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Bioequivalence of Onivyde manufacturing sites in metastatic pancreatic adenocarcinoma
NCT05383352Phase 1Completed
- Sponsor
- Ipsen
- Start
- May 2022
- Primary completion
- May 2024
- Modality
- Small Molecules
- Countries
- 7
01
Overview
Phase 1, randomised, open-label trial of irinotecan liposome injection in pancreatic adenocarcinoma (PDAC) (2 arms), sponsored by Ipsen. Primary endpoints: Maximum plasma concentration of encapsulated irinotecan, Area under the plasma concentration-time curve from time 0 to time t of encapsulated irinotecan and 1 more. Started May 2022; status: completed.
02
Drugs
irinotecan liposome injection
03
Conditions
pancreatic adenocarcinoma (PDAC)
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