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
-

Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium

First Posted Date
2012-09-07
Last Posted Date
2016-12-15
Lead Sponsor
Gaetano Ciancio
Target Recruit Count
32
Registration Number
NCT01680861
Locations
🇺🇸

University of Miami, Miami, Florida, United States

Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors

First Posted Date
2012-09-05
Last Posted Date
2020-03-30
Lead Sponsor
Federation Francophone de Cancerologie Digestive
Target Recruit Count
74
Registration Number
NCT01678664
Locations
🇫🇷

Hôpital Trousseau, Tours, France

🇫🇷

Hôpital Avicenne, Bobigny, France

🇫🇷

Hôpital Côte de Nacre, Caen, France

and more 15 locations

A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2012-09-03
Last Posted Date
2014-01-28
Lead Sponsor
Seagen Inc.
Target Recruit Count
4
Registration Number
NCT01677390
Locations
🇺🇸

Stanford Cancer Center, Stanford, California, United States

🇺🇸

Rocky Mountain Cancer Centers - Midtown, Denver, Colorado, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 5 locations

S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

First Posted Date
2012-08-28
Last Posted Date
2023-12-20
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
1939
Registration Number
NCT01674140
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

Aria Health-Torresdale Campus, Philadelphia, Pennsylvania, United States

🇺🇸

Riverside Methodist Hospital, Columbus, Ohio, United States

and more 1445 locations

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

First Posted Date
2012-08-20
Last Posted Date
2022-08-09
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
821
Registration Number
NCT01668784
Locations
🇫🇷

Local Institution - 0006, Vandoeuvre-lès-Nancy, Lorraine, France

🇮🇹

Local Institution - 0102, Rozzano, Italy

🇫🇷

Local Institution - 0007, Lyon Cedex, France

and more 73 locations

Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma

First Posted Date
2012-08-15
Last Posted Date
2021-10-26
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
56
Registration Number
NCT01665768
Locations
🇺🇸

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population

First Posted Date
2012-08-13
Last Posted Date
2012-08-13
Lead Sponsor
MARIO ABBUD FILHO
Target Recruit Count
80
Registration Number
NCT01663805
Locations
🇧🇷

Instituto de Urologia e Nefrologia, São José do Rio PReto, São Paulo, Brazil

SARC016: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath Tumors

First Posted Date
2012-08-09
Last Posted Date
2019-03-06
Lead Sponsor
Sarcoma Alliance for Research through Collaboration
Target Recruit Count
25
Registration Number
NCT01661283
Locations
🇺🇸

Ann and Robert Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

🇺🇸

Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 9 locations

Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors

Phase 4
Completed
Conditions
Interventions
First Posted Date
2012-07-30
Last Posted Date
2016-08-16
Lead Sponsor
Hospital do Rim e Hipertensão
Target Recruit Count
47
Registration Number
NCT01653041
Locations
🇧🇷

Hospital do Rim e Hipertensão, São Paulo, Brazil

Study of Everolimus Treatment in Newly-diagnosed Patients With Advanced Gastrointestinal Neuroendocrine Tumors

First Posted Date
2012-07-24
Last Posted Date
2019-09-03
Lead Sponsor
Hellenic Cooperative Oncology Group
Target Recruit Count
25
Registration Number
NCT01648465
Locations
🇬🇷

Dept of Medical Oncology, 251 General Airforce Hospital, Athens, Greece

🇬🇷

2nd Dept of Internal Medicine, Propaedeutic, University Hospital "Attikon", Athens, Greece

🇬🇷

Division of Oncology, Dept of Internal Medicine, University Hospital of Patras, Patra, Greece

and more 9 locations
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