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A Phase II Study of GDC-0449 as Maintenance Therapy in Patients with Ovarian Cancer in Second or Third Complete Remission
[Protocol 09-059]
- Full 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 SECOND OR THIRD COMPLETE REMISSION
- Purpose :
The purpose of this study is to determine if the investigational drug GDC-0449 can reduce the risk of recurrence of ovarian, fallopian tube, or primary peritoneal cancer in women who have achieved a second or third remission. GDC-0449 works by inhibiting a signaling pathway called the Hedgehog pathway, which promotes the growth of cancer cells. It is a pill which is taken orally.
Patients will be randomly assigned to receive with GDC-0449 or a placebo.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have ovarian, fallopian tube, or primary peritoneal cancer in second or third remission.
- No more than 14 weeks may have passed since completion of prior chemotherapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact the office of Dr. Paul Sabbatini at 212-639-6423.
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