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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 14
- 主要终点
- To evaluate the bioequivalence of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) & Les Laboratoires Serviers Onivyde (Irinotecan liposome injection) in combination with 5- fluorouracil (5-FU) & leucovorin (LV) in patients with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine.
研究概览
简要总结
A Bioequivalence Study with Mylan’s Irinotecan Liposomal Injection in patient with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine.
Primary Objective: To evaluate the bioequivalence of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) and Les Laboratoires Servier’s 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.
Secondary Objective: To evaluate the safety and tolerability of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) and Les Laboratoires Servier’s 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
- •Patients with documented disease progression after prior gemcitabine or gemcitabine-containing therapy, in locally advanced or metastatic setting
- •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
- •Males and/or non-pregnant, non-lactating females.
排除标准
- •Patients who are known for gene-drug interaction
- •Known hypersensitivity to any of the components of investigational medicinal product, other liposomal products, fluoropyrimidines, or leucovorin.
- •Patients receiving or scheduled to receive strong CYP3A4 inducers
- •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
- •Intolerance to venipuncture.
- •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.
- •Patients with confirmed novel coronavirus infection (COVID-19).
结局指标
主要结局
To evaluate the bioequivalence of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) & Les Laboratoires Serviers Onivyde (Irinotecan liposome injection) in combination with 5- fluorouracil (5-FU) & leucovorin (LV) in patients with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine.
时间窗: Primary analysis will be on the pharmacokinetic parameters derived from the plasma concentration data collected from the samples starting on Day 1 (Day of dosing).
次要结局
- To evaluate the safety & tolerability 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.(Safety will be assessed throughout the study, i.e., from signing of ICF to end of study visit.)