CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

December 7, 2018

Primary Completion Date

September 23, 2024

Study Completion Date

September 23, 2024

Conditions
Pancreatic Cancer
Interventions
DRUG

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"

DRUG

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)"

DRUG

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)"

DRUG

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)"

DRUG

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)"

Trial Locations (1)

44106

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

David Bajor, MD

OTHER

NCT03699319 - CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer | Biotech Hunter | Biotech Hunter