NCT02925000已完成1 期
A Phase I/IIa, Open Label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy
Taiwan Liposome Company3 个研究点 分布在 2 个国家目标入组 46 人开始时间: 2017年6月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose (MTD) determination
研究概览
简要总结
This is a phase I/IIa, Open label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients with Advanced Malignancy.
详细描述
Protocol No: TLC178A1001
Name of Finished Product: LipoVNB (Liposomal Vinorelbine Tartrate)
Title of Study:
Phase I/IIa, Open label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients with Advanced Malignancy.
Study duration:
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TLC178
Experimental
Liposomal Vinorelbine
干预措施: TLC178 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) determination
时间窗: 4 weeks
To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) ofintravenous LipoVNB given every 4 weeks (Q4W) in patients with advanced malignancies.
次要结局
- Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of vinorelbine[(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of tmax calculated by plasma concentration of vinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of t1/2 calculated by plasma concentration of vinorelbine(from day 1 to day 29)
- Progression free survival (PFS) of patients with advanced malignancies treated with LipoVNB(up to 6 months)
- Pharmacokinetics (PK) parameters of AUC(0 - last) calculated by plasma concentration ofvinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of MRT(0-inf) calculated by plasma concentration of 4-O-deacetylvinorelbine(from day 1 to day 29)
- Dose exposure relationship in patients with advanced malignancies treated with single and multipledoses of LipoVNB(up to 6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03(up to 6 months)
- Incidence of Treatment-Emergent Adverse Events(up to 6 months)
- LipoVNB antitumor activity assessed by response rate(up to 6 months)
- Pharmacokinetics (PK) parameters of AUC(0 - last) calculated by plasma concentration of majormetabolite, 4-O-deacetylvinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of majormetabolite, 4-O-deacetylvinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of Cmax calculated by plasma concentration of vinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of tmax calculated by plasma concentration of major metabolite,4-O-deacetylvinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of t1/2 calculated by plasma concentration of 4-O-deacetylvinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of MRT(0-inf) calculated by plasma concentration of vinorelbine(from day 1 to day 29)
- LipoVNB antitumor activity assessed by duration of response(up to 6 months)
研究者
研究点 (3)
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