NCT02136927终止1 期
Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 12
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
Pharmacokinetic, bioequivalence study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject has given written, informed consent and is available for the entire study.
- •Histologically or cytologically confirmed diagnosis of breast cancer;
- •Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
- •Age 18 years or more
排除标准
- •Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
- •Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;
- •Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);
- •Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study
研究组 & 干预措施
SPARC1210
Experimental
Intravenous administration of SPARC1210
干预措施: SPARC1210 (Drug)
Reference1210
Active Comparator
Intravenous administration of Reference1210
干预措施: Reference1210 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Pre-dose, post-dose up to 3 days
Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose.
次要结局
未报告次要终点
研究者
研究点 (12)
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