A Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of FOLFIRINOX (FFX) versus Combination of CPI-613 with modified FOLFIRINOX (mFFX) in Patients with Metastatic Adenocarcinoma of the Pancreas

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Pancreatic Cancer
  • Age: Between 18 years - 99 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) No prior treatments for stage IV pancreatic adenocarcinoma (prior adjuvant or neoadjuvant treatment is allowed provided completed > 6 months prior to disease recurrence) 2) At least 2 weeks must have elapsed from any prior surgery with resolution of any sequela for randomization 3) Adult subjects of child bearing potential must agree to use double barrier contraceptive measure, oral contraception or avoidance of intercourse during the study and for 6 months after last study dose is received.

You may not be eligible for this study if the following are true:

  • 1) Endocrine or acinar pancreatic carcinoma 2) Known cerebral metastases, central nervous system (CNS), or epidural tumor 3) Prior treatment with any chemotherapy for metastatic adenocarcinoma of the pancreas 4) Completion of a gemcitabine-based adjuvant chemotherapy regimen within less than 6 months at the time of screening. 5) Receipt of neoadjuvant or adjuvant FOLFIRINOX therapy


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