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RECRUITING
NCT05472259
PHASE2

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

Sponsor: Belgian Group of Digestive Oncology

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2022-05-25

Completion Date

2027-12-31

Last Updated

2025-02-06

Healthy Volunteers

No

Interventions

DRUG

Nanoliposomal irinotecan

In the control arm (Naliri) a dose of 70mg/m² is administered in combination with 5FU and leucovorin In the investigational arm (Nalirinox) a dose of 50mg/m² is administered in combination with 5FU, leucovorin and oxaliplatin

DRUG

5 FU

In the control arm (Naliri) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan and leucovorin In the investigational arm (Nalirinox) a dose of 2400 mg/m² is administered in combination with nanoliposomal irinotecan, leucovorin and oxaliplatin

DRUG

Leucovorin

In the control arm (Naliri) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan and 5FU In the investigational arm (Nalirinox) a dose of 400 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and oxaliplatin

DRUG

Oxaliplatin

Only administered in the investigational arm (Nalirinox): a dose of 60 mg/m² is administered in combination with nanoliposomal irinotecan, 5FU and Leucovorin

Locations (13)

UZ Antwerpen

Antwerp, Antwerp, Belgium

ULB Erasme

Brussels, Brussels Capital, Belgium

Cliniques Universitaires Saint-Luc UCL

Brussels, Brussels Capital, Belgium

CHC MontLégia

Liège, Liège, Belgium

AZ St-Lucas

Bruges, West-Vlaanderen, Belgium

AZ Imelda

Bonheiden, Belgium

Grand Hopital de Charleroi

Charleroi, Belgium

AZ Maria Middelares

Ghent, Belgium

University Hospital Ghent

Ghent, Belgium

Pôle Hospitalier Jolimont (HELORA)

Haine-Saint-Paul, Belgium

CHU Ambroise Paré

Mons, Belgium

CHR Namur

Namur, Belgium

AZ Turnhout

Turnhout, Belgium