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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 in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

Phase 2
Completed
Conditions
Uterine Leiomyosarcoma
Recurrent Uterine Sarcoma
Interventions
First Posted Date
2006-09-21
Last Posted Date
2019-07-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
44
Registration Number
NCT00378911
Locations
🇺🇸

Gynecologic Oncology Group, Philadelphia, Pennsylvania, United States

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

Phase 3
Completed
Conditions
Kidney Neoplasms
Interventions
First Posted Date
2006-09-13
Last Posted Date
2018-09-21
Lead Sponsor
Pfizer
Target Recruit Count
674
Registration Number
NCT00375674
Locations
🇨🇴

Instituto Nacional de Cancerologia - ESE, Bogota, Cundinamarca, Colombia

🇮🇪

Beaumont Hospital, Dublin, Ireland

🇮🇱

Assaf Harofeh Medical Center, Zerifin, Israel

and more 110 locations

A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

Phase 3
Completed
Conditions
Breast Neoplasms
Interventions
First Posted Date
2006-09-08
Last Posted Date
2012-09-10
Lead Sponsor
Pfizer
Target Recruit Count
488
Registration Number
NCT00373256
Locations
🇪🇸

Pfizer Investigational Site, Madrid, Spain

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

Phase 3
Terminated
Conditions
Breast Neoplasms
Interventions
First Posted Date
2006-09-07
Last Posted Date
2012-06-25
Lead Sponsor
Pfizer
Target Recruit Count
482
Registration Number
NCT00373113
Locations
🇬🇧

Pfizer Investigational Site, Somerset, United Kingdom

Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2006-09-07
Last Posted Date
2012-12-28
Lead Sponsor
Pfizer
Target Recruit Count
26
Registration Number
NCT00372424
Locations
🇮🇹

Pfizer Investigational Site, Milano, Italy

Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

Phase 3
Terminated
Conditions
Gastrointestinal Stromal Tumor
Interventions
First Posted Date
2006-09-07
Last Posted Date
2011-03-17
Lead Sponsor
Pfizer
Target Recruit Count
69
Registration Number
NCT00372567
Locations
🇬🇧

Pfizer Investigational Site, Manchester, United Kingdom

Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2006-09-07
Last Posted Date
2011-02-24
Lead Sponsor
Pfizer
Target Recruit Count
66
Registration Number
NCT00372775
Locations
🇪🇸

Pfizer Investigational Site, Valencia, Spain

Bevacizumab and Sunitinib in Treating Patients With Solid Tumors

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Drug: sunitinib malate
Biological: bevacizumab
Other: pharmacological study
Other: laboratory biomarker analysis
First Posted Date
2006-07-27
Last Posted Date
2014-02-24
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
60
Registration Number
NCT00357318
Locations
🇺🇸

Cleveland Clinic Foundation, Cleveland, Ohio, United States

🇺🇸

Case Western Reserve University, Cleveland, Ohio, United States

Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer

Phase 2
Completed
Conditions
Carcinoma, Renal Cell
Interventions
First Posted Date
2006-06-20
Last Posted Date
2012-08-31
Lead Sponsor
Pfizer
Target Recruit Count
120
Registration Number
NCT00338884
Locations
🇨🇳

Pfizer Investigational Site, Taipei, Taiwan

Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy

Phase 2
Active, not recruiting
Conditions
Prostate Cancer
Interventions
Drug: LHRH Agonist
Drug: Sunitinib Malate
Procedure: Radical Prostatectomy
First Posted Date
2006-05-24
Last Posted Date
2024-12-05
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
64
Registration Number
NCT00329043
Locations
🇺🇸

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

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