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
-

Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients

First Posted Date
2012-06-21
Last Posted Date
2016-08-15
Lead Sponsor
University of California, San Francisco
Target Recruit Count
40
Registration Number
NCT01624948
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

Study of Everolimus in de Novo Renal Transplant Recipients

Not Applicable
Terminated
Conditions
Interventions
First Posted Date
2012-06-01
Last Posted Date
2013-06-12
Lead Sponsor
Helady Pinheiro, MD, PhD
Target Recruit Count
1
Registration Number
NCT01609673
Locations
🇧🇷

Fundação IMEPEN, Juiz de Fora, MG, Brazil

🇧🇷

Hospital São João de Deus/Fundação Geraldo Corrêa, Divinópolis, MG, Brazil

🇧🇷

Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês, Montes Claros, MG, Brazil

and more 1 locations

A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

First Posted Date
2012-05-31
Last Posted Date
2012-05-31
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Target Recruit Count
120
Registration Number
NCT01608412
Locations
🇧🇷

Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil

Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer

First Posted Date
2012-05-10
Last Posted Date
2020-06-04
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
27
Registration Number
NCT01596140
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

A Prospective, Open Label Study of CERtican in KIdney Transplantation

Phase 4
Completed
Conditions
Interventions
First Posted Date
2012-05-09
Last Posted Date
2017-03-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
54
Registration Number
NCT01594268
Locations
🇰🇷

Novartis Investigative Site, Suwon, Korea, Republic of

Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer

First Posted Date
2012-04-20
Last Posted Date
2024-06-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
153
Registration Number
NCT01582191
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Phase II Study of Everolimus Combined With Octreotide LAR to Treat Advanced GI NET

First Posted Date
2012-03-30
Last Posted Date
2018-01-03
Lead Sponsor
Grupo Espanol de Tumores Neuroendocrinos
Target Recruit Count
43
Registration Number
NCT01567488
Locations
🇪🇸

Instituto Catalán de Oncologia, Hospitalet de Llobregat, Barcelona, Spain

A Study to Identify a Biomarker Predictive for Response on Everolimus in Solid Tumors (CPCT-03)

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2012-03-29
Last Posted Date
2018-03-09
Lead Sponsor
UMC Utrecht
Target Recruit Count
73
Registration Number
NCT01566279
Locations
🇳🇱

NKI-AVL, Amsterdam, Noord Holland, Netherlands

🇳🇱

Erasmus Medical Center, Rotterdam, Zuid Holland, Netherlands

🇳🇱

University Medical Center Utrecht, Utrecht, Netherlands

3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial

First Posted Date
2012-03-27
Last Posted Date
2021-04-02
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
124
Registration Number
NCT01563354
Locations
🇬🇧

Novartis Investigative Site, London, United Kingdom

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