

Locations: 🇺🇸
University of Texas Southwestern Medical Center SimmonsComprehensiveCancerCtr., Dallas, Texas, United States
🇺🇸
Mercy Medical Center Medical Oncology & Hematology, Baltimore, Maryland, United States
🇺🇸
Crescent City Research Consortium, LLC Dept of Hem&Onc Specialist - 2, Metairie, Louisiana, United States

and more 61 locations

The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration

Phase 2

Terminated

Conditions: Choroidal Neo-Vascular Age-onset Macular Degeneration
Age-related Macular Degeneration

Interventions: Drug: Everolimus
Drug: Ranibizumab

First Posted Date: 2009-03-06

Last Posted Date: 2011-08-19

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 16

Registration Number: NCT00857259

Locations: 🇬🇧
Novartis Investigative Site, Southampton, United Kingdom
🇺🇸
Retina-Vitreous Associates Medical Group, Beverley Hills, California, United States
🇺🇸
Discover Vision Center, Independence, Missouri, United States

and more 4 locations

Everolimus in Treating Women With Breast Cancer That Can Be Removed by Surgery

Phase 2

Withdrawn

Conditions: Breast Cancer

Interventions: Drug: everolimus
Procedure: therapeutic conventional surgery

First Posted Date: 2009-03-04

Last Posted Date: 2017-12-02

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Registration Number: NCT00855114

Locations: 🇺🇸
University of Minnesota Children's Hospital - Fairview, Minneapolis, Minnesota, United States

Everolimus (RAD001) For Advanced Renal Cell Carcinoma (RCC) Before Kidney Removal

Phase 2

Terminated

Conditions: Kidney Cancer

Interventions: Drug: everolimus

First Posted Date: 2009-01-29

Last Posted Date: 2016-03-21

Lead Sponsor: Linda C. Higgins

Target Recruit Count: 15

Registration Number: NCT00831480

Locations: 🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
Baylor College of Medicine, Houston, Texas, United States

Biomarker Trial of Everolimus in Patients With Advanced Renal Cell Carcinoma

Phase 2

Completed

Conditions: Renal Cancer
Renal Cell Carcinoma

Interventions: Drug: Everolimus

First Posted Date: 2009-01-22

Last Posted Date: 2021-02-24

Lead Sponsor: Beth Israel Deaconess Medical Center

Target Recruit Count: 25

Registration Number: NCT00827359

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States