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

NCT03699319 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-01-23

No results posted yet for this study

Summary

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.

Conditions

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)

Sponsors & Collaborators

  • David Bajor, MD

    lead OTHER

Principal Investigators

  • David Bajor, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2024-09-23
Completion
2024-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03699319 on ClinicalTrials.gov