A Phase II Open-Label Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer and Good Performance Status

Fecha de inicio: 1 de agosto de 2018

Inclusion Criteria: * Cytologically confirmed pancreatic adenocarcinoma * Locally advanced (including unresectable or borderline resectable) pancreatic cancer based on CT imaging, as determined by the PI * Eastern Cooperative Oncology Group (ECOG) performance status being 0-1 within 1 week of planned start of therapy. * Expected survival \>3 months. * Male and female patients 18 to not older than 80 years of age * 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 during the study, unless documentation of infertility exists. * Laboratory values ≤2 weeks must be: * Adequate hematologic (granulocyte count ≥1500/mm3; white blood cell \[WBC\] ≥3500 cells/mm3; platelet count ≥100,000 cells/mm3; absolute neutrophil count \[ANC\] ≥1500 cells/mm3; and hemoglobin ≥9 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. * No evidence of clinically significant active infection and no serious infection within the past month. * Mentally competent, ability to understand and willingness to sign the informed consent form. Exclusion Criteria: * Patients under the age of 18 or older than 80 years of age * Endocrine or acinar pancreatic carcinoma * Resectable pancreatic cancer * Metastatic pancreatic cancer based on imaging * Prior surgical or medical treatment for pancreatic cancer * Patients receiving any other standard or investigational treatment for their cancer with a primary goal of improving survival within the past 2 weeks prior to initiation of CPI-613 treatment. * Serious medical illness that would potentially increase patients' risk for toxicity * Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease). * Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown). * Lactating females. * Fertile men unwilling to practice contraceptive methods during the study period. * Life expectancy less than 3 months. * Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients. * Unwilling or unable to follow protocol requirements. * Active including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction. * Patients with a history of myocardial infarction that is \<3 months prior to registration. * Evidence of active infection, or serious infection within the past month. * Patients with known HIV infection. * Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient.