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
Overview
- Phase
- Phase 3
- Intervention
- CPI 613, mFolfirinox
- Conditions
- Pancreatic Cancer Metastatic
- Sponsor
- Cornerstone Pharmaceuticals
- Enrollment
- 528
- Locations
- 73
- Primary Endpoint
- Overall Survival (OS)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed metastatic Stage IV adenocarcinoma of the pancreas
- •No prior treatments for stage IV pancreatic adenocarcinoma (prior adjuvant or neoadjuvant treatment is allowed provided completed \> 6 months prior to disease recurrence)
- •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)
- •Expected survival \>3 months
- •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted 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, at monthly interval (day 1 of every even numbered cycle), at the end of systemic exposure, and at 30 days after the systemic exposure
- •Males with female partners (of childbearing potential) and female partners (of child bearing 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 2 weeks must have elapsed from any prior surgery with resolution of any sequela for randomization
- •Laboratory values ≤2 weeks prior to randomization must be:
Exclusion Criteria
- •Endocrine or acinar pancreatic carcinoma
- •Known cerebral metastases, central nervous system (CNS), or epidural tumor
- •Prior treatment with any chemotherapy for metastatic adenocarcinoma of the pancreas
- •Completion of a gemcitabine-based adjuvant chemotherapy regimen within less than 6 months at the time of screening.
- •Receipt of neoadjuvant or adjuvant FOLFIRINOX therapy if \<6 months prior to disease recurrence
- •Patients with hypersensitivity to devimistat, FFX treatment or any of their excipients
- •Presence of clinically significant abdominal ascites
- •Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of devimistat 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)
Arms & Interventions
CPI-613, mFolfirinox
CPI-613, mFolfirinox CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle. mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 140mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
Intervention: CPI 613, mFolfirinox
Folfirinox
Folfirinox Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.
Intervention: Folfirinox
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: 38 months
Defined as the duration from the date of randomization to the date of death from any cause
Secondary Outcomes
- Progression Free Survival (PFS)(38 months)
- Overall Response Rate (ORR)(38 months)