CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer

Inclusion Criteria

• •Participants must have histologically or cytologically confirmed pancreatic adenocarcinoma.
• •Participants must have locally advanced (including unresectable or borderline resectable) pancreatic cancer based on CT or MRI imaging (pancreas protocol CT of the abdomen and pelvis if possible, MRI with contrast or CT with oral and IV contrast in the absence of a pancreas protocol CT scan, CT of the chest with or without contrast) as determined by the PI or Co-investigators. Participants with contrast allergies may be permitted without contrast scans if approved by the PI or Co-Investigators for safety reasons.
• •Eastern Cooperative Oncology Group (ECOG) Performance status being 01 within 1 week of planned start of therapy.
• •Participants must have normal organ and marrow function as defined below \< 2 weeks must be:
• •* Adequate hematologic (white blood cell \[WBC\] \>= 3500 cells/mm3; platelet count \>= 100,000 cells/mm3; absolute neutrophil count \[ANC\] \>=1500 cells/mm3; and hemoglobin \>=8 g/dL).
• •* Adequate hepatic function (aspartate aminotransferase \[AST/SGOT\] 3x upper normal limit \[UNL\], alanine aminotransferase \[ALT/SGPT\] \<=3x UNL, bilirubin \<=1.5x UNL).
• •* Adequate renal function (serum creatinine \<=2.0 mg/dL or 177 µmol/L).
• •* Adequate coagulation ("International Normalized Ratio" or INR must be \<1.5) unless on therapeutic blood thinners.
• •Expected survival \>=3 months in the view of the PI or investigators.
• •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
• •Fertile men must practice effective contraceptive methods (i.e. surgical sterilization, or a condom used with a spermicide) during the study, unless documentation of infertility exists.
• •No evidence of clinically significant active infection and no serious infection within the past month requiring hospitalization.
• •Participants must have the ability to understand and the willingness to sign a written informed consent document.