NCT00289640已完成2 期
A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Bristol-Myers Squibb26 个研究点 分布在 2 个国家目标入组 210 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 26
- 主要终点
- estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.
研究概览
简要总结
The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: ipilimumab (MDX-010, BMS-734016) (Drug)
2
Experimental
干预措施: Ipilimumab (Drug)
3
Experimental
干预措施: Ipilimumab (Drug)
结局指标
主要结局
estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.
次要结局
- estimate progression free survival rate at Week 12 assessment and other timepoints
- estimate disease control rate at various time points
- estimate overall survival
- estimate survival rate at one year
- evaluate health-related quality of life
- obtain pharmacokinetic samples for population PK analysis
研究者
研究点 (26)
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