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 Treating Patients With Locally Advanced or Metastatic Thyroid Cancer

Phase 2

Completed

Conditions: Head and Neck Cancer

Interventions: Drug: everolimus
Other: laboratory biomarker analysis

First Posted Date: 2010-07-16

Last Posted Date: 2014-12-02

Lead Sponsor: Yonsei University

Target Recruit Count: 40

Registration Number: NCT01164176

Locations: 🇰🇷
Hallym University Sacred Heart Hospital, Anyang, Gyeonggi-do, Korea, Republic of
🇰🇷
National Cancer Center - Korea, Goyang, Korea, Republic of
🇰🇷
Yonsei Cancer Center at Yonsei University Medical Center, Seoul, Korea, Republic of

and more 4 locations

Everolimus and LongActing Octreotide Trial in Polycystic Livers

Phase 2

Completed

Conditions: Polycystic Liver Disease

Interventions: Drug: Octreotide LAR
Drug: Everolimus

First Posted Date: 2010-07-07

Last Posted Date: 2015-06-29

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 44

Registration Number: NCT01157858

Locations: 🇳🇱
Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

Everolimus MICE-regimen in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: cytarabine
Drug: etoposide
Drug: everolimus
Drug: idarubicin
Drug: mitoxantrone hydrochloride

First Posted Date: 2010-06-30

Last Posted Date: 2022-10-26

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 11

Registration Number: NCT01154439

Locations: 🇮🇹
Università La Sapienza, Roma, Italy
🇮🇹
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia, Napoli, Italy
🇮🇹
Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Rome, Italy

and more 2 locations

Everolimus and OSI-906 for Patients With Refractory Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: OSI-906
Drug: Everolimus

First Posted Date: 2010-06-30

Last Posted Date: 2022-05-03

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 18

Registration Number: NCT01154335

Locations: 🇺🇸
Tennessee Oncology, Nashville, Tennessee, United States
🇺🇸
Florida Cancer Specialists, Fort Myers, Florida, United States

Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers

Phase 1

Terminated

Conditions: Cancer
Colon Cancer
Neuroendocrine
Ovarian Cancer

Interventions: Drug: JI-101
Drug: Everolimus

First Posted Date: 2010-06-23

Last Posted Date: 2014-10-06

Lead Sponsor: University of Utah

Target Recruit Count: 19

Registration Number: NCT01149434

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

Safety Study of the Combination of Panitumumab, Irinotecan and Everolimus in the Treatment of Advanced Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal

Interventions: Drug: Panitumumab
Drug: Irinotecan
Drug: Everolimus

First Posted Date: 2010-06-08

Last Posted Date: 2017-11-06

Lead Sponsor: The Queen Elizabeth Hospital

Target Recruit Count: 49

Registration Number: NCT01139138

Locations: 🇦🇺
The Queen Elizabeth Hospital, Adelaide, South Australia, Australia

A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment

Phase 1

Completed

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Lenvatinib
Drug: Everolimus

First Posted Date: 2010-06-03

Last Posted Date: 2019-02-27

Lead Sponsor: Eisai Inc.

Target Recruit Count: 173

Registration Number: NCT01136733

Study in Locally Advanced Squamous Cell Carcinoma of Head and Neck

Phase 2

Terminated

Conditions: Head and Neck Cancer

Interventions: Drug: Placebo
Drug: Everolimus

First Posted Date: 2010-05-31

Last Posted Date: 2020-05-08

Lead Sponsor: University of Chicago

Target Recruit Count: 50

Registration Number: NCT01133678

Locations: 🇺🇸
The University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
NorthShore University Health System, Evanston, Illinois, United States

Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia

Phase 1

Terminated

Conditions: Waldenstrom's Macroglobulinemia

Interventions: Drug: Everolimus
Drug: Rituximab
Drug: Bortezomib

First Posted Date: 2010-05-18

Last Posted Date: 2021-04-23

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 46

Registration Number: NCT01125293

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery

Phase 3

Active, not recruiting

Conditions: Kidney Cancer

Interventions: Other: placebo
Drug: everolimus

First Posted Date: 2010-05-10

Last Posted Date: 2024-08-29

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 1545

Registration Number: NCT01120249

Locations: 🇺🇸
Greenville Health System Cancer Institute-Easley, Easley, South Carolina, United States
🇺🇸
The Mark H Zangmeister Center, Columbus, Ohio, United States
🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States

and more 988 locations

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