Phase 2 trial of GDC-0449 for the treatment of operable basal cell carcinoma (BCC)

Curis, Inc. announced that its collaborator Genentech, a member of the Roche Group, has initiated a Phase 2 trial of GDC-0449 for patients with operable basal cell carcinoma (BCC).  This trial will evaluate GDC-0449 in approximately 50 patients with operable nodular BCC in a U.S.-based, open label, two-cohort clinical trial. All patients will receive a 150mg daily oral dose of GDC-0449 for 12 weeks. The primary outcome measures of the trial are as follows:

Cohort 1: The rate of complete histological clearance of the target nodular BCC lesions at the time of tumor excision (which may occur up to 12 weeks following initiation of treatment).

Cohort 2: The rate of durable complete clearance of target nodular BCC lesions at the time of excision (which may occur up to 36 weeks following initiation of treatment).

GDC-0449 is an orally-administered small molecule Hedgehog Pathway Inhibitor, being developed as a single-agent therapy for the treatment of BCC, as well as other types of cancers.

For more information call (617) 503-6500 or visit www.curis.com.