Status:
WITHDRAWN
CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
Cornerstone Pharmaceuticals
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 w...
Detailed Description
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03374852
Start Date
August 1 2018
End Date
October 1 2020
Last Update
April 29 2025
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