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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
-
Clinical Trials
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Multimodality Phase II Study in Prostate Cancer

Phase 2
Terminated
Conditions
Prostate Cancer
Interventions
Drug: Docetaxel
Drug: Sunitinib
Radiation: EBXRT
First Posted Date
2008-08-14
Last Posted Date
2015-12-23
Lead Sponsor
Duke University
Target Recruit Count
36
Registration Number
NCT00734851
Locations
🇺🇸

The Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

🇺🇸

Duke University, Durham, North Carolina, United States

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

Sutent + Taxol for Advanced Esophageal Cancer

Phase 2
Completed
Conditions
Esophageal Cancer
Interventions
Drug: Sunitinib malate
Drug: Paclitaxel
First Posted Date
2008-08-08
Last Posted Date
2017-03-16
Lead Sponsor
Hoosier Cancer Research Network
Target Recruit Count
28
Registration Number
NCT00730353
Locations
🇺🇸

Ireland Cancer Center - University Hospitals of Cleveland, Cleveland, Ohio, United States

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Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

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Rush-Presbyterian St. Luke's Medical Center, Chicago, Illinois, United States

and more 12 locations

Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors

Phase 1
Terminated
Conditions
Advanced Cancer
Advanced Solid Tumors
Interventions
Drug: CP-751,871
Drug: Sunitinib
First Posted Date
2008-08-08
Last Posted Date
2014-06-09
Lead Sponsor
Pfizer
Target Recruit Count
45
Registration Number
NCT00729833
Locations
🇺🇸

Pfizer Investigational Site, San Antonio, Texas, United States

Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma

Phase 3
Completed
Conditions
Carcinoma, Renal Cell
Interventions
Drug: Sunitinib
Drug: Pazopanib
First Posted Date
2008-07-23
Last Posted Date
2021-05-13
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
927
Registration Number
NCT00720941
Locations
🇬🇧

Novartis Investigative Site, Swansea, United Kingdom

Sunitinib Before and After Surgery in Treating Patients With Stage IV Kidney Cancer

Phase 2
Conditions
Kidney Cancer
First Posted Date
2008-07-17
Last Posted Date
2014-01-10
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Target Recruit Count
20
Registration Number
NCT00717587
Locations
🇺🇸

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).

Completed
Conditions
Gastrointestinal Stromal Tumors
Interventions
Drug: SUNITINIB MALATE
First Posted Date
2008-07-16
Last Posted Date
2023-04-06
Lead Sponsor
Pfizer
Target Recruit Count
472
Registration Number
NCT00716820

Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)

Completed
Conditions
Carcinoma, Renal Cell
Interventions
Drug: sunitinib malate
First Posted Date
2008-07-16
Last Posted Date
2023-05-03
Lead Sponsor
Pfizer
Target Recruit Count
1674
Registration Number
NCT00716625

Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)

Phase 2
Active, not recruiting
Conditions
Renal Cell Carcinoma
Interventions
Drug: Sunitinib
Procedure: Nephrectomy
First Posted Date
2008-07-15
Last Posted Date
2024-10-04
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
50
Registration Number
NCT00715442
Locations
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Baylor College of Medicine, Houston, Texas, United States

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

Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer

Phase 1
Completed
Conditions
Advanced Solid Tumors
Non Small Cell Lung Cancer
Interventions
Drug: sunitinib
Drug: docetaxel
First Posted Date
2008-07-10
Last Posted Date
2008-11-11
Lead Sponsor
Pfizer
Target Recruit Count
49
Registration Number
NCT00712504
Locations
🇺🇸

Pfizer Investigational Site, Madison, Wisconsin, United States

A Study for Participants With Metastatic Renal Cell Carcinoma

Phase 2
Completed
Conditions
Metastatic Renal Cell Carcinoma
Interventions
Drug: Enzastaurin
Drug: Placebo
Drug: Sunitinib
First Posted Date
2008-07-03
Last Posted Date
2019-09-30
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
17
Registration Number
NCT00709995
Locations
🇵🇱

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Warsaw, Poland

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