At a glance
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A Randomized, Double-blinded, Regimen-controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas
In Brief
A Phase 2 clinical trial evaluating Vismodegib and Placebo for Basal Cell Carcinoma. Completed, enrolled 229 participants across 58 sites in 10 countries.
Detailed 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.
Study Details
Timeline
Interventions
Vismodegib 150 mg hard gelatin capsule orally once daily
Vismodegib placebo orally once daily