CTRI/2016/12/007565已完成未知
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).
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 142
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. The subject has given written, informed consent (or legally acceptable representative /impartial
- •witness when applicable) and is available for the duration of study
- •2. Histologically or cytologically confirmed diagnosis of breast cancer
- •3. Estimated life expectancy of at least 12 weeks
- •4. ECOG performance status less than 1
排除标准
- •1. Known hypersensitivity to either of the study drugs or their excipients
- •2. Inability to undergo venipuncture and/or tolerate venous access
- •3. Presence of clinically symptomatic active CNS metastases, including leptomeningial
- •involvement, requiring steroid or radiation therapy
- •4. Pre-existing clinically significant peripheral neuropathy
研究者
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