Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 24
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.
详细描述
The purpose of this study is to evaluate level of test medication with respect to time in the body, and safety when compared with the reference medication Subject will be randomly assigned to receive an intravenous infusion of either SPARC1613 delivered over 25 (±1) minutes or Reference1613 delivered over 30 (±1) minutes
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has given written, informed consent and is available for the duration of study
- •Histologically or cytologically confirmed diagnosis of breast cancer
- •Male or female aged ≥ 18 years
- •Females subjects of child-bearing potential must have a negative urine pregnancy test
- •Female subjects must be non-lactating and non-breastfeeding
- •Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing
排除标准
- •Known hypersensitivity to either of the study drugs or their excipients
- •Inability to undergo venipuncture and/or tolerate venous access
- •Pre-existing clinically significant peripheral neuropathy
- •Positive laboratory exclusion test (HIV, HBsAg, or HCV)
- •Treatment with investigational agents or participation in clinical trial within 30 days of study entry
研究组 & 干预措施
SPARC1613
Intravenous administration of SPARC1613
干预措施: Reference1613 (Drug)
Reference 1613
Intravenous administration of Reference1613
干预措施: SPARC1613 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Pre-dose,post dose upto 3 days
次要结局
未报告次要终点