Table 4.
Study Title | Primary Endpoint | Enrollment (No.) | Estimated Completion Date |
---|---|---|---|
Phase 2 Multicenter, Single-Arm, Two-Cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma | Overall response rate | 15 | December 2012 |
Phase 2 Multicenter, Open-Label, Two-Cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Operable Basal Cell Carcinoma (BCC) | Complete clearance rate (CCR) and durable complete clearance rate (DCCR) of target nodular BCC lesions at time of excision | 49 | December 2012 |
Randomized Phase 2 Multicenter Trial Evaluating the Efficacy and Safety of a Systemic Hedgehog Pathway Antagonist (GDC-0449) in Patients With Basal Cell Nevus Syndrome (BCNS) | Reduction of new surgically eligible BCCs in BCNS patients during months 3–18 of ingestion of vismodegib 150 mg/day | 41 | March 2013 |
Single-Arm, Open-label, Phase 2 Multicenter Study to Assess the Safety of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma (BCC) | Incidence of adverse events | 150 | September 2013 |
Data from ClinicalTrials.gov.