Sunitinib

Generic Name
Sunitinib
Brand Names
Sutent, Sunitinib Accord
Drug Type
Small Molecule
Chemical Formula
C22H27FN4O2
CAS Number
557795-19-4
Unique Ingredient Identifier
V99T50803M
Background

Sunitinib is a small-molecule multi-targeted receptor tyrosine kinase (RTK) inhibitor. On January 26, 2006, the agent was formally approved by the US FDA for the indications of treating renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST). For these purposes, sunitinib is generally available as an orally administered formulation. Sunitinib inhibits cellular signaling by targeting multiple RTKs. These include all platelet-derived growth factor receptors (PDGF-R) and vascular endothelial growth factor receptors (VEGF-R). Sunitinib also inhibits KIT (CD117), the RTK that drives the majority of GISTs. In addition, sunitinib inhibits other RTKs including RET, CSF-1R, and flt3.

Indication

Sunitinib is indicated for the following conditions:

Associated Conditions
Gastrointestinal Stromal Tumor (GIST), Renal Cell Carcinoma (RCC), Renal Cell Carcinoma Recurrent, Unresectable, locally advanced Progressive Neuroendocrine Tumors of pancreatic origin, Unresectable, metastatic Progressive Neuroendocrine Tumors of pancreatic origin
Associated Therapies
-

Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2007-07-03
Last Posted Date
2012-03-27
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
33
Registration Number
NCT00495625
Locations
🇺🇸

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)

First Posted Date
2007-06-26
Last Posted Date
2009-04-10
Lead Sponsor
Genentech, Inc.
Target Recruit Count
16
Registration Number
NCT00491738

Sunitinib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Ocular Melanoma

Phase 2
Conditions
First Posted Date
2007-06-21
Last Posted Date
2014-01-10
Lead Sponsor
San Diego Pacific Oncology & Hematology Associates
Target Recruit Count
50
Registration Number
NCT00489944
Locations
🇺🇸

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas, Encinitas, California, United States

Lenalidomide, Sunitinib, and Cyclophosphamide in Treating Patients With Stage IV Eye Melanoma

First Posted Date
2007-06-05
Last Posted Date
2017-03-27
Lead Sponsor
National Institutes of Health Clinical Center (CC)
Target Recruit Count
12
Registration Number
NCT00482911
Locations
🇺🇸

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office, Bethesda, Maryland, United States

Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery

Phase 2
Completed
Conditions
First Posted Date
2007-06-05
Last Posted Date
2024-02-12
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
4
Registration Number
NCT00482755
Locations
🇨🇦

British Columbia Cancer Agency - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

🇨🇦

Edmond Odette Cancer Centre at Sunnybrook, Toronto, Ontario, Canada

Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

First Posted Date
2007-05-24
Last Posted Date
2020-02-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
34
Registration Number
NCT00478426
Locations
🇨🇦

University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

🇺🇸

Loyola University Medical Center, Maywood, Illinois, United States

🇺🇸

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

and more 26 locations

Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas

First Posted Date
2007-05-17
Last Posted Date
2016-01-20
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
53
Registration Number
NCT00474994
Locations
🇺🇸

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

🇺🇸

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States

Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2007-05-09
Last Posted Date
2011-07-25
Lead Sponsor
Pfizer
Target Recruit Count
83
Registration Number
NCT00471276
Locations
🇺🇸

Pfizer Investigational Site, Everett, Washington, United States

Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2007-04-24
Last Posted Date
2016-06-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
61
Registration Number
NCT00465179
Locations
🇺🇸

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

Sunitinib and Gemcitabine in Treating Patients With Pancreatic Cancer or Other Solid Tumors

First Posted Date
2007-04-19
Last Posted Date
2014-02-24
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
37
Registration Number
NCT00462553
Locations
🇺🇸

Case Western Reserve University, Cleveland, Ohio, United States

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