Loading clinical trials...

Evaluate Efficacy of Devimistat in Combination With mFFX in 2nd Line Patients With Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Evaluate Efficacy of Devimistat in Combination With mFFX in 2nd Line Patients With Metastatic Pancreatic Cancer

A Phase 2 Single Center Open-Label Trial to Evaluate Efficacy and Safety of Devimistat in Combination With Modified FOLFIRINOX (mFFX) in 2nd Line Patients With Metastatic Adenocarcinoma of the Pancreas

NCT06518538•Cornerstone Pharmaceuticals

View on ClinicalTrials.gov

Summary

Open label, randomized phase II study to evaluate efficacy and safety of CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+13 more criteria

Exclusion Criteria

•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
+5 more criteria

Locations (1)

Hirschfeld Oncology

Brooklyn, New York, United States

Key Dates

Start Date

August 15, 2024

Primary Completion Date

August 1, 2026

Completion Date

November 1, 2026

Last Updated

August 15, 2024

Conditions

Pancreatic Cancer Stage IV

Interventions

CPI-613, modified Folfirinox

DRUG

Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer

NCT05254171

Pancreatic Cancer MetastaticPancreatic Ductal Adenocarcinoma+1 more

View study

UNKNOWN

Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells

NCT04628806

Melanoma Stage IVSarcoma+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions