CTRI/2014/04/004528Other1 期
A Randomized, Open Label, Two Period, Single Dose, Two Way Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) and Abraxane® in Patients with Locally Recurrent or Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- Other
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •The subject has given written informed consent.
- •-Histologically or cytologically confirmed diagnosis of breast cancer;
- •-Locally recurrent or metastatic breast cancer; Age 18 to 65 years, inclusive;
- •-ECOG Performance Status less than or eual to 1;
排除标准
- •-Known hypersensitivity to both the study drugs or their excipients;
- •-Presence of clinically symptomatic active CNS metastases;
- •-Pre-existing clinically significant peripheral neuropathy;
- •-Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study;
研究者
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