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

NCT03374852 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 18P.087JT 11772
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival defined as the interval between enrollment and death.

  Enrollment to death

Secondary Outcomes (1)

• Progression free survival (PFS)

  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

Study Arms (1)

CPI-613 + mFOLFIRNOX

EXPERIMENTAL

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/m2 given as a 90-min infusion immediately after oxaliplatin, and concurrently with irinotecan (Camptosar). * Irniotecan at 140 mg/m2 given as a 90-min IV infusion via a central venous port via a Yconnector. * Flurouracil (5FU) 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

Drug: CPI-613; Drug: mFOLFIRNOX

Interventions

CPI-613 DRUG

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

CPI-613 + mFOLFIRNOX

mFOLFIRNOX DRUG

mFOLFIRNOX (given immediately after CPI-613 administration):

CPI-613 + mFOLFIRNOX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Cornerstone Pharmaceuticals: collaborator

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Interventions

devimistat

Study Officials

• Jordan Winter, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 15, 2017
• Study Start: August 1, 2018
• Primary Completion: October 5, 2019
• Study Completion: October 1, 2020
• Last Updated: April 29, 2025

Record last verified: 2025-04