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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
David Bajor, MD
Study ID
NCT03699319
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CPI 613 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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)

Study Details

The purpose of this study is to treat participants with the combination of CPI-613 (the study drug) with FOLFIRINOX (the standard combination of drugs) to determine if it is safe and effective for participants with localized and unresectable pancreatic cancer. This study is specifically for participants who have a pancreatic cancer that is localized and not considered resectable or removable by a surgeon, without additional treatment.

Key Dates

Start date
Dec 7, 2018
Status verified
Nov 2024
Primary completion
Sep 23, 2024
Completion
Sep 23, 2024

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Standard Dose Cohort: CPI-613 + mFOLFIRINOX
    Novel drug and mitochondrial inhibitor, CPI-613 in conjunction with standard-of-care FOLFRINOX. Consists of a Standard Dose Cohort and Dose escalation cohort using a standard 3 + 3 design starting at 750 mg/m\^2 given at a rate of 4 ml/min ("dose level (DL) 2"). Participants receiving a dose of 1000mg/m\^2 will be treated over 2 hours. In the absence of any DLT, the next DL will begin enrollment. If 1 DLT occurs, the DL will be expanded by 3 participants. If \<33% of participants experience a DLT, the next DL will be opened and will proceed in similarly. Only 2 DLs are expected to be studied: 750 mg/m\^2 and 1000 mg/m\^2. Participants may be enrolled in this cohort after the accrual goal of the standard cohort is met but prior to the completion of treatment of all patients in the standard dose cohort Participants experiencing a DLT will be allowed to continue on the study at the standard DL of 500 mg or lower.

Primary Outcome Measure

Overall Survival [ Time Frame: Two years after completion of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106-

Find similar trials in Cleveland, OH

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

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