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

Everolimus in Patients With Metastatic Renal Cell Carcinoma Following Progression on Prior Bevacizumab Treatment

Phase 4

Completed

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Everolimus

First Posted Date: 2014-02-06

Last Posted Date: 2014-02-06

Lead Sponsor: Kidney Cancer Research Bureau

Target Recruit Count: 37

Registration Number: NCT02056587

Locations: 🇷🇺
Tatarstan Regional Cancer Center, Kazan, Tatarstan, Russian Federation
🇷🇺
Altai Regional Cancer Center, Barnaul, Russian Federation
🇷🇺
N.N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation

Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy

Phase 2

Completed

Conditions: Thymoma and Thymic Carcinoma

Interventions: Drug: Everolimus

First Posted Date: 2014-01-29

Last Posted Date: 2022-09-10

Lead Sponsor: Armando Santoro, MD

Target Recruit Count: 41

Registration Number: NCT02049047

Locations: 🇮🇹
Istituto Clinico Humanitas, Rozzano, MI, Italy

Evaluate Efficacy Study of Combination Therapy of Everolimus and Low Dose Tacrolimus in Renal Allograft Recipients

Phase 4

Conditions: Kidney; Complications, Allograft

Interventions: Drug: Everolimus
Drug: Tacrolimus
Drug: Mycophenolic acid

First Posted Date: 2014-01-15

Last Posted Date: 2014-09-25

Lead Sponsor: Seoul St. Mary's Hospital

Target Recruit Count: 234

Registration Number: NCT02036554

Locations: 🇰🇷
division of nephrology;Seoul St Mary's Hospital, Seoul, Korea, Republic of

Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously Treated With Surgery

Phase 2

Terminated

Conditions: Pancreatic Polypeptide Tumor
Gastrinoma
Glucagonoma
Insulinoma
Liver Metastases
Recurrent Islet Cell Carcinoma
Somatostatinoma

Interventions: Other: placebo
Drug: everolimus

First Posted Date: 2014-01-09

Last Posted Date: 2023-06-29

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 2

Registration Number: NCT02031536

Locations: 🇺🇸
Ecog-Acrin, Boston, Massachusetts, United States

Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Everolimus
Drug: Exemestane

First Posted Date: 2014-01-07

Last Posted Date: 2023-08-24

Lead Sponsor: Jules Bordet Institute

Target Recruit Count: 55

Registration Number: NCT02028364

Locations: 🇧🇪
CHU Ambroise Paré, Mons, Belgium
🇧🇪
Cliniques Universtaires Saint-Luc, Bruxelles, Belgium
🇧🇪
institut Jules Bordet, Bruxelles, Belgium

and more 2 locations