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
-

ARN 509 Plus Everolimus in Men With Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment With Abiraterone Acetate

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-04-08
Last Posted Date
2023-05-26
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
9
Registration Number
NCT02106507
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Novartis Everolimus Transition

First Posted Date
2014-03-26
Last Posted Date
2018-08-08
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
60
Registration Number
NCT02096107
Locations
🇺🇸

Medical University of South Carolina, Charleston, South Carolina, United States

MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Regimens in Kidney Transplantation

Not Applicable
Conditions
Interventions
First Posted Date
2014-03-19
Last Posted Date
2014-03-19
Lead Sponsor
Chulalongkorn University
Target Recruit Count
50
Registration Number
NCT02091973
Locations
🇹🇭

Chulalongkorn University, Bangkok, Thailand

Everolimus + Very Low Tacrolimus vs Enteric-coated Mycophenolate Sodium + Low Tacrolimus in de Novo Renal Transplant

First Posted Date
2014-03-12
Last Posted Date
2019-02-22
Lead Sponsor
Ronaldo de Matos Esmeraldo, MD
Target Recruit Count
120
Registration Number
NCT02084446
Locations
🇧🇷

Hospital Geral de Fortaleza, Fortaleza, Ceará, Brazil

Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer

First Posted Date
2014-03-07
Last Posted Date
2024-01-30
Lead Sponsor
Baylor Research Institute
Target Recruit Count
336
Registration Number
NCT02081755
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

Northwestern University School of Medicine, Chicago, Illinois, United States

and more 6 locations

Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors

First Posted Date
2014-03-04
Last Posted Date
2020-12-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
79
Registration Number
NCT02077933
Locations
🇬🇧

Novartis Investigative Site, Manchester, United Kingdom

🇺🇸

Memorial Sloan Kettering Cancer Center SC - BYL719Z2102, New York, New York, United States

🇺🇸

Highlands Oncology Group, Fayetteville, Arkansas, United States

Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients

First Posted Date
2014-03-04
Last Posted Date
2019-07-24
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
14
Registration Number
NCT02077556
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer

First Posted Date
2014-02-21
Last Posted Date
2017-02-13
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
92
Registration Number
NCT02069093
Locations
🇺🇸

Regional Cancer Care Associates Cancer and Hematologic Disease, Cherry Hill, New Jersey, United States

🇺🇸

Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2), Morristown, New Jersey, United States

🇺🇸

Highlands Oncology Group Highlands Oncology Group (22), Fayetteville, Arkansas, United States

and more 20 locations

Differentiating Everolimus Versus Sirolimus in Combination With Calcineurin Inhibitors in Kidney Transplant Patients

Phase 4
Withdrawn
Conditions
Interventions
First Posted Date
2014-02-14
Last Posted Date
2014-12-02
Lead Sponsor
University of Colorado, Denver
Registration Number
NCT02062892

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

First Posted Date
2014-02-06
Last Posted Date
2024-08-28
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
198
Registration Number
NCT02057133
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

Highlands Oncology Group - Duplicate 2, Rogers, Arkansas, United States

🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

and more 10 locations
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