Conditions: Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 58
Healthy volunteers: no

Brief summary:
This study is for patients who have been diagnosed with soft tissue sarcoma that has spread (metastasized) or that is not eligible for removal by surgery. The purpose of this study is to determine how soft tissue sarcomas respond to treatment with an investigational drug called tivozanib. In some lab and clinical studies, tivozanib has been shown to interfere with the growth of some types of tumors. The study will also evaluate how safe the study treatment is by observing how many and what kind of adverse events (side effects) participants experience.

Detailed description:
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.

Arms:
arm 1: Patients receive tivozanib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: tivozanib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol document: