NCT00369395终止2 期
A Phase 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 19
- 试验地点
- 7
- 主要终点
- Progression Free Survival (PFS) rate at the Week 8 visit, defined as the number of subjects who have not progressed by the Week 8 visit
研究概览
简要总结
This is a Phase 2, multicenter, research study determining the effects of an investigational drug called volociximab in metastatic melanoma.
The purpose of the study is to compare the clinical benefit and safety of volociximab. Pharmacokinetics and mechanism of action will also be evaluated.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Volociximab
Experimental
Volociximab 15 mg/kg
干预措施: volociximab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) rate at the Week 8 visit, defined as the number of subjects who have not progressed by the Week 8 visit
时间窗: 8 weeks intervals
次要结局
- Pharmacokinetics of volociximab(Every infusion and follow up visit)
- Assess safety by recording and evaluating adverse events (AEs); changes in vital signs, hematology, blood chemistry, and urinalysis parameters; and anti-volociximab antibody formation(Throught study and follow up period,approx. 15 months)
研究者
研究点 (7)
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