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Clinical trial

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

NCT05383352 is registered in ClinicalTrials.gov with Ipsen as lead sponsor.

NCT NCT05383352
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Ipsen
Phase
Phase 1
Overall status
Completed
Start date
May 30, 2022
Completion date
April 15, 2025
Enrollment
177 (actual)
Sites
36

Conditions

As the registry lists them; a condition with its own page is linked.

metastatic pancreatic adenocarcinoma