NCT00281541已完成2 期
A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 9
- 主要终点
- Tumor response rate
研究概览
简要总结
A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.
详细描述
A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma
- •Life expectancy >12 weeks
排除标准
- •History of other malignancy in the last 5 years
- •Major surgery within the past 21 days
结局指标
主要结局
Tumor response rate
时间窗: 6 cycles
次要结局
- Duration of response(6 cycles)
研究者
研究点 (9)
Loading locations...
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