CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 229 enrolled
Drug / intervention
Vismodegib +1 moredrug
Likely dose
Vismodegib 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01815840
NCT01815840Phase 2Completed

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

Hoffmann-La Roche·interventional·Posted Mar 21, 2013·Updated Sep 28, 2017

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, France, Germany, Italy, Mexico, Netherlands, Russia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 21, 2013
Enrollment StartApr 30, 2013
Primary CompletionAug 27, 2015
Study CompletionAug 31, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.3 years ago

Interventions

Vismodegibdrug

Vismodegib 150 mg hard gelatin capsule orally once daily

Placebodrug

Vismodegib placebo orally once daily