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

Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC)

Phase 2

Completed

Conditions: Fibrolamellar Carcinoma
Fibrolamellar Liver Cancer

Interventions: Drug: letrozole plus leuprolide
Drug: combination of everolimus, letrozole and leuprolide
Drug: everolimus

First Posted Date: 2012-07-17

Last Posted Date: 2022-12-29

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 28

Registration Number: NCT01642186

Locations: 🇺🇸
University of California San Francisco, San Francisco, California, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
John Hopkins Medical Center, Baltimore, Maryland, United States

and more 3 locations

Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer

Phase 1

Completed

Conditions: Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Basal Cell Carcinoma of the Lip
Recurrent Colon Cancer
Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
Recurrent Lymphoepithelioma of the Nasopharynx
Recurrent Lymphoepithelioma of the Oropharynx
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
Recurrent Mucoepidermoid Carcinoma of the Oral Cavity

Interventions: Drug: everolimus
Biological: cetuximab
Other: pharmacological study
Other: laboratory biomarker analysis

First Posted Date: 2012-07-11

Last Posted Date: 2012-07-11

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 12

Registration Number: NCT01637194

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Everolimus in Treating Cutaneous T-cell Lymphoma

Phase 2

Terminated

Conditions: Cutaneous T-Cell Lymphoma

Interventions: Drug: Everolimus

First Posted Date: 2012-07-10

Last Posted Date: 2017-01-12

Lead Sponsor: Adam Lerner

Target Recruit Count: 3

Registration Number: NCT01637090

Locations: 🇺🇸
Boston Medical Center, Boston, Massachusetts, United States

Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.

Not Applicable

Completed

Conditions: Advanced Solid Tumors
Cancer

Interventions: Drug: Sunitinib
Drug: Sorafenib
Drug: Erlotinib
Drug: Everolimus
Drug: Lapatinib
Drug: Dasatinib
Drug: Pazopanib
Drug: Vemurafenib
Procedure: tumor biopsy
Procedure: skin biopsy (optional)

First Posted Date: 2012-07-10

Last Posted Date: 2021-04-15

Lead Sponsor: Amsterdam UMC, location VUmc

Target Recruit Count: 43

Registration Number: NCT01636908

Locations: 🇳🇱
VUMedical Center, Amsterdam, Netherlands

The Everolimus-Transplant Exit Strategy Trial (E-TEST)

Phase 3

Terminated

Conditions: Kidney Failure, Chronic

Interventions: Drug: Everolimus

First Posted Date: 2012-07-10

Last Posted Date: 2018-02-05

Lead Sponsor: Ashtar Chami

Target Recruit Count: 1

Registration Number: NCT01636466

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States

Renal Transplantation in the Elderly - nEverOld Study

Phase 4

Conditions: Chronic Renal Failure (CRF)
Graft Failure
Transplant; Failure, Kidney
Renal Transplant Rejection

Interventions: Drug: Everolimus

First Posted Date: 2012-06-28

Last Posted Date: 2015-12-04

Lead Sponsor: University of Sao Paulo General Hospital

Target Recruit Count: 90

Registration Number: NCT01631058

Locations: 🇧🇷
Clinical Hospital of the School of Medicine, University of Sao Paulo, Sao Paulo, SP, Brazil

Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors

Phase 2

Terminated

Conditions: Pancreatic Neuroendocrine Tumors (pNET)

Interventions: Drug: BEZ235
Drug: Everolimus

First Posted Date: 2012-06-27

Last Posted Date: 2016-04-07

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 62

Registration Number: NCT01628913

Locations: 🇺🇸
Cedars Sinai Medical Center SC-3, Los Angeles, California, United States
🇺🇸
Montefiore Medical Center SC, Bronx, New York, United States
🇺🇸
University of Colorado Univ Colorado, Aurora, Colorado, United States

and more 2 locations