A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer

Exclusion Criteria

• •Islet cell, acinar cell carcinoma, non-adenocarcinoma, (i.e., lymphoma, sarcoma), adenocarcinoma originated from biliary tree or cystadenocarcinoma
• •Prior treatment with chemotherapy for pancreatic cancer.
• •Known central nervous system metastases
• •Inadequate hematologic function
• •Inadequate hepatic function
• •Inadequate renal function
• •External (percutaneous) biliary drain
• •History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
• •Venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation not appropriately anticoagulated or have NCI CTCAE Grade 2 or greater bleeding episode in the 3 weeks prior to administration of IPI-926
• •Concurrent administration of the medications or foods known to inhibit CYP3A activity to a clinically relevant degree
• •Presence of active infection or systemic use of antibiotics within 72 hours of treatment
• •Significant co-morbid condition or disease which in the judgment of the Investigator would place the patient at undue risk or interfere with the study.
• •Known human immunodeficiency virus (HIV) positivity
• •Known hypersensitivity to gemcitabine, IPI-926, or their excipients
• •Pregnant or lactating women