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
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
This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
Stage IV disease diagnosed within 6 weeks of randomization
Adequate hematologic function:
Adequate hepatic and renal function defined as:
PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
KPS ≥70.
Eastern Cooperative Oncology Group (ECOG) 0-1
Exclusion Criteria:
Pittsfield, Massachusetts 01201, United States
Tacoma, Washington 98405, United States
Dresden, Saxony-Anhalt 01307, Germany