Finding studies
Finding studies
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Lead
Roswell Park Cancer Institute
With
PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) to axitinib in advanced melanoma. This will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. SECONDARY OBJECTIVES: I. Evaluate toxicity of axitinib as a single agent. II. Determine progression-free survival and overall survival. III. Explore the utility of 3'-deoxy-3'-\[18F\] fluorothymidine-labeled positron emission tomography (FLT-PET) as a predictive marker for response and compare to standard radiographic imaging. TERTIARY OBJECTIVES: I. Examine the prognostic and predictive significance of circulating melanoma tumor cells. II. To examine whether functionally relevant polymorphisms in axitinib-related genes (vascular endothelial growth factor receptor \[VEGFR\] 1, VEGFR2 and VEGFR3) correlate with efficacy and toxicity of axitinib in advanced melanoma. OUTLINE: Patients receive axitinib orally (PO) twice daily (BID). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
