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
- 试验地点
- 12
- 主要终点
- Pharmacokinetic (PK) profiles of PICN and Abraxane
研究概览
简要总结
This is a bioavailability study. In this study, PICN and Abraxane® will be administered to enrolled subjects in either period 1 (cycle 1) or period 2 (cycle 2). In cycle 1, subjects will be randomized to receive an intravenous (IV) infusion of either PICN or Abraxane®, over 30 minutes, according to the randomization schedule generated using SAS® software or by using www.randomization.com. Treatment in cycle 2 will be crossed over. During each of cycle, PK samples will be collected. End of study visit will be conducted on Day 22 of cycle 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
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;.
结局指标
主要结局
Pharmacokinetic (PK) profiles of PICN and Abraxane
时间窗: Pharmacokinetic (PK) samples will be collected on Day 1 & 2 of Cycle 1 & 2
次要结局
- Safety of PICN and Abraxane(Safety information will be collected during subject visits on Day 1, 8, 15 of Cycle 1 & 2 and end-of-study.)
研究者
研究点 (12)
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