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

PHASE2RecruitingINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

May 25, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Metastatic Pancreatic Ductal Adenocarcinoma
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

Trial Locations (13)

1070

RECRUITING

ULB Erasme, Brussels

1200

RECRUITING

Cliniques Universitaires Saint-Luc UCL, Brussels

2300

RECRUITING

AZ Turnhout, Turnhout

2650

RECRUITING

UZ Antwerpen, Antwerp

4000

RECRUITING

CHC MontLégia, Liège

7100

RECRUITING

Pôle Hospitalier Jolimont (HELORA), Haine-Saint-Paul

Unknown

NOT_YET_RECRUITING

AZ St-Lucas, Bruges

RECRUITING

AZ Imelda, Bonheiden

RECRUITING

Grand Hopital de Charleroi, Charleroi

RECRUITING

AZ Maria Middelares, Ghent

RECRUITING

University Hospital Ghent, Ghent

RECRUITING

CHU Ambroise Paré, Mons

RECRUITING

CHR Namur, Namur

All Listed Sponsors
collaborator

University Hospital St Luc, Brussels

OTHER

lead

Belgian Group of Digestive Oncology

OTHER