NCT05209074

Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Currently, the standard of care treatment for resectable PDA is surgical resection followed by adjuvant chemotherapy. The use of mFOLFIRINOX in this setting has extended survival significantly. Giving ivosidenibwith mFOLFIRINOXmay work better than treating participants with mFOLFIRINOX alone.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Resectable Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-08
• Primary completion: 2026-07-15
• Completion: 2026-12-31
• First posted: 2022-01-26
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study