An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not previously received chemotherapy for metastatic adenocarcinoma of the pancreas

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518303-21-00

Acronym

D-US-60010-001

Enrollment

Registered

2024-10-17

Start date

2020-05-25

Completion date

2025-02-18

Last updated

2024-10-17

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

Conditions

Metastatic Pancreatic Adenocarcinoma

Brief summary

The primary efficacy endpoint is the overall survival of subjects treated with irinotecan liposome injection +oxaliplatin+5 FU/LV compared to subjects treated with nab paclitaxel+gemcitabine.

Detailed description

Progression Free Survival, Overall Response Rate, The secondary efficacy endpoints (PFS and ORR) will only be evaluated if the primary efficacy endpoint demonstrates superiority for irinotecan liposome injection+oxaliplatin+5‑FU/LV over nab-‑ paclitaxel+gemcitabine.

Interventions

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

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

DRUGOxaliplatin Accord 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGFluorouracil Accord 50 mg/ml šķīdums injekcijām vai infūzijām

DRUGCALCIUM FOLINATE

DRUGGEMCITABINE ACCORD 100 mg/ml

DRUGsolution à diluer pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the overall survival of subjects treated with irinotecan liposome injection +oxaliplatin+5 FU/LV compared to subjects treated with nab paclitaxel+gemcitabine.	—

Secondary

Measure	Time frame
Progression Free Survival, Overall Response Rate, The secondary efficacy endpoints (PFS and ORR) will only be evaluated if the primary efficacy endpoint demonstrates superiority for irinotecan liposome injection+oxaliplatin+5‑FU/LV over nab-‑ paclitaxel+gemcitabine.	—

Countries

Spain

Outcome results

None listed

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