Trial Profile

A Phase I, Randomised, Open-Label, Single-Dose, Two-Treatment, Two-Way Crossover, Two-Stage Study to Evaluate the Bioequivalence of Onivyde (Irinotecan Liposome Injection) Manufactured at Two Different Sites Administered in Combination With Anti-Cancer Agents in Adult Participants With Metastatic Pancreatic Adenocarcinoma

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 08 May 2025

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At a glance

Drugs Fluorouracil (Primary) ; Folinic acid (Primary) ; Irinotecan (Primary)
Indications Adenocarcinoma; Pancreatic cancer
Focus Pharmacokinetics
Acronyms SIRACUSA
Sponsors Ipsen

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