49
Participants
Start Date
December 7, 2018
Primary Completion Date
September 23, 2024
Study Completion Date
September 23, 2024
CPI 613
"Standard Dose Cohort: CPI-613, 500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port on days 1 and 3 of each cycle, every 2 weeks.~Dose Escalation Cohort: CPI-613, 750-1000 mg/m2 IV infusion at a rate of 3 mL/min via a central venous port on days 1 and 3 of each cycle, every 2 weeks.~Intended treatment protocol is 12 cycles (2 weeks each) or 6 months"
Oxaliplatin
"Administered at 65 mg/m2 given as a 2-hr IV~Part of SOC mFOLFRINOX treatment combination of Oxaliplatin, Irniotecan, 5-flurouracil, and vitamin derivative (Folinic acid)"
Irinotecan
"Administered at 140 mg/m2 given as a 90-min IV infusion) via a Y-connector~Part of SOC mFOLFRINOX treatment combination of Oxaliplatin, Irniotecan, 5-flurouracil, and vitamin derivative (Folinic acid)"
5-flurouracil
"Administered at 400 mg/m2 as bolus followed by a 46-hr infusion at 2400 mg/m2, starting immediately after completion of folinic acid and irinotecan~Part of SOC mFOLFRINOX treatment combination of Oxaliplatin, Irniotecan, 5-flurouracil, and vitamin derivative (Folinic acid)"
Folinic acid
"Administered at 400 mg/m2 given as a 90-min infusion immediately after oxaliplatin~Part of SOC mFOLFRINOX treatment combination of Oxaliplatin, Irniotecan, 5-flurouracil, and vitamin derivative (Folinic acid)"
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland
David Bajor, MD
OTHER