EXELIXIS INITIATES PHASE II TRIAL OF XL647 FOR LUNG CANCER

Exelixis has begun a Phase II trial of XL647, an orally bioavailable small molecule inhibitor of the HER2, EGF, VEGF and EphB4 receptor tyrosine kinases (RTKs). Although these individual RTKs are already targets for currently approved therapies, XL647 was designed to potently inhibit all three targets simultaneously. The trial will be conducted in patients with advanced non-small-cell lung cancer who have not previously been treated with chemotherapy.

The multicenter, open-label study will be conducted at up to 15 clinical sites and will follow a two-stage enrollment strategy. The primary objectives of the study are to determine the response rate of subjects treated with XL647 and to evaluate the safety and tolerability of XL647. Secondary objectives include assessment of progression-free survival, duration of response and overall survival, and characterization of pharmacokinetic and pharmacodynamic parameters of the drug.