Evaluate Efficacy Of Devimistat In Combination With MFFX In 2nd Line Patients With Metastatic Pancreatic Cancer

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-07-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-08-14
First Submitted that Met QC Criteria 2024-07-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-08-15
First Posted (ACTUAL) 2024-07-24	Results First Posted N/A	Last Verified 2024-08

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CPI-613+mFFX Day 1: Devimistat at 500 mg/m2 IV infusion over 2 hours mFFX (given immediately after devimistat administration): * Oxaliplatin at 60 mg/m2 given as a 2-hr IV infusion * Folinic acid at 400 mg/m2 given as 30- 90 min infusion immediately after oxaliplatin	DRUG: CPI-613, modified Folfirinox * CPI-613, devimistat * mFFX: Oxaliplatin, Folinic acid, Fluorouracil and Irinotecan

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CPI-613+mFFX

Day 1: Devimistat at 500 mg/m2 IV infusion over 2 hours mFFX (given immediately after devimistat administration): * Oxaliplatin at 60 mg/m2 given as a 2-hr IV infusion * Folinic acid at 400 mg/m2 given as 30- 90 min infusion immediately after oxaliplatin

DRUG: CPI-613, modified Folfirinox

* CPI-613, devimistat * mFFX: Oxaliplatin, Folinic acid, Fluorouracil and Irinotecan

Primary Outcome Measures	Measure Description	Time Frame
Overall Response Rate (ORR) [Time Frame: At least 2 months (minimum of 4 cycles)] Defined as the rate of Complete Response (CR) plus Partial Response (PR)		12 months

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival (OS) Defined as the duration from the date of randomization to the date of death from any cause		24 months
Progression Free Survival (PFS) Defined as the duration from the date of randomization to the date of progressive defined as the duration from the date of randomization to the date of progressive disease or death from any cause.		12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed metastatic stage IV adenocarcinoma of the pancreas
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
Male and female patients 18 - 75 years of age
Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
Recurrrence or progression while on FFX therapy.
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must agree to use acceptable highly effective contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive(s), intrauterine hormone releasing system (IUS), bilateral tubal occlusion or vasectomized partner) during and for 6 months after last study dose and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
Males with female partners (of childbearing potential) and female partners (of childbearing potential) with male partners must agree to use double barrier contraceptive measure (a combination of male condom with either cap, diaphragm or sponge with spermicide) in addition to oral contraception, or avoidance of intercourse during the study and for 6 months after last study dose is received
At least 4 weeks from major surgery with resolution of any sequela to date of enrollment
Laboratory values ≤2 weeks during screening must be:
Adequate hematologic values

Platelet count ≥100,000 cells/mm3 or ≥100 bil/L;
Absolute neutrophil count [ANC] ≥1,500 cells/mm3 or ≥1.5 bil/L;
Hemoglobin >9 g/dL or >90 g/L
Adequate hepatic function

Aspartate aminotransferase [AST/SGOT] ≤3x upper normal limit [UNL] (≤5xUNL if liver metastasis present)
Alanine aminotransferase [ALT/SGPT] ≤3x UNL (≤5x UNL if liver metastasis present)
Bilirubin (≤1.5x UNL); bilirubin ≤ 2.5 x ULN for subjects with Gilbert's syndrome
Adequate renal function

Serum creatinine clearance CLcr > 30 mL/min). (Cockcroft-Gault Formula should be used for CrCl calculation)
Adequate coagulation function

International Normalized Ratio or INR must be <1.5 unless on anticoagulants
No evidence of active infection and no serious infection within the past 30 days. Patient must have completed antibiotic course.
Mentally competent, ability to understand and willingness to sign the informed consent form and follow protocol requirements

Endocrine or acinar pancreatic carcinoma
Known cerebral metastasis, central nervous system (CNS), or epidural tumor
Patients with hypersensitivity to devimistat, FFX treatment or any of their excipients
Patients receiving any other investigational systemic agent for any indication within the past 2 weeks prior to initiation of devimistat treatment
Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., Hemophilia A)
Female patients who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of study treatment
Female patients of childbearing potential with a positive pregnancy test assessed by a serum pregnancy test at screening
Male patients unwilling to abstain from donating sperm during treatment and for 6 months after completion of study treatment
Active heart disease including but not limited to symptomatic congestive heart failure (NYHA class 3 or 4), 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
Prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, in situ cancer, localized prostate cancer (Gleason score <8), or adequately treated cancer from which the patient has been disease-free for at least 3 years prior to screening
Unwilling or unable to avoid the concomitant use of strong CYP3A4 inducers or inhibitors during treatment with irinotecan (Listed in the APPENDIX II: CYP3A4 Inducers or Inhibitors)
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 470 milliseconds (ms) (CTCAE grade 1) using Fridericia's QT correction formula (i.e. QTcF)
A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
The use of concomitant medications except anti-emetics that prolong the QT/QTc intervals.

Collaborators and Investigators

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