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
-

Phase I/II Study of Weekly Abraxane and RAD001 in Women With Locally Adv. or Metastatic Breast Ca

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2009-07-08
Last Posted Date
2023-09-18
Lead Sponsor
Rutgers, The State University of New Jersey
Target Recruit Count
27
Registration Number
NCT00934895
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Rutgers Cancer Institute of New Jersey (Hamilton), Hamilton, New Jersey, United States

๐Ÿ‡บ๐Ÿ‡ธ

Cooper Hospital/University Medical Center, Camden, New Jersey, United States

๐Ÿ‡บ๐Ÿ‡ธ

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer

First Posted Date
2009-07-02
Last Posted Date
2015-05-07
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Target Recruit Count
145
Registration Number
NCT00930930
Locations
๐Ÿ‡บ๐Ÿ‡ธ

University of Alabama, Birmingham, Alabama, United States

๐Ÿ‡บ๐Ÿ‡ธ

Hershey Medical Center, Hershey, Pennsylvania, United States

๐Ÿ‡บ๐Ÿ‡ธ

The Methodist Hospital Research Institute, Houston, Texas, United States

and more 5 locations

Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma

First Posted Date
2009-06-11
Last Posted Date
2020-03-10
Lead Sponsor
Mayo Clinic
Target Recruit Count
124
Registration Number
NCT00918333
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

๐Ÿ‡บ๐Ÿ‡ธ

Mark O Hatfield-Warren Grant Magnuson Clinical Center, Bethesda, Maryland, United States

๐Ÿ‡บ๐Ÿ‡ธ

Mayo Clinic, Rochester, Minnesota, United States

Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer

First Posted Date
2009-06-08
Last Posted Date
2014-12-22
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
113
Registration Number
NCT00915603
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Wilshire Oncology Medical Group, LaVerne, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Mercy Hospital, Portland, Maine, United States

๐Ÿ‡บ๐Ÿ‡ธ

Aventura Medical Center, Aventura, Florida, United States

and more 12 locations

Phase II Trial of EVEROLIMUS ยฑ Trastuzumab in Hormone-Refractory Metastatic Breast Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-06-03
Last Posted Date
2018-12-05
Lead Sponsor
Emory University
Target Recruit Count
70
Registration Number
NCT00912340
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Emory University Hospital Midtown, Atlanta, Georgia, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

๐Ÿ‡บ๐Ÿ‡ธ

Emory University Winship Cancer Institute, Atlanta, Georgia, United States

and more 1 locations

Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

First Posted Date
2009-05-18
Last Posted Date
2009-05-18
Lead Sponsor
University Hospital, Antwerp
Target Recruit Count
152
Registration Number
NCT00903188
Locations
๐Ÿ‡ง๐Ÿ‡ช

Erasme University Hospital, Brussels, Belgium

๐Ÿ‡ง๐Ÿ‡ช

University Hospital, Ghent, Gent, Belgium

๐Ÿ‡ง๐Ÿ‡ช

University Hospital Brussels, Brussels, Belgium

and more 2 locations

Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-05-18
Last Posted Date
2016-11-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
471
Registration Number
NCT00903175
Locations
๐Ÿ‡บ๐Ÿ‡ธ

University of California at Los Angeles Dept. of UCLA (3), Los Angeles, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Loyola University Medical Center /Cardinal Bernardin Cancer Cardinal Bernardin Cancer (3), Maywood, Illinois, United States

๐Ÿ‡บ๐Ÿ‡ธ

Billings Clinic Dept of Billings Clinic(2), Billings, Montana, United States

and more 33 locations

Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation

First Posted Date
2009-04-29
Last Posted Date
2011-09-15
Lead Sponsor
Armin Goralczyk
Target Recruit Count
29
Registration Number
NCT00890253
Locations
๐Ÿ‡ฉ๐Ÿ‡ช

University Medical Center Goettingen, Goettingen, Germany

Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

First Posted Date
2009-04-23
Last Posted Date
2022-02-04
Lead Sponsor
GOG Foundation
Target Recruit Count
150
Registration Number
NCT00886691
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States

๐Ÿ‡บ๐Ÿ‡ธ

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States

๐Ÿ‡บ๐Ÿ‡ธ

Riverside Methodist Hospital, Columbus, Ohio, United States

and more 42 locations

Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)

First Posted Date
2009-04-10
Last Posted Date
2015-11-03
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
656
Registration Number
NCT00879333
Locations
๐Ÿ‡ฌ๐Ÿ‡ง

Novartis Investigative Site, Wolverhampton, United Kingdom

๐Ÿ‡บ๐Ÿ‡ธ

Henry Ford Hospital Dept. of Henry Ford Hospital, Detroit, Michigan, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Washington Cancer Care Seattle Cancer Alliance, Seattle, Washington, United States

and more 6 locations
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