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
-

Everolimus Post Orthotopic Liver Transplant

First Posted Date
2013-12-02
Last Posted Date
2017-08-10
Lead Sponsor
Tomoaki Kato
Target Recruit Count
50
Registration Number
NCT01998789
Locations
🇺🇸

Columbia University Medical Center-NYPH, New York, New York, United States

Adjunctive Everolimus (RAD 001) Therapy for Epilepsy in Children With Sturge-Weber Syndrome (SWS)

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2013-11-28
Last Posted Date
2016-05-05
Lead Sponsor
Baylor College of Medicine
Registration Number
NCT01997255
Locations
🇺🇸

Texas Children's Hospital, Houston, Texas, United States

Comparing Everolimus and Sirolimus in Renal Transplant Recipients

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2013-11-05
Last Posted Date
2022-10-21
Lead Sponsor
Ohio State University
Target Recruit Count
60
Registration Number
NCT01976390
Locations
🇺🇸

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States

Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study

First Posted Date
2013-10-11
Last Posted Date
2015-05-01
Lead Sponsor
Peking University Cancer Hospital & Institute
Target Recruit Count
60
Registration Number
NCT01960829
Locations
🇨🇳

LuSi, Beijing, Beijing, China

NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-08-29
Last Posted Date
2021-07-20
Lead Sponsor
Jenny C. Chang, MD
Target Recruit Count
24
Registration Number
NCT01931163
Locations
🇺🇸

Houston Methodist Hospital Willowbrook, Houston, Texas, United States

🇺🇸

The Methodist Hospital, Houston, Texas, United States

🇺🇸

Houston Methodist Hospital Sugar Land, Sugar Land, Texas, United States

Rapalogues for Autism Phenotype in TSC: A Feasibility Study

First Posted Date
2013-08-28
Last Posted Date
2021-03-29
Lead Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Target Recruit Count
3
Registration Number
NCT01929642
Locations
🇺🇸

Kennedy Krieger Institute, Baltimore, Maryland, United States

Assessing Everolimus in Fist Line Treatment on Patients With Metastatic Kidney Cancer

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2013-06-27
Last Posted Date
2016-02-10
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
61
Registration Number
NCT01888042
Locations
🇫🇷

Gustave Roussy, Villejuif, Val de Marne, France

A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys

First Posted Date
2013-06-17
Last Posted Date
2019-04-26
Lead Sponsor
Matthew Cooper
Target Recruit Count
25
Registration Number
NCT01878786
Locations
🇺🇸

Georgetown University Hospital, Washington, District of Columbia, United States

Phase 1 TheraSphere + Everolimus With Neuroendocrine Tumors (NETs) + Liver Only or Liver Dominant Disease

First Posted Date
2013-05-29
Last Posted Date
2014-07-22
Lead Sponsor
M.D. Anderson Cancer Center
Registration Number
NCT01864070

Safety and Efficacy of AEB071 and EVEROLIMUS in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma

First Posted Date
2013-05-15
Last Posted Date
2020-12-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
31
Registration Number
NCT01854606
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center Onc. Dept., New York, New York, United States

🇺🇸

Washington University School of Medicine Dept of Oncology., Saint Louis, Missouri, United States

🇺🇸

Sarah Cannon Research Institute Dept of Onc, Nashville, Tennessee, United States

and more 1 locations
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