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COMPLETEDPHASE1/PHASE2

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

A Phase II/I Open-Label Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer and Good Performance Status

NCT03699319•David Bajor, MD

View on ClinicalTrials.gov

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.

Detailed Description

This is a single-arm study of participants with locally advanced pancreatic ductal adenocarcinoma evaluating combination CPI-613 with modified FOLFIRINOX, with the addition of a dose escalation cohort to assess safety. All study participants will get the same study intervention, which includes the best available treatment for locally advanced pancreatic cancer, plus an experimental therapy. The standard therapy is called mFOLFIRINOX, which is a combination of three chemotherapy drugs (Oxaliplatin, Irniotecan and 5-flurouracil) and one additional vitamin derivative (Folinic acid). The experimental drug is CPI-613, which inhibits energy production in cells, and early studies suggest that pancreatic cancer cells may be especially sensitive. 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. Based on new data, the study team will also attempt to identify a new maximum tolerated dose (MTD) of CPI-613 in a phase 1 open-label dose-regimen finding study. The objectives of the Standard Dose Cohort are to determine the safety and efficacy of CPI-613, in combination with mFOLFIRINOX for locally advanced pancreatic cancer. The objectives of the Dose Escalation Cohort is to determine a new maximum-tolerated dose (MTD) of CPI-613 when given in combination with mFOLFIRINOX.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have histologically or cytologically confirmed pancreatic adenocarcinoma.
•Participants must have locally advanced (including unresectable or borderline resectable) pancreatic cancer based on CT or MRI imaging (pancreas protocol CT of the abdomen and pelvis if possible, MRI with contrast or CT with oral and IV contrast in the absence of a pancreas protocol CT scan, CT of the chest with or without contrast) as determined by the PI or Co-investigators. Participants with contrast allergies may be permitted without contrast scans if approved by the PI or Co-Investigators for safety reasons.
•Eastern Cooperative Oncology Group (ECOG) Performance status being 01 within 1 week of planned start of therapy.
•Participants must have normal organ and marrow function as defined below \< 2 weeks must be:
•* Adequate hematologic (white blood cell \[WBC\] \>= 3500 cells/mm3; platelet count \>= 100,000 cells/mm3; absolute neutrophil count \[ANC\] \>=1500 cells/mm3; and hemoglobin \>=8 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.
•Expected survival \>=3 months in the view of the PI or investigators.
•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.
+3 more criteria

Exclusion Criteria

•Participants with endocrine or acinar pancreatic carcinoma.
•Participants with resectable pancreatic cancer.
•Participants with metastatic pancreatic cancer based on imaging.
•Participants who have received prior surgical or medical treatment for pancreatic cancer.
•Participants 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.
•Pregnant women or breast feeding women, or women of child-bearing potential not using reliable means of contraception are excluded from this study because the teratogenic or abortifacient effects of CPI-613 is unknown. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CPI-613, breastfeeding should be discontinued if the mother is treated with CPI-613. These potential risks may also apply to other agents used in this study.
•Fertile men unwilling to practice contraceptive methods during the study period.
•Participants with a life expectancy less than 3 months.
•Participants with a serious medical illness that would potentially increase participants' risk for toxicity
•Participants with any active uncontrolled bleeding, and any participnats with a bleeding diathesis (e.g., active peptic ulcer disease).
+3 more criteria

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

December 7, 2018

Primary Completion Date

September 23, 2024

Completion Date

September 23, 2024

Last Updated

January 23, 2025

Enrollment

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

CPI 613

DRUG

Oxaliplatin

DRUG

Irinotecan

DRUG

5-flurouracil

DRUG

Folinic acid

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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