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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
-

Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery

Phase 3
Completed
Conditions
Clear Cell Renal Cell Carcinoma
Stage I Renal Cell Cancer AJCC v6 and v7
Stage II Renal Cell Cancer AJCC v7
Stage III Renal Cell Cancer AJCC v7
Interventions
Other: Laboratory Biomarker Analysis
Other: Placebo
Other: Quality-of-Life Assessment
Drug: Sorafenib Tosylate
Drug: Sunitinib Malate
First Posted Date
2006-05-17
Last Posted Date
2022-02-08
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
1943
Registration Number
NCT00326898
Locations
🇺🇸

Grant Medical Center, Columbus, Ohio, United States

🇺🇸

Mount Carmel Health Center West, Columbus, Ohio, United States

🇺🇸

MedStar Franklin Square Medical Center/Weinberg Cancer Institute, Baltimore, Maryland, United States

and more 974 locations

Study of SU11248 in Men With Advanced Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2006-03-07
Last Posted Date
2012-12-19
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
36
Registration Number
NCT00299741
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

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

A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Phase 2
Completed
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2005-12-14
Last Posted Date
2013-02-06
Lead Sponsor
Pfizer
Target Recruit Count
162
Registration Number
NCT00265317
Locations
🇪🇸

Pfizer Investigational Site, Santander, Cantabria, Spain

An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy

Phase 2
Completed
Conditions
Stomach Neoplasms
Interventions
First Posted Date
2005-09-27
Last Posted Date
2015-03-30
Lead Sponsor
Pfizer
Target Recruit Count
78
Registration Number
NCT00226811
Locations
🇨🇳

Pfizer Investigational Site, Taipei, Taiwan

A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2005-06-09
Last Posted Date
2010-05-18
Lead Sponsor
Pfizer
Target Recruit Count
84
Registration Number
NCT00113516
Locations
🇫🇷

Pfizer Investigational Site, Villejuif, France

Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2004-09-27
Last Posted Date
2008-10-16
Lead Sponsor
Pfizer
Target Recruit Count
111
Registration Number
NCT00092001
Locations
🇪🇸

Pfizer Investigational Site, Barcelona, Spain

SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma

Phase 2
Completed
Conditions
Carcinoma, Renal Cell
Interventions
First Posted Date
2004-08-11
Last Posted Date
2010-01-12
Lead Sponsor
Pfizer
Target Recruit Count
61
Registration Number
NCT00089648
Locations
🇺🇸

Pfizer Investigational Site, Dallas, Texas, United States

Treatment With SU11248 in Patients With Neuroendocrine Tumors

Phase 2
Completed
Conditions
Neuroendocrine Tumors
Interventions
First Posted Date
2003-03-24
Last Posted Date
2008-07-21
Lead Sponsor
Pfizer
Target Recruit Count
107
Registration Number
NCT00056693
Locations
🇺🇸

Pfizer Investigational Site, Philadelphia, Pennsylvania, United States

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