Evaluate Efficacy of Devimistat in Combination With mFFX in 2nd Line Patients With Metastatic Pancreatic Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed metastatic stage IV adenocarcinoma of the pancreas
• •Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
• •Male and female patients 18 - 75 years of age
• •Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
• •Recurrrence or progression while on FFX therapy.
• •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must agree to use acceptable highly effective contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive(s), intrauterine hormone releasing system (IUS), bilateral tubal occlusion or vasectomized partner) during and for 6 months after last study dose and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
• •Males with female partners (of childbearing potential) and female partners (of childbearing potential) with male partners must agree to use double barrier contraceptive measure (a combination of male condom with either cap, diaphragm or sponge with spermicide) in addition to oral contraception, or avoidance of intercourse during the study and for 6 months after last study dose is received
• •At least 4 weeks from major surgery with resolution of any sequela to date of enrollment
• •Laboratory values ≤2 weeks during screening must be:
• •Adequate hematologic values
• •* Platelet count ≥100,000 cells/mm3 or ≥100 bil/L;
• •* Absolute neutrophil count \[ANC\] ≥1,500 cells/mm3 or ≥1.5 bil/L;
• •* Hemoglobin \>9 g/dL or \>90 g/L
• •Adequate hepatic function
• •* Aspartate aminotransferase \[AST/SGOT\] ≤3x upper normal limit \[UNL\] (≤5xUNL if liver metastasis present)
• •* Alanine aminotransferase \[ALT/SGPT\] ≤3x UNL (≤5x UNL if liver metastasis present)
• •* Bilirubin (≤1.5x UNL); bilirubin ≤ 2.5 x ULN for subjects with Gilbert's syndrome
• •Adequate renal function
• •* Serum creatinine clearance CLcr \> 30 mL/min). (Cockcroft-Gault Formula should be used for CrCl calculation)
• •Adequate coagulation function
• •* International Normalized Ratio or INR must be \<1.5 unless on anticoagulants
• •No evidence of active infection and no serious infection within the past 30 days. Patient must have completed antibiotic course.
• •Mentally competent, ability to understand and willingness to sign the informed consent form and follow protocol requirements