GDC-0449 will be evaluated in approximately 100 patients with ovarian cancer in second or third complete remission in a randomized, placebo-controlled, double-blind, multi-center Phase II trial.
Patients will be randomized in a 1:1 ratio to receive either GDC-0449 or a placebo comparator and will be stratified based on whether their cancer is in a second or third complete remission. The primary endpoint of the trial is progression-free survival. Secondary outcome measures include overall survival, measurement of Hedgehog ligand expression in archival tissue and number and attribution of adverse events.
Under the collaboration agreement, Curis will receive a $3 million cash payment from Genentech. Genentech and Roche collaborate on the clinical development and commercialization of GDC-0449. Curis is eligible to receive cash payments upon successful achievement of certain clinical development and regulatory approval milestones and royalties upon commercialization of GDC-0449.
Dan Passeri, president and CEO of Curis, said: Genentech designed this Phase II trial to investigate if GDC-0449 may help delay tumor re-growth following clinical remission of cancer after second-line chemotherapy treatment for recurrent disease. We are hopeful that GDC-0449 may one day provide an additional therapy to existing treatment options for ovarian cancer patients, and we look forward to providing further updates on this program in the future.