Axitinib (AG-013736) in patients with metastatic melanoma: A phase II study

9006 Background: No treatment has extended survival in stage IV melanoma. Melanomas are highly angiogenic and metastatic, express high levels of vascular endothelial growth factor receptors (VEGFRs) 2 and 3 and form vascular-like structures in vivo that may be exploited therapeutically. Axitinib is an oral, potent and selective inhibitor of VEGFRs 1, 2, 3 with preliminary evidence of clinical activity as monotherapy against similarly aggressive pro-angiogenic malignancies, such as metastatic renal cell carcinoma. Methods: 32 patients with ≤1 prior treatment for metastatic disease and ECOG PS 0–1 received single-agent axitinib at a starting dose of 5 mg BID. The primary endpoint was objective response rate (ORR) by RECIST criteria. BP was monitored regularly. Blood samples were also collected before and after therapy to explore pharmacodynamic (PD) and potential PK/PD relationships between clinical response and plasma soluble proteins. Results: The most common treatment-related adverse events (AEs) were fa...