An Open Label, Phase I Study Evaluating Pharmacokinetics, Safety, and Tolerability of ABT-869 in Subjects With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- Safety tolerability assessment
研究概览
简要总结
The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was determined in a previous the M04-710 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days
干预措施: ABT-869 (Drug)
Group 2
Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1
干预措施: ABT-869 (Drug)
Group 3
Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2
干预措施: ABT-869 (Drug)
Group 4
Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3
干预措施: ABT-869 (Drug)
结局指标
主要结局
Safety tolerability assessment
时间窗: Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed
Dose limiting toxicity determination
时间窗: Weekly assessment for the first 3 weeks
Pharmacokinetic profile evaluation
时间窗: Day 1 and Day 15
次要结局
- Preliminary tumor response(Every 6 week)