*Official Title: Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUC0-∞
研究概览
简要总结
Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.
详细描述
The purpose of this study was to determine the bioequivalence of two formulations of Irinotecan Liposome Injection (70mg/m2) in Chinese patients with Advanced Pancreatic Cancer, under fasting condition. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent for participation in the trial.
- •Advanced pancreatic cancer diagnosed by histopathology and / or cytology.
- •Age ≥ 18 years, men or women. BMI is above
- •ECOG score 0 to
- •Life expectancy ≥ 3 months.
- •Adequate bone marrow function.
- •Adequate hepatic function.
- •Adequate renal function.
- •Patient with reproductive potential must agree to use adequate contraception from the signing of informed consent to at least 6 months after the trial
排除标准
- •Patients who have a severe allergy or a significant history of hypersensitivity or an idiopathic reaction attributed to irinotecan or compounds of similar chemical composition to irinotecan ;
- •Patients who have previously used irinotecan liposomes and experienced treatment failure or serious adverse reactions;
- •Patients with severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine, immune system, skin, musculoskeletal, neurological or psychiatric diseases that occurred within 3 months of the first dose of the study drug, and not suitable for this study as determined by the researchers;
- •Patients who have undergone major surgery within 4 weeks of screening or have a schedule for major surgery during the study period;
- •Patients who have received any radiotherapy or chemotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug, traditional Chinese medicine with anti-tumor indications within 4 weeks of the first dose of the study drug, or small molecule targeted drugs within 2 weeks (or 5 half-lives whichever is longer) of the first dose of the study drug;
- •Patients who currently enrolled in any other clinical study, or received other investigational agents within 4 weeks of the first dose of the study drug；
- •Blood donation or massive blood loss (>400mL) within 90 days of screening;
- •Concomitant use of strong CYP3A4 inhibitors or inducers, or UGT1A1 inhibitors within 4 weeks of the first dose of the study drug;
- •Patients who received certain diet (such as grapefruit) which may interfere with the evaluation of PK results;
- •Patients with extended QT/QTc interval (QTcF>480ms);
- •History of alcohol or drugs abuse;
- •Pregnant or lactating women;
- •Patients with known Hepatitis B Virus (HBV DNA≥104), Hepatitis C Virus (anti-HCV positive, HCV RNA positive), Human immunodeficiency virus antibody (anti-HIV positive), or active Treponema Pallidum viral infection;
- •Patients with homozygous UGT1A1*28 genotype or UGT1A1*6 genotype;
- •Patients who are not suitable for this study as determined by the researchers.
研究组 & 干预措施
T-R
Subjects will receive Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV
干预措施: Irinotecan Liposome Injection combined with 5-FU/LV (Drug)
R-T
Subjects will receive Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV
干预措施: Irinotecan Liposome Injection combined with 5-FU/LV (Drug)
结局指标
主要结局
AUC0-∞
时间窗: 0 -190 hours
The exposure of Total Irinotecan and Free Irinotecan from time (0) to infinity (∞) will be calculated for the test product (CSPC) or the reference product (Ipsen).
t1/2
时间窗: 0 -190 hours
The terminal elimination half-life will be calculated for the test product (CSPC) or the reference product (Ipsen).
Cmax
时间窗: 0 -190 hours
Cmax of Total Irinotecan and Free Irinotecan will be measured for the test product (CSPC) or the reference product (Ipsen).
AUC0-t
时间窗: 0 -190 hours
The exposure of Total Irinotecan and Free Irinotecan from time (0) to the last quantifiable concentration (t) will be measured for the test product (CSPC) or the reference product (Ipsen).
Tmax
时间窗: 0 -190 hours
The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).
λz
时间窗: 0 -190 hours
The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).
次要结局
未报告次要终点