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

Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise

Phase 4

Terminated

Conditions: Disorder Related to Renal Transplantation
Muscle Strength
Exercise, Aerobic

Interventions: Drug: Everolimus

First Posted Date: 2012-03-23

Last Posted Date: 2015-04-28

Lead Sponsor: Josep M Cruzado

Target Recruit Count: 3

Registration Number: NCT01561404

Locations: 🇪🇸
Nephrology Department. Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelone, Spain

Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

Phase 4

Completed

Conditions: Liver Transplantation

Interventions: Drug: Everolimus
Drug: Corticosteroids
Drug: Tacrolimus

First Posted Date: 2012-03-12

Last Posted Date: 2019-05-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 339

Registration Number: NCT01551212

Locations: 🇩🇪
Novartis Investigative Site, Tübingen, Germany

Controlled Level EVERolimus in Acute Coronary Syndromes

Phase 1

Completed

Conditions: Acute Coronary Syndromes

Interventions: Drug: Placebo
Drug: Everolimus

First Posted Date: 2012-02-09

Last Posted Date: 2021-12-03

Lead Sponsor: University of Zurich

Target Recruit Count: 150

Registration Number: NCT01529554

Locations: 🇩🇪
Kerckhoff-Klinik, Department of Cardiology, Bad Nauheim, Germany
🇨🇭
University Hospital Geneva, Geneva, Switzerland
🇩🇪
University Hospital Chartié, Berlin, Germany

and more 5 locations

Single Arm Study of RAD001 as Monotherapy in Treatment in Advanced Cholangiocarcinoma

Phase 2

Conditions: Cholangiocarcinoma

Interventions: Drug: Everolimus

First Posted Date: 2012-02-03

Last Posted Date: 2012-02-03

Lead Sponsor: Ratchavithi Hospital

Target Recruit Count: 40

Registration Number: NCT01525719

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)

Phase 3

Completed

Conditions: Advanced NET of Lung Origin
Advanced NET of GI Origin
Neuroendocrine Tumors

Interventions: Drug: Placebo
Drug: Everolimus
Other: Best suportive care (BSC)

First Posted Date: 2012-02-02

Last Posted Date: 2021-08-05

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 302

Registration Number: NCT01524783

Locations: 🇺🇸
Cedars Sinai Medical Center SC, Los Angeles, California, United States
🇺🇸
Dana Farber Cancer Institute SC, Boston, Massachusetts, United States
🇺🇸
Texas Oncology P A Texas Oncology Amarillo, Dallas, Texas, United States

and more 15 locations

Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL

Phase 1

Completed

Conditions: Acute Lymphoblastic Leukemia

First Posted Date: 2012-02-01

Last Posted Date: 2024-07-18

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 22

Registration Number: NCT01523977

Locations: 🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States
🇺🇸
Seattle Children's Hospital, Seattle, Washington, United States
🇺🇸
UCSF, San Francisco, California, United States

and more 5 locations

PhaseII,Open-label,Pilot Study Evaluating the Safety+Efficacy of Certican ® in the Prevention of Chronic Graft-versus-host Disease+Late Pulmonary Complications After Allogeneic Hematopoietic Cell Transplantation Blood

Phase 2

Completed

Conditions: Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)

Interventions: Drug: Everolimus

First Posted Date: 2012-01-13

Last Posted Date: 2017-02-23

Lead Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Target Recruit Count: 21

Registration Number: NCT01509560

Locations: 🇩🇪
Zentrum für Knochenmark- und Blutstammzelltransplantation,, Wiesbaden, Hessen, Germany

Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors

Phase 1

Terminated

Conditions: Cancer

Interventions: Drug: BEZ235
Drug: Everolimus

First Posted Date: 2012-01-11

Last Posted Date: 2017-08-23

Lead Sponsor: University of Cincinnati

Target Recruit Count: 19

Registration Number: NCT01508104

Locations: 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States

Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer

Phase 2

Terminated

Conditions: Breast Neoplasms
Endocrine Breast Diseases
Neoplasm Metastasis

Interventions: Drug: letrozole
Drug: lapatinib
Drug: everolimus

First Posted Date: 2011-12-26

Last Posted Date: 2022-02-11

Lead Sponsor: University of Maryland, Baltimore

Target Recruit Count: 7

Registration Number: NCT01499160

Locations: 🇺🇸
University of Maryland Marlene & Stewart Greenebaum Cancer Center, Baltimore, Maryland, United States

Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma

Phase 2

Completed

Conditions: Advanced Adult Hepatocellular Carcinoma

Interventions: Drug: Everolimus
Drug: Pasireotide

First Posted Date: 2011-12-08

Last Posted Date: 2016-04-07

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 24

Registration Number: NCT01488487

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States
🇺🇸
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

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