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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
-

Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma

Phase 2
Completed
Conditions
Neoplasm Metastases
Renal Cell Carcinoma
Interventions
First Posted Date
2007-11-09
Last Posted Date
2016-04-21
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
72
Registration Number
NCT00556049
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center', Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

Phase 1
Completed
Conditions
Stomach Neoplasms
Interventions
First Posted Date
2007-11-09
Last Posted Date
2011-12-19
Lead Sponsor
Pfizer
Target Recruit Count
34
Registration Number
NCT00555672
Locations
🇪🇸

Pfizer Investigational Site, Madrid, Spain

Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

Phase 1
Completed
Conditions
Stomach Neoplasms
Interventions
First Posted Date
2007-11-08
Last Posted Date
2013-01-14
Lead Sponsor
Pfizer
Target Recruit Count
76
Registration Number
NCT00555620
Locations
🇰🇷

Pfizer Investigational Site, Seoul, Korea, Republic of

Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer

Phase 1
Completed
Conditions
Stomach Neoplasms
Interventions
First Posted Date
2007-11-04
Last Posted Date
2015-03-13
Lead Sponsor
Pfizer
Target Recruit Count
27
Registration Number
NCT00553696
Locations
🇯🇵

Saku Central Hospital, GI Devision, Saku, Nagano, Japan

🇯🇵

Aichi cancer center central hospital / Medical Oncology, Nagoya, Aichi, Japan

🇯🇵

Shizuoka Cancer Center, Suntougun, Shizuoka, Japan

Bevacizumab in Multiple Phase I Combinations

First Posted Date
2007-10-15
Last Posted Date
2020-06-30
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
343
Registration Number
NCT00543504
Locations
🇺🇸

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

Randomized Multicenter Trial With SU11248 Evaluating Dosage,Tolerability,Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor

Phase 2
Completed
Conditions
Platinum Refractory Epithelial Ovarian Cancer
Primary Cancer of the Peritoneum
Cancer of the Fallopian Tube
Interventions
First Posted Date
2007-10-12
Last Posted Date
2014-03-07
Lead Sponsor
AGO Study Group
Target Recruit Count
73
Registration Number
NCT00543049
Locations
🇩🇪

Malterser-Krankenhaus Bonn-Rhein/Sieg, Frauenklinik, Bonn, Germany

🇩🇪

Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik für Frauenheilkunde und Geburtshilfe, Dresden, Germany

🇩🇪

Universitätsklinikum, Universitätsfrauenklinik, Ulm, Germany

and more 12 locations

Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer

Phase 2
Completed
Conditions
Kidney Cancer
First Posted Date
2007-10-08
Last Posted Date
2021-02-21
Lead Sponsor
UNICANCER
Target Recruit Count
92
Registration Number
NCT00541008
Locations
🇫🇷

Hopital Saint Michel, Paris, France

🇫🇷

CHU de la Timone, Marseille, France

🇫🇷

Centre Paul Papin, Angers, France

and more 19 locations

Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI

Not Applicable
Completed
Conditions
Kidney (Renal Cell) Cancer
Kidney Neoplasms
Carcinoma, Renal Cell
Interventions
Procedure: FDG PET CT
Procedure: DCE MRI
Drug: F-18 Fluoro-deoxi-glucose
Drug: Gadolinium-DTPA
Drug: Sunitinib
First Posted Date
2007-09-28
Last Posted Date
2017-06-14
Lead Sponsor
Stanford University
Target Recruit Count
17
Registration Number
NCT00537056
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

SUTENT (SUNITINIB, SU11248)in Patients With Recurrent or Progressive Glioblastoma Multiforme

Phase 2
Conditions
Glioblastoma Multiforme
Interventions
First Posted Date
2007-09-26
Last Posted Date
2010-08-30
Lead Sponsor
Medical University Innsbruck
Target Recruit Count
70
Registration Number
NCT00535379
Locations
🇦🇹

LKH Feldkirch, Feldkirch, Austria

🇦🇹

LNK Wagner-Jauregg, Linz, Austria

🇩🇪

University Hospital of Bonn, Bonn, Nordrhein-Westfalen, Germany

and more 7 locations

Sunitinib in Treating Patients With Locally Advanced Bladder Cancer

Phase 2
Completed
Conditions
Bladder Cancer
Interventions
First Posted Date
2007-09-10
Last Posted Date
2019-04-16
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
9
Registration Number
NCT00526656
Locations
🇺🇸

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

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