An open-label, randomized, multi-center, three-period, three-treatment, three-sequence, single-dose, crossover, pharmacokinetic study of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) and Les Laboratoires Serviers Onivyde (Irinotecan liposome injection) in combination with 5- fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine - NI

Mylan Laboratories Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1. Patient with Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
•2. Patients with documented disease progression after prior gemcitabine or gemcitabine-containing therapy, in locally advanced or metastatic setting
•3. Patients of 18-75 years of age, must meet age requirements at the time of signing the initial informed consent and the initial study medication administration
•4. Males and/or non-pregnant, non-lactating females.

•1. Patients who are known for gene-drug interaction
•2. Known hypersensitivity to any of the components of investigational medicinal product, other liposomal products, fluoropyrimidines, or leucovorin.
•3. Patients receiving or scheduled to receive strong CYP3A4 inducers
•4. Any other medical or social condition deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
•5. Intolerance to venipuncture.
•6. Donation or loss of blood or plasma: greater than or equal to 350 mL or more within 90 days prior to the initial dose of the study medication.
•7. Patients with confirmed novel coronavirus infection (COVID-19).

发起方