drugset

drugset / Trial / NCT03986294

Second Line Treatment With Nal-IRI and S1 in Pancreatic Cancer

NCT03986294 ↗

Phase 2 Unknown 122 enrolled Academic Medical Center - University of Amsterdam Isala · collab Maastricht University Medical Center · collab Medical University of Vienna · collab Odense University Hospital · collab UMC Utrecht · collab University Hospital Verona, Italy · collab Vall de Hebron, Barcelona, Spain · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

To determine the optimal second line treatment strategy in patients with metastatic pancreatic cancer who underwent a therapy with gemcitabine.

Timeline

Start: 2019-12-01
Primary completion: 2022-01-01
Completion: 2022-01-01

Publications

Gehrels AM, Pijnappel EN, van Daalen EH, Casalino S, Zechetto C, Quinzii A, Prager GW, de Vos-Geelen J, Macarulla T, Melisi D, Ali M, Wilmink JW. Second-line liposomal irinotecan plus S-1 vs. liposomal irinotecan plus 5-fluorouracil in metastatic pancreatic cancer: The phase I/II randomized NAPAN trial. Eur J Cancer. 2026 May 15;239:116683. doi: 10.1016/j.ejca.2026.116683. Epub 2026 Mar 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan Sucrosofate	Other / unclassified	80 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	400 mg/m2	—
Subject	S-1	Small molecule	—	—
Subject	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Indications