Conditions: Metastatic Cancer Pancreas
Allocation: RANDOMIZED | Intervention model: 
Enrollment: 3
Healthy volunteers: no

Brief summary:
This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel followed by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of overall survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated with anticancer therapies.

Detailed description:

Arms:
arm 1: PF-03084014 in combination with gemcitabine and nab-paclitaxel arm 2: PF-03084014 in combination with gemcitabine and nab-paclitaxel arm 3: Gemcitabine plus nab-Paclitaxel

Interventions: intervention 1: PF-03084014 intervention 2: Gemcitabine intervention 3: Nab-paclitaxel intervention 4: PF-03084014 intervention 5: Gemcitabine intervention 6: Nab-paclitaxel intervention 7: Gemcitabine intervention 8: Nab-paclitaxel
Intervention descriptions: intervention 1: Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Doses: 100 -150 mg BID intervention 2: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2. intervention 3: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2. intervention 4: Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Phase 2 dose will be the recommended phase 2 dose defined in phase 1. intervention 5: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2. intervention 6: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2. intervention 7: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2. intervention 8: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.

Protocol document: