NCT00087061已完成1 期
Oral ST1481 in Adults With Malignant Glioma: A Phase I-II Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of gimatecan in patients with recurrent or progressive primary malignant glioma treated with or without concurrent enzyme-inducing anticonvulsant drugs.
- Determine whether this drug has sufficient activity to warrant further development in these patients. (phase II)
Secondary
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetic behaviors of this drug in these patients.
- Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of this drug in these patients.
- Determine the antitumor activity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 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
研究者
研究点 (2)
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