BioCentury
ARTICLE | Clinical News

Cabozantinib: Phase III ongoing

September 12, 2016 7:00 AM UTC

An IDMC recommended continuation of the double-blind, placebo-controlled, international Phase III CELESTIAL trial evaluating 60 mg oral cabozantinib once daily in patients with advanced HCC who have received prior Nexavar sorafenib therapy. The IDMC met after 50% of the events relating to the primary OS endpoint had occurred. A second interim analysis is planned after 75% of events have occurred. Exelixis said 621 events provide the study with 90% power to detect a 32% increase in OS at the final analysis. The trial is enrolling about 760 patients; the company declined to disclose the number of patients already enrolled. ...