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 Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma

Phase 1

Completed

Conditions: Recurrent Adult Soft Tissue Sarcoma
Adult Synovial Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma

Interventions: Other: diagnostic laboratory biomarker analysis
Drug: everolimus
Drug: imatinib mesylate

First Posted Date: 2011-01-24

Last Posted Date: 2014-10-08

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 14

Registration Number: NCT01281865

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation

Phase 4

Terminated

Conditions: Renal Transplantation

Interventions: Drug: everolimus

First Posted Date: 2011-01-13

Last Posted Date: 2017-08-07

Lead Sponsor: Dianet Dialysis Centers

Target Recruit Count: 13

Registration Number: NCT01276834

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

Pasireotide & Everolimus in Adult Patients With Radioiodine-Refractory Differentiated & Medullary Thyroid Cancer

Phase 2

Completed

Conditions: Thyroid Cancer

Interventions: Drug: Pasireotide
Drug: Everolimus and Pasireotide
Drug: Everolimus

First Posted Date: 2011-01-05

Last Posted Date: 2021-02-17

Lead Sponsor: Emory University

Target Recruit Count: 42

Registration Number: NCT01270321

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

Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

Phase 4

Withdrawn

Conditions: Kidney Transplantation

Interventions: Drug: Everolimus

First Posted Date: 2011-01-04

Last Posted Date: 2017-02-24

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT01269684

Locations: 🇨🇭
Novartis Investigative Site, Zurich, Switzerland

SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance

Phase 4

Completed

Conditions: Renal Function and Chronic Allograft Vasculopathy

Interventions: Drug: Cyclosporine
Drug: Mycophenolate mofetil
Drug: Corticosteroids
Drug: Everolimus
Drug: Anti Thymocyte Globulin

First Posted Date: 2010-12-24

Last Posted Date: 2015-06-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 115

Registration Number: NCT01266148

Locations: 🇸🇪
Novartis Investigative Site, Lund, Sweden

Open Label, Single Arm Trial to Characterize Patients With Metastatic RCC Treated With Everolimus After Failure of the First VEGF-targeted Therapy (MARC-2)

Phase 4

Completed

Conditions: Metastatic Renal Cell Carcinoma
Failure of Exactly One Prior VEGF-targeted Therapy

Interventions: Drug: Everolimus

First Posted Date: 2010-12-24

Last Posted Date: 2017-11-14

Lead Sponsor: iOMEDICO AG

Target Recruit Count: 64

Registration Number: NCT01266837

Locations: 🇩🇪
Klinik für Innere Medizin (Tumorforschung), Universitätsklinikum Essen, Essen, Germany
🇩🇪
Urologie - Waldkrankenhaus St. Marien, Erlangen, Germany
🇩🇪
Klinik und Poliklinik für Urologie , Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, Dresden, Germany

and more 5 locations

Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone

Phase 2

Conditions: Differentiated Thyroid Cancer

Interventions: Drug: Everolimus
Drug: Sorafenib

First Posted Date: 2010-12-21

Last Posted Date: 2021-10-26

Lead Sponsor: Thomas Jefferson University

Target Recruit Count: 35

Registration Number: NCT01263951

Locations: 🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Everolimus for Patients With Relapsed/Refractory Germ Cell Cancer

Phase 2

Completed

Conditions: Testicular Cancer
Germ Cell Cancer

Interventions: Drug: Everolimus

First Posted Date: 2010-11-17

Last Posted Date: 2015-02-25

Lead Sponsor: Hannover Medical School

Target Recruit Count: 25

Registration Number: NCT01242631

Locations: 🇩🇪
Hannover Medical School, Hannover, Germany
🇩🇪
Universitatsklinikum Hamburg-Eppendorf, Hamburg, Germany
🇩🇪
Klinikum Harlaching München, München, Germany

and more 5 locations

Akt Inhibitor MK2206 or Everolimus in Treating Patients With Refractory Kidney Cancer

Phase 2

Terminated

Conditions: Metastatic Kidney Carcinoma
Recurrent Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v7
Stage III Renal Cell Cancer AJCC v7

Interventions: Drug: Akt Inhibitor MK2206
Drug: Everolimus
Other: Laboratory Biomarker Analysis

First Posted Date: 2010-11-11

Last Posted Date: 2019-10-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 43

Registration Number: NCT01239342

Locations: 🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Tower Cancer Research Foundation, Beverly Hills, California, United States
🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

and more 5 locations

Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant

Phase 4

Completed

Conditions: Renal Transplant Rejection
Immunosuppression

Interventions: Drug: Everolimus

First Posted Date: 2010-11-11

Last Posted Date: 2020-02-07

Lead Sponsor: Andre Barreto Pereira

Target Recruit Count: 30

Registration Number: NCT01239472

Locations: 🇧🇷
Santa Casa de Misericórdia de Belo Horizonte, Belo Horizonte, Minas Gerais, Brazil

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