Conditions: Basal Cell Carcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 229
Healthy volunteers: no

Brief summary:
This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.

Detailed description:

Arms:
arm 1: Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up arm 2: Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up

Interventions: intervention 1: Vismodegib intervention 2: Placebo
Intervention descriptions: intervention 1: Vismodegib 150 mg hard gelatin capsule orally once daily intervention 2: Vismodegib placebo orally once daily

Protocol document: