NCT01815840

A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Vismodegib	Vismodegib 150 mg hard gelatin capsule orally once daily
DRUG	Placebo	Vismodegib placebo orally once daily

Timeline

• Start date: 2013-04-30
• Primary completion: 2015-08-27
• Completion: 2016-08-31
• First posted: 2013-03-21
• Last updated: 2017-09-28
• Results posted: 2016-08-04

Locations

58 sites across 10 countries: United States, Austria, Canada, France, Germany, Italy, Mexico, Netherlands, Russia, Spain