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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00739661 |
Purpose
The proposed study is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of GDC-0449 in patients with ovarian cancer in a second or third complete remission. Patients will be randomized in a 1:1 ratio to either GDC-0449 or placebo. Randomization will be stratified based on whether their cancer is in a second or third complete remission.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: GDC-0449 Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of GDC-0449 As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission |
| Enrollment: | 104 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: GDC-0449
Oral repeating dose
|
| 2: Placebo Comparator |
Drug: placebo
Oral repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
| Study ID Numbers: | SHH4489g |
| Study First Received: | August 21, 2008 |
| Last Updated: | January 21, 2010 |
| ClinicalTrials.gov Identifier: | NCT00739661 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Systemic Hedgehog Hedgehog Pathway Inhibitor |
|
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |