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

• Status: Withdrawn
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborator: Rafael Pharmaceuticals Inc.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.