NCT00606515已完成4 期
A Clinical Trial to Compare the Pharmacokinetics of Two Formulations of Taxane, Paclitaxel Injection and Liposomal Paclitaxel, in Humans
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters
研究概览
简要总结
The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.
详细描述
The pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) has never been studied in Chinese cancer patients. This clinical trial is designed to find out the pharmacokinetics of liposomal paclitaxel at the dose of 175mg/m2 and whether it has a different pharmacokinetic profile to paclitaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients must have histologically confirmed solid tumors of advanced stages
- •Patients who are suitable for being treated with liposomal paclitaxel only
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •Patients who are expected to be alive for at least 3 months
- •Adequate hematologic, hepatic and renal functions
- •Adequate other organ functions as defined by the protocol
- •No prior systemic chemotherapy at least 4 weeks before the recruitment
- •No previous anaphylactic reaction to hormone.
排除标准
- •Allergy to any study medication
- •Serious complication that would compromise the patient's ability to complete the study
- •Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria
- •Pregnancy or breast feeding
研究组 & 干预措施
A
Experimental
Liposomal paclitaxel
干预措施: Liposomal paclitaxel (Drug)
B
Active Comparator
Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Pharmacokinetic parameters
时间窗: 72 hours after the infusion
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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