A Randomized, Multicenter, Double-blind, Placebo-controlled, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma

• Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.

• Stage IV disease diagnosed within 6 weeks of randomization

• Adequate hematologic function:

‣ Absolute neutrophil count (ANC) ≥1.5 x 109/L

⁃ Platelet count ≥100 x 109/L

⁃ Hemoglobin ≥9 g/dL

• 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

• PT/INR \<1.5 x ULN and PTT (aPTT) \<1.5 x ULN

• KPS ≥70.

• Eastern Cooperative Oncology Group (ECOG) 0-1