- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03374852
CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
A Phase II Open-Label Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer and Good Performance Status
Study Overview
Status
Conditions
Intervention / Treatment
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) Objectives:
- To assess the safety of CPI-613 + mFOLFIRINOX combination in patients with locally advanced pancreatic cancer.
- To collect tissue specimens for future correlative studies
- To estimate median progression free survival (PFS) when CPI- 613 is used in combination with mFOLFIRINOX, in patients with locally advanced pancreatic cancer.
- To estimate the percent resected when CPI-613 is used in combination with mFOLFIRINOX in patients with locally advanced pancreatic cancer
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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
|
500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port
mFOLFIRNOX (given immediately after CPI-613 administration):
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Enrollment to death
|
Overall survival defined as the interval between enrollment and death.
|
Enrollment to death
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: 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
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jordan Winter, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 18P.087
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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