NCT00437424已完成1 期
A Pharmacokinetic Study of Brivanib (BMS-582664) in Subjects With Advanced Solid Tumor Malignancies and Normal Hepatic Function or Hepatocellular Carcinoma With Impaired Hepatic Function
Bristol-Myers Squibb5 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2007年7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
- 24
- 试验地点
- 5
- 主要终点
- The primary objective of this study is to determine the effect of BMS-582664 on subjects with varying levels of hepatic impairment and guide prescribers with regards to dosing in specialized populations
研究概览
简要总结
The primary purpose of this protocol is to determine the effect of BMS-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment
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
- •Subjects with a biopsy proven advanced solid tumor
- •Subjects with a biopsy proven diagnosis of hepatocellular carcinoma conforming to child pugh classifications A, B, or C
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Brivanib (Drug)
结局指标
主要结局
The primary objective of this study is to determine the effect of BMS-582664 on subjects with varying levels of hepatic impairment and guide prescribers with regards to dosing in specialized populations
时间窗: throughout the study
次要结局
- To assess safety and tolerability of BMS-582664 in subjects with HCC with mild, moderate, and severe hepatic impairment and in subjects with advanced malignancies with normal hepatic function(by Day 1 and Day 28 Pharmacokinetics)
- To assess efficacy of BMS-582664 in subjects with advanced solid tumor malignancies and subjects with HCC by CT or MRI(every 6 weeks until disease progression)
研究者
研究点 (5)
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