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Chemotherapy Agent

CPI-613 + FOLFIRINOX for Locally Advanced Pancreatic Cancer

Phase 1 & 2
Waitlist Available
Led By Jeffery Hardacre, MD
Research Sponsored by Jeffrey Hardacre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have locally advanced (including unresectable or borderline resectable) pancreatic cancer based on CT or MRI imaging as determined by the PI or Co-investigators
Participants must have histologically or cytologically confirmed pancreatic adenocarcinoma
Must not have
Participants with endocrine or acinar pancreatic carcinoma
Participants who have received prior surgical or medical treatment for pancreatic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years after completion of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat pancreatic cancer that has not spread and is not able to be removed by surgery.

Who is the study for?
This trial is for adults with pancreatic cancer that can't be surgically removed. They should have a certain level of physical fitness (ECOG 0-1), good organ function, no serious infections recently, and an expected survival of at least 3 months. Women must not be pregnant and agree to contraception; men also need to use birth control if they're fertile.
What is being tested?
The study tests CPI-613 in combination with FOLFIRINOX (a mix of drugs: 5-flurouracil, folinic acid, oxaliplatin, irinotecan) against localized pancreatic cancer that cannot be removed by surgery. The goal is to see if this combo is safe and works better than current treatments.
What are the potential side effects?
Possible side effects include reactions from the drug infusion, fatigue, nausea or vomiting due to chemotherapy drugs like FOLFIRINOX components. There may also be blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pancreatic cancer is advanced but hasn't spread far, as confirmed by scans.
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My cancer is confirmed as pancreatic adenocarcinoma through testing.
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I am a man who can father children and will use birth control during the study, unless I'm infertile.
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I haven't had a serious infection or been hospitalized for one in the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a specific type of pancreatic cancer.
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I have had surgery or medical treatment for pancreatic cancer.
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I do not have any uncontrolled illnesses that could interfere with the study.
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My pancreatic cancer can be surgically removed.
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I am not HIV-positive or not on antiretroviral therapy.
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My pancreatic cancer has spread, as shown by scans.
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I am a man who can father children and will not use birth control during the study.
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I haven't received any cancer treatments aimed at extending my life in the last 2 weeks.
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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using reliable contraception.
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I do not have any ongoing, uncontrolled bleeding issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years after completion of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years after completion of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MTD of CPI-613 when given in combination with mFOLFIRINOX
Overall Survival
Secondary study objectives
Complete pathologic response rates (CRp)
Median Progression free survival (PFS)
Median Time to progression (TTP)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Standard Dose Cohort: CPI-613 + mFOLFIRINOXExperimental Treatment5 Interventions
Novel drug and mitochondrial inhibitor, CPI-613 in conjunction with standard-of-care FOLFRINOX. Consists of a Standard Dose Cohort and Dose escalation cohort using a standard 3 + 3 design starting at 750 mg/m\^2 given at a rate of 4 ml/min ("dose level (DL) 2"). Participants receiving a dose of 1000mg/m\^2 will be treated over 2 hours. In the absence of any DLT, the next DL will begin enrollment. If 1 DLT occurs, the DL will be expanded by 3 participants. If \<33% of participants experience a DLT, the next DL will be opened and will proceed in similarly. Only 2 DLs are expected to be studied: 750 mg/m\^2 and 1000 mg/m\^2. Participants may be enrolled in this cohort after the accrual goal of the standard cohort is met but prior to the completion of treatment of all patients in the standard dose cohort Participants experiencing a DLT will be allowed to continue on the study at the standard DL of 500 mg or lower.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Folinic acid
2012
Completed Phase 3
~1290
Oxaliplatin
2011
Completed Phase 4
~2890
Irinotecan
2017
Completed Phase 3
~2590
CPI 613
2020
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Jeffrey HardacreLead Sponsor
David BajorLead Sponsor
1 Previous Clinical Trials
53 Total Patients Enrolled
Jeffery Hardacre, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Media Library

5-flurouracil (Chemotherapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03699319 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Standard Dose Cohort: CPI-613 + mFOLFIRINOX
Pancreatic Cancer Clinical Trial 2023: 5-flurouracil Highlights & Side Effects. Trial Name: NCT03699319 — Phase 1 & 2
5-flurouracil (Chemotherapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03699319 — Phase 1 & 2
~7 spots leftby Oct 2025
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