Spots Global Cancer Trial Database for A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
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Trial Identification
Brief Title: A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)
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
Study ID: NCT05472259
Study Description
Brief 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
Detailed 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)
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
AZ St-Lucas, Brugge, West-Vlaanderen, Belgium
UZ Antwerpen, Antwerp, , Belgium
AZ Imelda, Bonheiden, , Belgium
ULB Erasme, Brussels, , Belgium
Cliniques Universitaires Saint-Luc UCL, Brussels, , Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
AZ Maria Middelares, Ghent, , Belgium
University Hospital Ghent, Ghent, , Belgium
CHC MontLégia, Liège, , Belgium
AZ Sint-Maarten, Mechelen, , Belgium
CHU Ambroise Paré, Mons, , Belgium
CHR Namur, Namur, , Belgium
Contact Details
Name: Ivan Borbath
Affiliation: University hospital St-luc, Brussel
Role: PRINCIPAL_INVESTIGATOR
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