Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2 portion will commence.

Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there is no option for patients receiving placebo to cross-over to IPI-926).

IPI 926 is an inhibitor of the Hedgehog Pathway. IPI-926 in combination with gemcitabine may improve therapeutic outcomes in patients with pancreatic cancer. Infinity is conducting a Phase 1b/2 clinical trial to evaluate the safety and efficacy of IPI-926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer.

Inclusion Criteria:

• 18 years of age
• Pathologically confirmed metastatic pancreatic adenocarcinoma
• At least 1 radiologically evaluable metastatic lesion (RECIST 1.1).
• ECOG 0 or 1
• Life expectancy ≥3 months.
• All women of child bearing potential, all sexually active male patients, and partners of patients must agree to use adequate methods of birth control
• Ability to adhere to the study visit schedule
• Voluntarily signed an informed consent form

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