Pancreatic Cancer PCYC-1137-CA

April 11, 2017

Sponsor: Pharmacyclics LLC.

Number: PCYC-1137-CA

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase II/III trial (Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely) to evaluate the efficacy of Ibrutinib in combination with Nab-Paclitaxel and Gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma (the development of secondary malignant growths at a distance from the primary site of cancer).

Who’s eligible:

• The patient must be histologically (tissue microscopically examined) or cytologically (fluid cells microscopically examined) confirmed diagnosis of pancreatic adenocarcinoma. Stage IV (metastatic disease) disease must be diagnosed within six weeks of randomization (randomly assigned by chance to the trial).

• The patient must have adequate hematologic function:
• Absolute neutrophil count (ANC) ≥1.5 x 109/L
• Platelet count ≥100 x 109/L
• Hemoglobin ≥9 g/dL
• The patient must have adequate hepatic (liver) and renal (kidney) function defined as:
• AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases present, 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 (estimates kidney function)  ≥30 mL/min 

• This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.