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 and Combination Chemotherapy as Front-Line Therapy in Treating Patients With Metastatic Rectal Cancer That Cannot Be Removed by Surgery

Phase 2
Withdrawn
Conditions
First Posted Date
2009-07-10
Last Posted Date
2022-08-30
Lead Sponsor
Federation Francophone de Cancerologie Digestive
Registration Number
NCT00936832
Locations
🇫🇷

Hopital Ambroise Pare, Boulogne Billancourt, France

Sunitinib Malate and Exemestane in Treating Postmenopausal Women With Breast Cancer

First Posted Date
2009-07-02
Last Posted Date
2013-08-12
Lead Sponsor
Institut Català d'Oncologia
Target Recruit Count
70
Registration Number
NCT00931450
Locations
🇪🇸

Institut Catala D'Oncologia, l'Hospitalet de Llobregat, Spain

Sunitinib Malate in Refractory Germ Cell Tumors

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2009-06-03
Last Posted Date
2016-04-15
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
5
Registration Number
NCT00912912
Locations
🇺🇸

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

Sunitinib Malate After Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases

First Posted Date
2009-05-29
Last Posted Date
2014-09-29
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
14
Registration Number
NCT00910039
Locations
🇺🇸

Henry Ford Health System, Detroit, Michigan, United States

🇺🇸

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

🇺🇸

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-05-18
Last Posted Date
2016-11-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
471
Registration Number
NCT00903175
Locations
🇺🇸

University of California at Los Angeles Dept. of UCLA (3), Los Angeles, California, United States

🇺🇸

Loyola University Medical Center /Cardinal Bernardin Cancer Cardinal Bernardin Cancer (3), Maywood, Illinois, United States

🇺🇸

Billings Clinic Dept of Billings Clinic(2), Billings, Montana, United States

and more 33 locations

Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction

First Posted Date
2009-05-01
Last Posted Date
2018-07-24
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
12
Registration Number
NCT00891878
Locations
🇺🇸

Memorial Hospital, Carthage, Illinois, United States

🇺🇸

Graham Hospital, Canton, Illinois, United States

🇺🇸

Illinois CancerCare - Havana, Havana, Illinois, United States

and more 178 locations

Neoadjuvant Sunitinib With Paclitaxel/Carboplatin in Patients With Triple-Negative Breast Cancer

First Posted Date
2009-04-24
Last Posted Date
2016-09-07
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
54
Registration Number
NCT00887575
Locations
🇺🇸

Holy Cross Hospital, Ft. Lauderdale, Florida, United States

🇺🇸

Florida Cancer Specialists North, Ft. Myers, Florida, United States

🇺🇸

National Capital Clinical Research Consortium, Bethesda, Maryland, United States

and more 11 locations

A Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

First Posted Date
2009-04-22
Last Posted Date
2015-07-23
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
14
Registration Number
NCT00886132
Locations
🇨🇦

Princess Margaret Hospital, Toronto, Ontario, Canada

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