A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Oral Vismodegib for the Treatment of Basal Cell Carcinoma Preceding Excision by Mohs Micrographic Surgery

This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.

Inclusion Criteria:

• Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
• Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
• Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements

Exclusion Criteria:

• Prior treatment with vismodegib
• Known hypersensitivity to any of the study drug excipients
• Any metastatic basal cell carcinoma
• Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
• Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
• Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
• Recent, current, or planned participation in another experimental drug study