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Keep this study
Lead
Infinity Pharmaceuticals, Inc.
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.
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
You may not be if
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