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A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC) — NALPAC  

Metastatic Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:
A Non-comparative Randomized Phase 2 Study, Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Progressive After Gemcitabine-Abraxane or Gemcitabine Monotherapy

Clinical Trial Summary

A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy

Clinical Trial Description

Based on the results of previous studies, the sponsor aims to assess efficacy and safety of this triplet (irinotecan, 5FU/LV and oxaliplatin) in second-line treatment in fit patients (ECOG 0-1) metastatic PDAC. The primary objective is to assess the efficacy of NALIRINOX (= investigational arm) and NALIRI (= standard care arm) in terms of Progression-Free Survival Rate (PFSR). As secondary objectives, the following will be evaluated in both arms: - Safety/toxicity and tolerability profile according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5. - Progression free survival (PFS) - Overall response rate and duration of response as assessed by imaging (RECIST 1.1) and tumor markers - Overall survival (OS) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05472259
Study type Interventional
Source Belgian Group of Digestive Oncology
Contact Lina Dewever
Phone +32 (0) 479 36 63 82
Email lina.dewever@bgdo.org
Status Recruiting
Phase Phase 2
Start date May 25, 2022
Completion date December 31, 2027
View Details
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