NCT01245556已完成1 期
A Phase 1 Study of a RAF Inhibitor (BMS-908662) Administered in Combination With Immunotherapy (Ipilimumab) in Subjects With Unresectable Stage III or Stage IV Melanoma
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2011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
- 8
- 试验地点
- 2
- 主要终点
- Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
研究概览
简要总结
The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when administered in combination with ipilimumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
BMS-908662 or Ipilimumab (A)
Experimental
干预措施: BMS-908662 (Drug)
BMS-908662 or Ipilimumab (A)
Experimental
干预措施: Ipilimumab (Drug)
BMS-908662 or Ipilimumab (B)
Experimental
干预措施: BMS-908662 (Drug)
BMS-908662 or Ipilimumab (B)
Experimental
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
时间窗: Assessments approximately every 3 weeks throughout the duration of the trial
次要结局
- Efficacy as determined by estimates of objective response rates and response duration(Efficacy measured every 6 weeks until week 48, then every 12 weeks)
- PK for BMS-908662 as determined by minimum and maximum observed concentrations, time of maximum observed concentration, area under the concentration curve for one dosing interval and the accumulation index(PK measured during first 4 weeks on study)
- PD will be assessed by evaluating markers of RAS/RAF pathway activity(PD assessed during the first 4 weeks on study)
研究者
研究点 (2)
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