CTRI/2016/12/007565已完成不适用
A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of PaclitaxelInjection Concentrate for Nano-dispersion (PICN) and Abraxane® in Subjects with Locally Recurrent orMetastatic Breast Cancer (MBC).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 24
- 主要终点
- Pharmacokinetic parameter Cmax, and AUC
研究概览
简要总结
This was a multicenter, open-label, randomized, two-period, two treatment, single dose, crossover
bioequivalence study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 91.00 Year(s)（—）
- 性别
- All
入选标准
- •The subject has given written, informed consent (or legally acceptable representative /impartial witness when applicable) and is available for the duration of study
- •Histologically or cytologically confirmed diagnosis of breast cancer
- •Estimated life expectancy of at least 12 weeks
- •ECOG performance status less than 1.
排除标准
- •Known hypersensitivity to either of the study drugs or their excipients
- •Inability to undergo venipuncture and/or tolerate venous access
- •Presence of clinically symptomatic active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy
- •Pre-existing clinically significant peripheral neuropathy.
结局指标
主要结局
Pharmacokinetic parameter Cmax, and AUC
时间窗: Pharmacokinetic parameter Cmax, and AUC
次要结局
未报告次要终点
研究者
研究点 (24)
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