Investigation of Mass Balance and Major Metabolites After Administration of 28 mg Radiolabeled ZK 219477 in Patients With Solid Tumor in an Open-label, Non Randomized Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 7
- 主要终点
- AUC(0-24)
研究概览
简要总结
The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male ≥ 18 years; female ≥ 50 years without childbearing potential (confirmed by either: age ≥ 60; or history of hysterectomy; or hormone analysis in serum: Estradiol ≤ 20 pg/mL and follicle stimulating hormone ≥ 40 IU/L)
- •Solid tumor
- •Adequate function of major organs
- •Failed previous cancer treatment
- •Peripheral venous access
排除标准
- •Concurrent severe and/or uncontrolled disease
- •Brain tumors
- •Marked constipation
研究组 & 干预措施
Sagopilone
Subjects received 28 mg ZK 219477, containing 14 kBq/7.8 µg [14C]-ZK 219477 in the first infusion (Treatment course 1) followed by subsequent infusions (Treatment courses 2 to n [till disease progression]) of 16 mg/m2 ZK 219477 without radioactive label. Interval between the treatments was at least 21 days.
干预措施: Sagopilone (BAY 86-5302, ZK 219477) (Drug)
结局指标
主要结局
AUC(0-24)
时间窗: 14 days
AUC from time zero to 24 hours for \[14C\]-ZK 219477, ZK 219477
AUC(0-tlast)
时间窗: 14 days
AUC from administration until the last time point with measurable concentration for \[14C\]-ZK 219477, ZK 219477
Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477.
时间窗: 14 days
Cmax
时间窗: 14 days
Maximum plasma concentration for \[14C\]-ZK 219477, ZK 219477
tmax
时间窗: 14 days
Time to Cmax for \[14C\]-ZK 219477, ZK 219477
AUC
时间窗: 14 days
Area under the concentration time curve for \[14C\]-ZK 219477, ZK 219477
MRT
时间窗: 14 days
Mean residence time for \[14C\]-ZK 219477, ZK 219477
t1/2
时间窗: 14 days
Terminal half-life for \[14C\]-ZK 219477, ZK 219477
λz
时间窗: 14 days
Apparent terminal rate constant for \[14C\]-ZK 219477, ZK 219477
CL
时间窗: 14 days
Total clearance for ZK 219477
Vss
时间窗: 14 days
Apparent volume of distribution at steady state for ZK 219477
Vz
时间窗: 14 days
Apparent volume of distribution during terminal phase for ZK 219477
次要结局
- Number of participants with adverse events(Approximately 12 weeks to 30 weeks)
- Overall response(Approximately 10 to 32 weeks)
- Best overall response(Approximately 10 to 32 weeks)
- Responders(Approximately 10 to 32 weeks)