Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05209074
PHASE1

Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

Sponsor: Case Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Official title: A Phase I, Single-Center, Open-Label, Dose De-escalation and Expansion Study Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2022-09-08

Completion Date

2026-12-31

Last Updated

2025-09-05

Healthy Volunteers

No

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.

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States