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.
...

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

Pilot Study of mTOR Inhibitor Therapy in Peutz-Jeghers Syndrome

Phase 2

Terminated

Conditions: Peutz-Jeghers Syndrome

Interventions: Drug: Everolimus

First Posted Date: 2008-12-19

Last Posted Date: 2013-07-26

Lead Sponsor: University of Utah

Target Recruit Count: 3

Registration Number: NCT00811590

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

RAD001(Everolimus) in Treating Patients With Myelodysplastic Syndromes

Phase 2

Terminated

Conditions: Myelodysplastic Syndromes

Interventions: Drug: everolimus
Other: laboratory biomarker analysis
Procedure: Bone marrow aspirate/biopsy

First Posted Date: 2008-12-17

Last Posted Date: 2019-03-07

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 7

Registration Number: NCT00809185

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

RT, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in First-line Treatment of GBM

Phase 2

Completed

Conditions: Glioblastoma Multiforme

Interventions: Radiation: Radiation therapy
Drug: Temozolomide
Drug: Bevacizumab
Drug: Everolimus

First Posted Date: 2008-12-10

Last Posted Date: 2021-12-08

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 68

Registration Number: NCT00805961

Locations: 🇺🇸
Peninsula Cancer Institute, Newport News, Virginia, United States
🇺🇸
Clearview Cancer Institute, Huntsville, Alabama, United States
🇺🇸
Northeast Georgia Medical Center, Gainesville, Georgia, United States

and more 10 locations

Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium

Phase 2

Completed

Conditions: Bladder Cancer
Metastatic Transitional Cell Carcinoma

Interventions: Drug: Everolimus

First Posted Date: 2008-12-09

Last Posted Date: 2022-11-25

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 46

Registration Number: NCT00805129

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

Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

Phase 2

Completed

Conditions: Uveitis

Interventions: Drug: everolimus

First Posted Date: 2008-12-08

Last Posted Date: 2015-05-27

Lead Sponsor: Carsten Heinz

Target Recruit Count: 12

Registration Number: NCT00803816

Locations: 🇩🇪
Department of Ophthalmology at St. Franziskus Hospital, Muenster, Germany

CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial

Phase 3

Conditions: Skin Cancer
Cardiac Transplantation

Interventions: Drug: Everolimus

First Posted Date: 2008-11-27

Last Posted Date: 2013-12-12

Lead Sponsor: Hospices Civils de Lyon

Target Recruit Count: 175

Registration Number: NCT00799188

Locations: 🇫🇷
HOSPICES CIVILS de LYON, Lyon, France

Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)

Phase 3

Completed

Conditions: Tuberous Sclerosis
Subependymal Giant Cell Astrocytoma

Interventions: Drug: Placebo
Drug: Everolimus

First Posted Date: 2008-11-13

Last Posted Date: 2016-02-03

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 117

Registration Number: NCT00789828

Locations: 🇬🇧
Novartis Investigative Site, Bristol, United Kingdom
🇺🇸
Minnesota Epilepsy Group - PA, St. Paul, Minnesota, United States
🇺🇸
Children's Hospital Oakland Hematology/Oncology Dept, Oakland, California, United States

and more 10 locations

Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

Phase 3

Completed

Conditions: Diffuse Large B-cell Lymphoma

Interventions: Drug: Everolimus
Drug: Everolimus Placebo

First Posted Date: 2008-11-13

Last Posted Date: 2017-07-12

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 742

Registration Number: NCT00790036

Locations: 🇺🇸
Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2), Charleston, South Carolina, United States
🇺🇸
Ironwood Cancer and Research Centers SC, Chandler, Arizona, United States
🇺🇸
Levine Cancer Institute Oncology, Charlotte, North Carolina, United States

and more 32 locations

Everolimus (RAD001) for Children With Chemotherapy-Refractory Progressive or Recurrent Low-Grade Gliomas

Phase 2

Completed

Conditions: Glioma
Low-grade Glioma
Astrocytoma

Interventions: Drug: everolimus

First Posted Date: 2008-10-31

Last Posted Date: 2018-08-15

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 23

Registration Number: NCT00782626

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Florida College of Medicine, Gainesville, Florida, United States
🇺🇸
Memorial Sloan-Kettering Cancer Institute, New York, New York, United States

and more 7 locations

S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery

Phase 2

Completed

Conditions: Malignant Mesothelioma

Interventions: Drug: everolimus

First Posted Date: 2008-10-09

Last Posted Date: 2020-03-06

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 61

Registration Number: NCT00770120

Locations: 🇺🇸
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport, Tennessee, United States
🇺🇸
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
🇺🇸
Doctors Hospital at Ohio Health, Columbus, Ohio, United States

and more 126 locations

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