Sunitinib in Soft Tissue 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Open-label, Non-randomized Trial of Sunitinib in Certain Subtypes of Soft Tissue Sarcomas|
- Clinical response rate [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Drug administered PO daily for 42 days
Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.
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.
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Robert N Taub, MD, PhD||Columbia University|