Clinical trial NCT03374852 (phase 2, status: withdrawn)
Conditions: pancreatic ductal adenocarcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: cpi-613, mfolfirnox
SMILES: OC(=O)CCCCC(CCSCC1=CC=CC=C1)SCC1=CC=CC=C1
Reason stopped: 
    pi left institution on 8/6/2018 and study has been final reported with irb. never opened to
    accrual
  
Eligibility criteria:

        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.