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

Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET

Phase 2

Terminated

Conditions: Islet Cell Tumor

Interventions: Drug: Everolimus
Drug: Pasireotide LAR

First Posted Date: 2011-06-16

Last Posted Date: 2016-12-20

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 160

Registration Number: NCT01374451

Locations: 🇺🇸
Dana Farber Cancer Institute SC-2, Boston, Massachusetts, United States
🇺🇸
Montefiore Medical Center MMC, Bronx, New York, United States
🇺🇸
Oregon Health & Science University Knight Cancer Institute, Portland, Oregon, United States

and more 2 locations

Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate

Phase 4

Completed

Conditions: Renal Transplant Failure
Transplant; Complication, Rejection
Cytomegalovirus Infection

Interventions: Drug: Basiliximabe
Drug: Thymoglobulin
Drug: mycophenolate sodium
Drug: Everolimus
Drug: Tacrolimus

First Posted Date: 2011-05-16

Last Posted Date: 2015-03-23

Lead Sponsor: Hospital do Rim e Hipertensão

Target Recruit Count: 300

Registration Number: NCT01354301

Locations: 🇧🇷
Hospital do rim e Hipertensao, Sao Paulo, Brazil

89Zr-bevacizumab PET Imaging in Patients With Neuroendocrine Tumors

Completed

Conditions: Neuroendocrine Tumors

Interventions: Drug: 89Zr-bevacizumab
Drug: Everolimus

First Posted Date: 2011-04-19

Last Posted Date: 2012-04-03

Lead Sponsor: University Medical Center Groningen

Target Recruit Count: 14

Registration Number: NCT01338090

Locations: 🇳🇱
University Medical Center Groningen, Groningen, Netherlands

Everolimus, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Untreated Diffuse Large B-Cell Lymphoma

Phase 1

Completed

Conditions: Lymphoma

Interventions: Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: everolimus
Drug: prednisone
Drug: vincristine sulfate

First Posted Date: 2011-04-13

Last Posted Date: 2017-08-10

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 26

Registration Number: NCT01334502

Locations: 🇺🇸
Mayo Clinic Cancer Center, Rochester, Minnesota, United States

Everolimus, Erlotinib Hydrochloride, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer Previously Treated With Radiation Therapy

Phase 1

Withdrawn

Conditions: Recurrent Salivary Gland Cancer
Recurrent Verrucous Carcinoma of the Oral Cavity
Salivary Gland Squamous Cell Carcinoma
Tongue Cancer
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity

Interventions: Drug: everolimus
Drug: erlotinib hydrochloride
Procedure: biopsy
Other: laboratory biomarker analysis
Other: immunohistochemistry staining method
Genetic: polyacrylamide gel electrophoresis
Other: pharmacological study
Radiation: external beam radiation therapy
Genetic: microarray analysis

First Posted Date: 2011-04-11

Last Posted Date: 2023-04-04

Lead Sponsor: Fox Chase Cancer Center

Registration Number: NCT01332279

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

Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer

Phase 2

Terminated

Conditions: Castrate Resistant Prostate Cancer
Prostate Cancer
Chemotherapy Naive Prostate Cancer

Interventions: Drug: Pasireotide
Drug: Everolimus
Other: Laboratory biomarker analysis

First Posted Date: 2011-03-11

Last Posted Date: 2018-04-25

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 6

Registration Number: NCT01313559

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States

Everolimus and Docetaxel in Treating Patients With Recurrent, Locally Advanced, or Metastatic Head and Neck Cancer

Phase 1

Terminated

Conditions: Head and Neck Cancer

First Posted Date: 2011-03-11

Last Posted Date: 2011-12-12

Lead Sponsor: University College, London

Target Recruit Count: 4

Registration Number: NCT01313390

Locations: 🇬🇧
UCL Cancer Institute, London, England, United Kingdom

A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases

Phase 2

Completed

Conditions: HER-2 Positive Breast Cancer

Interventions: Drug: Everolimus
Drug: Vinorelbine
Drug: Trastuzumab

First Posted Date: 2011-03-01

Last Posted Date: 2018-12-17

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 32

Registration Number: NCT01305941

Locations: 🇺🇸
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸
Carolinas Healthcare System, Charlotte, North Carolina, United States
🇺🇸
University Of Alabama at Birmingham, Birmingham, Alabama, United States

and more 1 locations