Conditions: Stage IV Pancreatic Cancer
Keywords: Newly diagnosed Stage IV Pancreatic Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 217
Healthy volunteers: no

Brief summary:
The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated stage IV pancreatic cancer.

Detailed description:

Arms:
arm 1: OMP-59R5 plus Gemcitabine and Nab-Paclitaxel arm 2: Gemcitabine and Nab-Paclitaxel plus Placebo

Interventions: intervention 1: OMP-59R5 intervention 2: Gemcitabine intervention 3: Placebo intervention 4: Nab-Paclitaxel
Intervention descriptions: intervention 1: OMP-59R5 administered intravenously intervention 2: administered intravenously intervention 3: administered IV intervention 4: administered intravenously

Protocol document: