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

Phase I-II Everolimus and Sorafenib in Recurrent High-Grade Gliomas

Phase 1

Completed

Conditions: Brain Tumor
Glioblastoma
Anaplastic Glioma

Interventions: Drug: everolimus
Drug: sorafenib

First Posted Date: 2011-09-15

Last Posted Date: 2022-06-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 86

Registration Number: NCT01434602

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients

Phase 1

Completed

Conditions: Solid Tumors
Advanced Cancers

Interventions: Drug: Pazopanib
Drug: Everolimus

First Posted Date: 2011-09-08

Last Posted Date: 2023-06-06

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 62

Registration Number: NCT01430572

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer

Phase 1

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: IPI-504
Drug: Everolimus

First Posted Date: 2011-09-02

Last Posted Date: 2014-11-13

Lead Sponsor: Infinity Pharmaceuticals, Inc.

Target Recruit Count: 47

Registration Number: NCT01427946

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
University of Colorado Denver, Aurora, Colorado, United States

and more 2 locations

Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study

Phase 2

Conditions: Liver Failure
Liver Diseases
Liver Cirrhosis
Liver Neoplasms

Interventions: Drug: Everolimus

First Posted Date: 2011-08-26

Last Posted Date: 2012-07-18

Lead Sponsor: Azienda Ospedaliera di Padova

Target Recruit Count: 117

Registration Number: NCT01423708

Locations: 🇮🇹
Ospedali Riuniti - Bergamo, Bergamo, BG, Italy
🇮🇹
Irccs Ospedale Maggiore Policlinico Di Milano, Milano, MI, Italy
🇮🇹
Azienda Ospedaliera di Padova, Padua, PD, Italy

and more 4 locations

A Phase II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation of Oral mTOR-inhibitor Everolimus (RAD001) 10 mg Daily in Patients Suffering From Classic or Endemic Kaposi's Sarcoma

Phase 2

Terminated

Conditions: Kaposi Sarcoma

Interventions: Drug: everolimus

First Posted Date: 2011-08-09

Last Posted Date: 2012-01-02

Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Target Recruit Count: 11

Registration Number: NCT01412515

Locations: 🇫🇷
Hospital Saint Louis, Paris, France

Everolimus in de Novo Kidney Transplant Recipients

Phase 3

Completed

Conditions: Kidney Transplantation

Interventions: Drug: Everolimus
Drug: Cyclosporine
Drug: Mycophenolate sodium
Drug: Steroids

First Posted Date: 2011-08-05

Last Posted Date: 2017-06-16

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 383

Registration Number: NCT01410448

Locations: 🇮🇹
Novartis Investigative Site, Novara, Italy

Rotating Pazopanib and Everolimus to Avoid Resistance

Phase 2

Completed

Conditions: Clear Cell Renal Carcinoma

Interventions: Drug: Pazopanib
Drug: Everolimus

First Posted Date: 2011-08-02

Last Posted Date: 2014-07-16

Lead Sponsor: Netherlands Working Group on Immunotherapy of Oncology

Target Recruit Count: 101

Registration Number: NCT01408004

Locations: 🇳🇱
St. Franciscus Gasthuis, Rotterdam, Zuid-Holland, Netherlands
🇳🇱
Medisch Centrum Alkmaar, Alkmaar, Netherlands
🇳🇱
Haga Ziekenhuis, Den Haag, Netherlands

and more 14 locations