Conditions: Ovarian Cancer
Keywords: Systemic Hedgehog Hedgehog Pathway Inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 104
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study. arm 2: Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.

Interventions: intervention 1: Vismodegib 150 mg intervention 2: Placebo to vismodegib
Intervention descriptions: intervention 1: Vismodegib 150 mg was provided in hard gelatin capsules. intervention 2: 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.

Protocol document: