“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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516336-97-00

Acronym

NALPAC

Enrollment

134

Registered

2024-09-11

Start date

2022-02-21

Completion date

Unknown

Last updated

2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA

Brief summary

PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD).

Detailed description

Safety/toxicity and tolerability profile: Adverse events, laboratory safety assessment, physical examination, PFS and sensitivity analysis, Objective tumor response according to RECIST v 1.1, Overall survival, Disease control, Duration of response, Exploratory endpoint: Translational analysis on tumor tissue and blood samples

Interventions

DRUGFluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie

DRUGOnivyde pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion

DRUGLevofolic 50 mg/ml oplossing voor injectie / infusie

DRUGOxaliplatin Accord Healthcare 5 mg/ml concentraat voor oplossing voor infusie

DRUGELVORINE 25 mg/2

DRUG5 mL

DRUGsolution injectable

DRUGELVORINE 50 mg/5 mL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD).	—

Measure

Time frame

—

Secondary

Measure	Time frame
Safety/toxicity and tolerability profile: Adverse events, laboratory safety assessment, physical examination, PFS and sensitivity analysis, Objective tumor response according to RECIST v 1.1, Overall survival, Disease control, Duration of response, Exploratory endpoint: Translational analysis on tumor tissue and blood samples	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026