A Phase Ib Study to Evaluate Tolerability, Safety and Pharmacokinetics of Irinotecan Hydrochloride Liposome Injection in Combination With 5-FU/LV in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Adverse Event (AE)
研究概览
简要总结
This is a dose-escalation and expansion, open label, single centre, phase Ib study. In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection in combination with 5-FU/LV were studied in patients with advanced solid tumors. Meanwhile, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease;
- •Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy;
- •Adequate organ and bone marrow function;
- •sign an informed consent.
排除标准
- •Patients with brain malignant tumor or active CNS metastasis;
- •UGT1A1*28 homozygous mutants;
- •Clinically significant GI disorders;
- •Significant cardiovascular disease;
- •Active infection or uncontrolled fever;
- •Pregnant or breast feeding patients;
- •Allergic to a drug ingredient or component;
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial.
研究组 & 干预措施
Treatment group:
Irinotecan liposome plus 5-fluorouracil, Leucovorin
干预措施: Irinotecan liposome、5-fluorouracil、Leucovorin (Drug)
结局指标
主要结局
Adverse Event (AE)
时间窗: Assessed from study inclusion to 30 days after last dose
Assessed by CTCAE v4.03
Dose Limiting Toxicities (DLT)
时间窗: DLTs will be evaluated during 28-day period following the first dose of study treatment
Dose Limiting Toxicities for patients in combination treatment
Maximal tolerated dose (MTD)
时间窗: after the last patient in each cohort up to 12 months
Maximum tolerated dose for patients in combination treatment
次要结局
- Progression Free Survival(The maximum time in follow up was 12 months)
- Time to reach maximum plasma concentration (Tmax)(up to 168 hours after the first dose)
- Maximum observed plasma concentration (Cmax)(up to 168 hours after the first dose)
- Objective Response Rate(maximum time on study 12 months)
- Area under the plasma concentration versus time curve from time zero to time of last observed concentration (AUC0-t)(up to 168 hours after the first dose)
- Area under the plasma concentration versus time curve from time zero to infinity (AUC0-inf)(up to 168 hours after the first dose)
- Elimination half-life (T1/2)(up to 168 hours after the first dose)
- Clearance of drug from plasma (CL)(up to 168 hours after the first dose)
- Volume of distribution (Vss)(up to 168 hours after the first dose)