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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 in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Advanced Solid Tumors

Phase 1
Completed
Conditions
Adult Solid Neoplasm
Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Carcinoma
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions
Other: Computed Tomography
Other: Fluorothymidine F-18
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Positron Emission Tomography
Drug: Sunitinib Malate
First Posted Date
2007-07-11
Last Posted Date
2017-10-10
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
25
Registration Number
NCT00499135
Locations
🇺🇸

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

Sunitinib in Treating Patients With Recurrent Malignant Gliomas

Phase 2
Completed
Conditions
Adult Anaplastic Astrocytoma
Adult Giant Cell Glioblastoma
Adult Mixed Glioma
Adult Gliosarcoma
Adult Diffuse Astrocytoma
Adult Glioblastoma
Adult Oligodendroglioma
Adult Pineal Gland Astrocytoma
Interventions
Drug: sunitinib malate
Other: pharmacological study
First Posted Date
2007-07-11
Last Posted Date
2016-02-29
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
31
Registration Number
NCT00499473
Locations
🇺🇸

Ohio State University Medical Center, Columbus, Ohio, United States

A Phase I/II Study of Sunitinib and Dacarbazine

Phase 1
Terminated
Conditions
Melanoma
Interventions
First Posted Date
2007-07-04
Last Posted Date
2011-02-23
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
11
Registration Number
NCT00496223
Locations
🇺🇸

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

Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor

First Posted Date
2007-07-03
Last Posted Date
2012-10-18
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
204
Registration Number
NCT00495872
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

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

Phase 2
Terminated
Conditions
Liver Cancer
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)

Phase 2
Terminated
Conditions
Renal Cell Carcinoma
Interventions
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
Intraocular Melanoma
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

Phase 2
Terminated
Conditions
Malignant Conjunctival Neoplasm
Intraocular Melanoma
Interventions
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
Breast Cancer
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

A Study of Neoadjuvant Sutent for Patients With Renal Cell Carcinoma

Phase 2
Terminated
Conditions
Renal Cell Carcinoma
Interventions
First Posted Date
2007-05-31
Last Posted Date
2015-12-09
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
3
Registration Number
NCT00480935
Locations
🇨🇦

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

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