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

Ceritinib and Everolimus in Treating Patients with Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer

Phase 1

Active, not recruiting

Conditions: ALK Positive
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
ROS1 Gene Rearrangement
Stage IIIB Lung Non-Small Cell Cancer AJCC V7
Stage IV Lung Non-Small Cell Cancer AJCC V7

Interventions: Drug: Ceritinib
Drug: Everolimus
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

First Posted Date: 2014-12-22

Last Posted Date: 2024-12-20

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 37

Registration Number: NCT02321501

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery

Phase 2

Terminated

Conditions: Neuroendocrine Tumors
Neuroendocrine Neoplasms
Carcinoma, Neuroendocrine
Neuroendocrine Carcinoma
Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas

Interventions: Drug: Sunitinib
Drug: Everolimus

First Posted Date: 2014-12-12

Last Posted Date: 2020-09-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 16

Registration Number: NCT02315625

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

Everolimus trIal for Advanced prememopausaL Breast Cancer Patients

Phase 2

Conditions: Metastatic Breast Cancer

Interventions: Drug: Everolimus
Drug: Goserelin
Drug: Letrozole

First Posted Date: 2014-12-09

Last Posted Date: 2014-12-09

Lead Sponsor: Chinese Academy of Medical Sciences

Target Recruit Count: 200

Registration Number: NCT02313051

Locations: 🇨🇳
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China

Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Everolimus
Drug: Exemestane
Drug: Tamoxifen
Drug: Fulvestrant
Drug: Anastrozole
Drug: Letrozole
Drug: Toremifine

First Posted Date: 2014-11-17

Last Posted Date: 2020-02-17

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 48

Registration Number: NCT02291913

Locations: 🇺🇸
Woodlands Medical Specialists, Pensacola, Florida, United States
🇺🇸
Hope Cancer Center, Terre Haute, Indiana, United States
🇺🇸
Center for Cancer and Blood Disorders, Fort Worth, Texas, United States

and more 5 locations

Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Phase 2

Completed

Conditions: Recurrent Primary Peritoneal Carcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Seromucinous Carcinoma
Ovarian Serous Cystadenocarcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Germ Cell Tumor
Recurrent Ovarian Carcinoma
Ovarian Serous Surface Papillary Adenocarcinoma
Undifferentiated Ovarian Carcinoma

Interventions: Drug: Everolimus
Other: Laboratory Biomarker Analysis
Drug: Letrozole

First Posted Date: 2014-11-05

Last Posted Date: 2020-10-23

Lead Sponsor: Mayo Clinic

Target Recruit Count: 20

Registration Number: NCT02283658

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer

Phase 2

Terminated

Conditions: Estrogen Receptor-positive Breast Cancer
Gastrinoma
Glucagonoma
HER2-negative Breast Cancer
Insulinoma
Mucositis
Oral Complications
Pancreatic Polypeptide Tumor
Progesterone Receptor-positive Breast Cancer
Recurrent Breast Cancer

Interventions: Drug: Everolimus

First Posted Date: 2014-10-24

Last Posted Date: 2017-02-03

Lead Sponsor: Emory University

Target Recruit Count: 2

Registration Number: NCT02273752

Locations: 🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States

Phase II Study of Everolimus Beyond Progression

Phase 2

Terminated

Conditions: Estrogen Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Progesterone Receptor-positive Breast Cancer
Stage IIIA Breast Cancer
Stage IV Breast Cancer
Recurrent Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer

Interventions: Drug: everolimus
Drug: anastrozole
Drug: letrozole
Drug: tamoxifen citrate
Drug: fulvestrant
Drug: megestrol acetate

First Posted Date: 2014-10-21

Last Posted Date: 2022-04-05

Lead Sponsor: Emory University

Target Recruit Count: 3

Registration Number: NCT02269670

Locations: 🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

OPALINE : A Study Of Morbidity And Mortality At 2 Years

Completed

Conditions: Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive

Interventions: Drug: chemotherapies recommended in france
Drug: sunitinib
Drug: everolimus

First Posted Date: 2014-10-15

Last Posted Date: 2023-11-13

Lead Sponsor: Pfizer

Target Recruit Count: 144

Registration Number: NCT02264665

Locations: 🇫🇷
Groupe Hospitalier Cochin, Paris Cedex, France
🇫🇷
CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition, Strasbourg Cedex, France
🇫🇷
Hopital Foch, Onco Hermatologie, Suresnes cedex, France

and more 31 locations