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Clinical trial to evaluate the bioequivalence of Onivyde (irinotecan liposomal injection) manufactured at two different centers and administered in combination with antineoplastics in adult participants with metastatic pancreatic adenocarcinoma.
THE PURPOSE OF THIS CLINICAL TRIAL IS TO COMPARE HOW THE SAME STUDY DRUG, ONIVYDE, IS PROCESSED BY THE BODY WHEN MANUFACTURED AT TWO DIFFERENT PRODUCTION SITES, CAMBRIDGE, MASSACHUSETTS (USA) AND SIGNES (FRANCE). THE REFERENCE ONIVYDE (MANUFACTURED AT IPSEN CAMBRIDGE, USA) WILL BE COMPARED TO THE TEST ONIVYDE (MANUFACTURED AT IPSEN SIGNES, FRANCE).
Technical Summary
- PHASE I, RANDOMIZED, UNBLINDED, SINGLE-DOSE, TWO-STAGE, TWO-WAY CROSSOVER, RANDOMIZED, UNBLINDED, SINGLE-DOSE, TWO-STAGE, BI-THERAPY STUDY TO EVALUATE THE BIOEQUIVALENCE OF ONIVYDE (IRINOTECAN LIPOSOMAL INJECTION) MANUFACTURED AT TWO DIFFERENT CENTERS AND ADMINISTERED IN COMBINATION WITH ANTINEOPLASTICS IN ADULT PARTICIPANTS WITH METASTATIC PANCREATIC ADENOCARCINOMA.
- Code EudraCT: 2021-003264-26
- Protocol number: D-FR-60010-015
- Promoter: IPSEN
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