A Phase II, Open-label, Non-randomized Trial of Sunitinib in Certain Subtypes of Soft Tissue Sarcomas
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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical response rate
Robert N Taub, MD, PhD
United States: Institutional Review Board
|Columbia University Medical Center||New York, New York 10032|