CPI-613 In Combination With Modified FOLFIRINOX In Patients With Locally Advanced Pancreatic Cancer

Study Overview

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

This study is a single arm, phase II trial, of 45 patients with locally advanced pancreatic ductal adenocarcinoma. The efficacy of the novel drug and mitochondrial inhibitor, CPI-613, in conjunction with standard-of-care FOLFRINOX, as a first-line therapy will be evaluated. Pre-treatment, diagnostic biopsy tissue will be collected when available, and clinical data will be evaluated to determine if the combination results in improved overall survival compared to historical experience.

Primary Objective: 1) To determine if CPI-613 increases overall survival (OS) when used in combination with mFOLFIRINOX, in patients with locally advanced pancreatic cancer. Secondary (Exploratory) Objectives: 1. To assess the safety of CPI-613 + mFOLFIRINOX combination in patients with locally advanced pancreatic cancer. 2. To collect tissue specimens for future correlative studies 3. To estimate median progression free survival (PFS) when CPI- 613 is used in combination with mFOLFIRINOX, in patients with locally advanced pancreatic cancer. 4. To estimate the percent resected when CPI-613 is used in combination with mFOLFIRINOX in patients with locally advanced pancreatic cancer

Pancreatic Ductal Adenocarcinoma

DRUG: CPI-613
DRUG: mFOLFIRNOX

18P.087
JT 11772 (OTHER Identifier) (OTHER: JeffTrial Number)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-12-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-28
First Submitted that Met QC Criteria 2017-12-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-29
First Posted (ACTUAL) 2017-12-15	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CPI-613 + mFOLFIRNOX CPI-613: 500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port mFOLFIRNOX (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2-hr IV infusion via a central venous port * Folinic acid at 400 mg	DRUG: CPI-613 500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port DRUG: mFOLFIRNOX mFOLFIRNOX (given immediately after CPI-613 administration):

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CPI-613 + mFOLFIRNOX

CPI-613: 500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port mFOLFIRNOX (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2-hr IV infusion via a central venous port * Folinic acid at 400 mg

DRUG: CPI-613

500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port

DRUG: mFOLFIRNOX

mFOLFIRNOX (given immediately after CPI-613 administration):

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival	Overall survival defined as the interval between enrollment and death.	Enrollment to death

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival (PFS)	Progression free survival time is defined as time from enrollment until progression or death. The distribution of PFS will be estimated using the Kaplan-Meier method.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Cytologically confirmed pancreatic adenocarcinoma
Locally advanced (including unresectable or borderline resectable) pancreatic cancer based on CT imaging, as determined by the PI
Eastern Cooperative Oncology Group (ECOG) performance status being 0-1 within 1 week of planned start of therapy.
Expected survival >3 months.
Male and female patients 18 to not older than 80 years of age
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device (IUD), oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
Laboratory values ≤2 weeks must be:

Adequate hematologic (granulocyte count ≥1500/mm3; white blood cell [WBC] ≥3500 cells/mm3; platelet count ≥100,000 cells/mm3; absolute neutrophil count [ANC] ≥1500 cells/mm3; and hemoglobin ≥9 g/dL).
Adequate hepatic function (aspartate aminotransferase [AST/SGOT] ≤3x upper normal limit [UNL], alanine aminotransferase [ALT/SGPT] ≤3x UNL, bilirubin ≤1.5x UNL).
Adequate renal function (serum creatinine ≤2.0 mg/dL or 177 μmol/L).
Adequate coagulation ("International Normalized Ratio" or INR must be <1.5) unless on therapeutic blood thinners.
No evidence of clinically significant active infection and no serious infection within the past month.
Mentally competent, ability to understand and willingness to sign the informed consent form.

Patients under the age of 18 or older than 80 years of age
Endocrine or acinar pancreatic carcinoma
Resectable pancreatic cancer
Metastatic pancreatic cancer based on imaging
Prior surgical or medical treatment for pancreatic cancer
Patients receiving any other standard or investigational treatment for their cancer with a primary goal of improving survival within the past 2 weeks prior to initiation of CPI-613 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).
Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown).
Lactating females.
Fertile men unwilling to practice contraceptive methods during the study period.
Life expectancy less than 3 months.
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
Unwilling or unable to follow protocol requirements.
Active including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction.
Patients with a history of myocardial infarction that is <3 months prior to registration.
Evidence of active infection, or serious infection within the past month.
Patients with known HIV infection.
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Cornerstone Pharmaceuticals

Investigators

PRINCIPAL_INVESTIGATOR: Jordan Winter, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record