NCT01018745已完成1 期
Phase 1 Multiple Ascending Dose Study of BMS-907351 (XL184) Monotherapy in Japanese Subjects With Advanced or Metastatic Solid Tumors
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
研究概览
简要总结
The purpose of this clinical study is to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- •Life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group performance 0-2
排除标准
- •Subject has uncontrolled intercurrent illness
研究组 & 干预措施
BMS-907351 (XL184)
Experimental
干预措施: BMS-907351 (XL184) (Drug)
结局指标
主要结局
To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
时间窗: Within the first 28 days
次要结局
- To assess the safety and tolerability of multiple doses of BMS-907351 (XL184) administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors(Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter)
- To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors(Day 1, 5, 15, 19 and 29)
- To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184)(Every 8 weeks)
- To assess the pharmacodynamic correlates of BMS-907351 (XL184) activity(Day 1, 5, 15, 19, 29 and every 4 weeks thereafter)
研究者
研究点 (1)
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