Trials / Completed
CompletedNCT00739661
A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vismodegib 150 mg | Vismodegib 150 mg was provided in hard gelatin capsules. |
| DRUG | Placebo to vismodegib | 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. |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2008-08-22
- Last updated
- 2017-06-08
- Results posted
- 2012-04-26
Source: ClinicalTrials.gov record NCT00739661. Inclusion in this directory is not an endorsement.