NCT00099060已完成1 期
A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 12
- 主要终点
- Toxicity for phase I assessed by CTCAE v.3.0 MacDonald criteria
研究概览
简要总结
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of lapatinib and to see how well it works in treating patients with recurrent glioblastoma multiforme.
详细描述
OBJECTIVES:
Phase I
- Determine the maximum tolerated dose and recommended phase II dose of lapatinib in patients with recurrent malignant glioblastoma multiforme who are taking CYP3A4 enzyme-inducing anti-epileptic drugs (EIAEDs).
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
Phase II
- Determine the efficacy of this drug, in terms of objective tumor response rate, in patients who are taking EIAEDs and in those who are not taking EIAEDs.
- Correlate immunohistochemical measures of cellular proteins and receptors from tumor samples with anti-tumor activity of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Toxicity for phase I assessed by CTCAE v.3.0 MacDonald criteria
时间窗: 7 years
Response for phase II
时间窗: 7 years
次要结局
- Correlative studies on archival tissue(7 years)
- Pharmacokinetics(7 years)
研究者
研究点 (12)
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