Cabozantinib in patients with advanced prostate cancer: results of a phase II randomized discontinuation trial.

ABSTRACT:

Purpose

Cabozantinib (XL184) is an orally bioavailable tyrosine kinase inhibitor with activity against MET and vascular endothelial growth factor receptor 2. We evaluated the activity of cabozantinib in patients with castration-resistant prostate cancer (CRPC) in a phase II randomized discontinuation trial with an expansion cohort.

Patients and methods

Patients received 100 mg of cabozantinib daily. Those with stable disease per RECIST at 12 weeks were randomly assigned to cabozantinib or placebo. Primary end points were objective response rate at 12 weeks and progression-free survival (PFS) after random assignment.

Results

One hundred seventy-one men with CRPC were enrolled. Random assignment was halted early based on the observed activity of cabozantinib. Seventy-tw

SUBMITTER: Smith DC 

PROVIDER: S-EPMC4110249 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature