Conditions: Basal Cell Carcinomas
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9
Healthy volunteers: no

Brief summary:
This study is a single site double blinded Phase II study to evaluate the chemopreventative effectiveness of vismodegib in the treatment of subjects at high risk for developing basal cell carcinomas (BCC).

Detailed description:
The primary objective of this study will be to determine if vismodegib pulse therapy will significantly reduce the incidence of newly diagnosed basal cell carcinomas (BCC) in high risk individuals when compared with placebo, as measured by the incidence of biopsy confirmed BCC over a 24 month period.

The secondary objective will be to determine that there will be no difference in the incidence of newly diagnosed squamous cell carcinomas (SCC) in the same subjects receiving vismodegib treatment when compared with placebo, as measured by the incidence of biopsy confirmed SCC over the same 24 month period.

Arms:
arm 1: receive 150 mg of oral placebo daily for a period of 2 months arm 2: receive 150 mg of vismodegib daily for a period of 2 months

Interventions: intervention 1: Vismodegib intervention 2: Placebo
Intervention descriptions: intervention 1: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months. intervention 2: Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.

Protocol document: