Sunitinib in Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00859456|
Recruitment Status : Unknown
Verified November 2012 by Columbia University.
Recruitment status was: Active, not recruiting
First Posted : March 11, 2009
Last Update Posted : November 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Soft Tissue||Drug: Sunitinib||Phase 2|
This is a Phase II, open label, nonrandomized single institution study to determine efficacy and toxicity of sunitinib in certain subtypes of soft tissue sarcomas. Patients are stratified according to sarcoma histology (angiosarcoma vs. hemangioendothelioma vs. Kaposi's sarcoma).
The purpose of this study is to determine the clinical response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent vascular soft tissue sarcoma treated with sunitinib. Secondary objectives will be to 1) To determine 3 month and 6 month progression free survival, defined as patients that are alive and without evidence of progression of disease on reassessment of disease after while being treated; 2) To determine overall survival of patients treated with this regimen; 3) To determine safety and tolerability of sunitinib in this patient population.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label, Non-randomized Trial of Sunitinib in Certain Subtypes of Soft Tissue Sarcomas|
|Study Start Date :||April 2007|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2013|
Drug administered PO daily for 42 days
Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.
- Clinical response rate [ Time Frame: 84 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859456
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Robert N Taub, MD, PhD||Columbia University|