NCT00362830已完成1 期
A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年8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
- 60
- 试验地点
- 2
- 主要终点
- Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.
研究概览
简要总结
The purpose of the study is to test how vinflunine interacts with ixabepilone in the human body.
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
- •ECOG status of 0-1
排除标准
- •Inability to tolerate venous access
- •Brain mets
- •Severe nerve damage
- •ANC <2,000/mm3
- •Platelets <100K
- •Bilirubin >= 1.5 times the IULN
- •ALT/AST >= 2.5 times the IULN
- •Creatinine <50 mL/min
- •Prior treatment with vinflunine and/or ixabepilone
- •Strong use of CYPP450 drugs
研究组 & 干预措施
1
Experimental
干预措施: vinflunine + ixabepilone (Drug)
结局指标
主要结局
Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.
时间窗: upon occurrence
次要结局
- Determine the overall safety profile, efficacy and rate and extent to which ixabepilone and vinflunine are absorbed or otherwise available to the treatment site in the body.(upon occurrence)
研究者
研究点 (2)
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