At a glance
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A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission
In Brief
A Phase 2 clinical trial evaluating Vismodegib 150 mg and Placebo to vismodegib for Ovarian Cancer. Completed, enrolled 104 participants.
Detailed Summary
The study was a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of vismodegib (GDC-0449) in patients with ovarian cancer in a second or third complete remission. Patients were randomized in a 1:1 ratio to either vismodegib or placebo. Randomization was stratified based on whether their cancer was in a second or third complete remission.
Study Details
Timeline
Interventions
Vismodegib 150 mg was provided in hard gelatin capsules.
Placebo to vismodegib consisted of the excipients for vismodegib without the active molecule in hard gelatin capsules matching the active drug product in color and size.