RecruitingPhase 2NCT05472259

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

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

Sponsor

Belgian Group of Digestive Oncology

Enrollment

134 participants

Start Date

May 25, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 5 FU, a drug called Leucovorin, and others for people with metastatic pancreatic ductal adenocarcinoma. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNanoliposomal 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

DRUG5 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

DRUGLeucovorin

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

DRUGOxaliplatin

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

View Full Details on ClinicalTrials.gov

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NCT05472259

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