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Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

NCT05209074 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-09-05

No results posted yet for this study

Summary

This study is a single-arm, phase I trial, up to 16 participants with resectable PDA. The study will examine the efficacy of the mutant IDH1 inhibitor ivosidenib, in conjunction with standard-of-care mFOLFIRINOX in the neoadjuvant setting.

Conditions

Interventions

DRUG

Ivosidenib

Ivosidenibflat dose (250mgor 500mg) daily on day 1 of a 14 day cycle.

DRUG

mFOLFIRINOX

mFOLFIRINOX on days 1-3 of a 14-day cycle. Surgical resection after up to ninety (90) days of treatment.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • David Bajor, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2026-07-15
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05209074 on ClinicalTrials.gov