A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas

PRIMARY OBJECTIVES: I. To determine the progression-free survival (defined as complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]) assessed at 16 weeks for patients treated with tivozanib. SECONDARY OBJECTIVES: I. Overall response rate (defined as CR + PR). II. Clinical benefit rate (CR + PR + SD). III. Overall survival (up to 2 years beyond progression). IV. Correlation of clinical outcome with antibodies for vascular endothelial growth factor receptor 1 (VEGFR1) and VEGFR2. V. Assess Safety and tolerability. OUTLINE: Patients receive tivozanib orally (PO) daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity, or until discontinuation per patient preference or physician recommendation. After completion of study treatment, patients are followed up every 3 months for 2 years.