NCT00634504已完成1 期
An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 25
- 主要终点
- Pharmacokinetics (PK) of Leucovorin
研究概览
简要总结
The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination
- •Require intravenous leucovorin
排除标准
- •Arm A only: allergic reactions to lactose
- •Arm A only: hereditary fructose or galactose intolerance
- •Arm B only: delayed elimination of MTX
研究组 & 干预措施
A
Experimental
High-dose methotrexate, leucovorin, and Voraxaze
干预措施: glucarpidase, high-dose methotrexate, leucovorin (Drug)
B
Active Comparator
High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)
干预措施: high-dose methotrexate, leucovorin (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of Leucovorin
时间窗: 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration
Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point.
次要结局
未报告次要终点
研究者
研究点 (25)
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