J1013: A Phase II Study of Gemcitabine and nab-Paclitaxel in Combination with GDC-0449 (Hedgehog Inhibitor) in Patients with Previously Untreated Metastatic Adenocarcionoma of the Pancreas
To determine the benefits of using GDC-0449(Hedgehog inhibitor) in combination with Gemcitabine and nab-Paclitaxel in pateints with Metastatic Pancreatic Cancer.
Metastatic pancreatic cancer-No previous radiation, surgery or chemotherapy or investigational therapy for treatment of metastatic disease- radiation, chemotherapy or investigation therapy in the adjuvant setting should be completed 3 weeks before starting treatment- good physical condition with good blood counts and organ function-must be willing to use 2 typse of birth control-patients must not be on therapuetic coumadin
Patients will receive combination Gemcitabine + nab-Paclitaxel infused(IV) over 30 minutes each, once a week for 3 weeks with 1 week off (4 weeks or 1 cycle)- Cycle 2 Day will be the first dose of GDC-0449 to be taken daily for 28 days.
09/19/2014 04:03 AM