Curis has announced that its collaborator Genentech has indicated that it expects to initiate a Phase II clinical trial of GDC-0449, an orally-administered small molecule hedgehog antagonist, as a maintenance therapy for ovarian cancer patients in second or third complete remission.
Genentech is developing GDC-0449 under a collaboration agreement with Curis and will be the sponsor of this study. 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, and secondary outcome measures include overall survival, the amount of Hedgehog protein expression in archival tissue and tracking of adverse events. Genentech has indicated that it expects to initiate this Phase II trial during the second half of 2008.
Dan Passeri, president and CEO of Curis, said: "GDC-0449 is currently in Phase II testing in first-line metastatic colorectal cancer and Genentech has indicated that it expects to initiate an additional Phase II clinical trial in advanced basal cell carcinoma in the second half of 2008."