NCT03483038

A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Liposomal Irinotecan in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI Study)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Liposomal Irinotecan	Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle.
DRUG	FOLFOX regimen	Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.

Timeline

• Start date: 2018-12-13
• Primary completion: 2023-09-16
• Completion: 2026-12-01
• First posted: 2018-03-29
• Last updated: 2026-02-27
• Results posted: 2024-09-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study