NCT00017264已完成1 期
A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 20
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of atrasentan in treating patients who have progressive or recurrent malignant glioma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of atrasentan in patients with progressive or recurrent malignant glioma.
- Describe the pharmacokinetics of this drug in these patients.
- Assess preliminary evidence of therapeutic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral atrasentan once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 2-10 patients receive escalating doses of atrasentan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1 patient experiences dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 (20)
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