Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)

Inclusion Criteria

• •1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
• •2. Stage IV disease diagnosed within 6 weeks of randomization
• •3. Adequate hematologic function:
• •* Absolute neutrophil count (ANC) ≥1.5 x 109/L
• •* Platelet count ≥100 x 109/L
• •* Hemoglobin ≥9 g/dL
• •4. Adequate hepatic and renal function defined as:
• •* AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases
• •* Alkaline phosphatase \<3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present
• •* Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
• •* Estimated Creatinine Clearance ≥30 mL/min
• •5. PT/INR \<1.5 x ULN and PTT (aPTT) \<1.5 x ULN
• •6. KPS ≥70.
• •7. Eastern Cooperative Oncology Group (ECOG) 0-1