NCT00332748终止1 期
Effect of Esomeprazole on the Pharmacokinetics of BMS-275183 in Patients With Advanced Malignancies
Bristol-Myers Squibb4 个研究点 分布在 2 个国家目标入组 36 人开始时间: 2006年12月最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- To assess the safety of taking Nexium in combination with oral taxane and the effect this combination has on oral taxane's exposure levels in the body.
研究概览
简要总结
The purpose of this study is to determine what effects Esomeprazole (Nexium) has on increasing or decreasing the amount of oral taxane in the blood, and to determine the safety of oral taxane and effect of oral taxane on the cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Advanced cancers excluding cancers within the blood
- •Adequate kidney and liver function
- •> = 4 weeks from last course of chemotherapy
排除标准
- •Inability to swallow capsules
- •Other active medical disorder
- •Abnormal heart function or use of drugs that affect the heart
结局指标
主要结局
To assess the safety of taking Nexium in combination with oral taxane and the effect this combination has on oral taxane's exposure levels in the body.
次要结局
- To assess the safety of a single dose of oral taxane followed by a therapeutic regimen of oral taxane administered twice weekly
研究者
研究点 (4)
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