Everolimus

Generic Name
Everolimus
Brand Names
Afinitor, Votubia, Zortress
Drug Type
Small Molecule
Chemical Formula
C53H83NO14
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
-

Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients

First Posted Date
2014-06-02
Last Posted Date
2020-12-19
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
37
Registration Number
NCT02152943
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

🇺🇸

MD Anderson in Katy, Houston, Texas, United States

🇺🇸

MD Anderson in Sugar Land, Sugar Land, Texas, United States

and more 2 locations

Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer

First Posted Date
2014-05-21
Last Posted Date
2022-04-04
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
35
Registration Number
NCT02143726
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

Nebraska Methodist Hospital, Omaha, Nebraska, United States

🇺🇸

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

and more 18 locations

LDE225 + Everolimus in Advanced Gastroesophageal Adenocarcinoma

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-05-15
Last Posted Date
2020-06-11
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
25
Registration Number
NCT02138929
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer

First Posted Date
2014-05-14
Last Posted Date
2021-01-28
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
37
Registration Number
NCT02137837
Locations
🇺🇸

St. Patrick Hospital, Missoula, Montana, United States

🇺🇸

Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States

🇺🇸

Clackamas Radiation Oncology Center, Clackamas, Oregon, United States

and more 220 locations

Belatacept for Renal Transplant Recipients With Delayed Graft Function

Early Phase 1
Terminated
Conditions
Interventions
First Posted Date
2014-05-09
Last Posted Date
2021-09-23
Lead Sponsor
Ohio State University
Target Recruit Count
8
Registration Number
NCT02134288
Locations
🇺🇸

The Ohio State Universtiy Wexner Medical Center, Columbus, Ohio, United States

The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients

First Posted Date
2014-05-09
Last Posted Date
2018-12-10
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
3
Registration Number
NCT02134899
Locations
🇫🇷

Bicêtre Hospital, Le Kremlin-Bicêtre, France

Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-04-29
Last Posted Date
2021-05-04
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
38
Registration Number
NCT02125084
Locations
🇺🇸

Tennessee Oncology, Chattanooga, Tennessee, United States

🇺🇸

Tennessee Oncology PLLC, Nashville, Tennessee, United States

🇺🇸

Florida Cancer Specialists, Fort Myers, Florida, United States

and more 2 locations

BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-04-28
Last Posted Date
2022-02-03
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
164
Registration Number
NCT02123823
Locations
🇰🇷

National Cancer Center, Goyang, Korea, Republic of

🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

🇦🇹

LKH-Univ. Hospital Graz, Graz, Austria

and more 35 locations

Eribulin Mesylate and Everolimus in Treating Patients With Triple-Negative Metastatic Breast Cancer

First Posted Date
2014-04-22
Last Posted Date
2022-07-05
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
27
Registration Number
NCT02120469
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

🇺🇸

City of Hope Rancho Cucamonga, Rancho Cucamonga, California, United States

🇺🇸

South Pasadena Cancer Center, South Pasadena, California, United States

REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-04-15
Last Posted Date
2019-02-28
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
78
Registration Number
NCT02115113
Locations
🇮🇹

Novartis Investigative Site, Napoli, Italy

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