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

Study of Everolimus (RAD001) in Patients With Recurrent Glioblastoma Multiforme (GBM)

Phase 2

Terminated

Conditions: Glioblastoma Multiforme

Interventions: Drug: Everolimus
Procedure: Surgery

First Posted Date: 2007-08-13

Last Posted Date: 2011-09-22

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 41

Registration Number: NCT00515086

Locations: 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States
🇺🇸
Duke University - Preston Robert Tisch Brain Tumor Center, Durham, North Carolina, United States
🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States

and more 5 locations

Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen

Phase 3

Completed

Conditions: Kidney Transplantation

Interventions: Drug: Everolimus
Drug: Myfortic
Drug: Sandimmun Optoral
Drug: Simulect®

First Posted Date: 2007-08-10

Last Posted Date: 2017-01-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 802

Registration Number: NCT00514514

Locations: 🇨🇭
Novartis Investigative Site, Bern, Switzerland

Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors

Phase 3

Completed

Conditions: Advanced Neuroendocrine Tumors of Pancreatic Origin

Interventions: Drug: Everolimus Placebo
Drug: Everolimus

First Posted Date: 2007-08-01

Last Posted Date: 2015-07-01

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 410

Registration Number: NCT00510068

Locations: 🇺🇸
University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2), Mobile, Alabama, United States
🇺🇸
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
🇺🇸
University of Texas/MD Anderson Cancer Center Dept of MD Anderson CancerCent, Houston, Texas, United States

and more 22 locations

Safe Renal Function In Long Term Heart Transplanted Patients

Phase 4

Conditions: Kidney Diseases
Heart Transplantation

Interventions: Drug: Everolimus

First Posted Date: 2007-07-20

Last Posted Date: 2008-02-13

Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

Target Recruit Count: 200

Registration Number: NCT00505102

Locations: 🇮🇹
Heart Transplantad Center OspedaliRiuniti Bergamo, Bergamo, Italy
🇮🇹
Heart Transplant Center Ospedali Riuniti, Bergamo, Italy

Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients

Phase 1

Completed

Conditions: Small-Cell Lung Cancer

Interventions: Drug: Everolimus

First Posted Date: 2007-04-27

Last Posted Date: 2020-12-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 20

Registration Number: NCT00466466

Locations: 🇫🇷
Novartis Investigative Site, Paris, France
🇺🇸
Dana Faber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Highlands Oncology Group, Fayetteville, Arkansas, United States

and more 3 locations

Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients

Phase 3

Completed

Conditions: De Novo Renal Transplantation

First Posted Date: 2007-04-23

Last Posted Date: 2016-11-16

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 20

Registration Number: NCT00464399

Locations: 🇳🇴
Novartis Investigative Site,, Oslo, Norway

Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Everolimus
Drug: Trastuzumab

First Posted Date: 2007-04-10

Last Posted Date: 2016-10-20

Lead Sponsor: Beth Israel Deaconess Medical Center

Target Recruit Count: 11

Registration Number: NCT00458237

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients

Phase 4

Completed

Conditions: Renal Transplantation

First Posted Date: 2007-03-07

Last Posted Date: 2007-11-02

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 15

Registration Number: NCT00443937

Locations: 🇩🇪
Charité-Universitätsmedizin, Berlin, Germany

Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment

Phase 2

Completed

Conditions: Leukemia
Lymphoma
Lymphoproliferative Disorder

Interventions: Drug: Everolimus

First Posted Date: 2007-02-19

Last Posted Date: 2019-10-22

Lead Sponsor: Mayo Clinic

Target Recruit Count: 277

Registration Number: NCT00436618

Locations: 🇺🇸
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
🇺🇸
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

Safety of Everolimus and Pemetrexed in Lung Cancer Patients

Phase 1

Completed

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Everolimus
Drug: Pemetrexed

First Posted Date: 2007-02-13

Last Posted Date: 2020-12-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 48

Registration Number: NCT00434174

Locations: 🇩🇪
Novartis Investigative Site, Koeln, Germany

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