NCT00243087已完成1 期
An Open Phase I Single Dose Escalation Study of BI 2536 Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 8
- 主要终点
- Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course
研究概览
简要总结
RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating patients with refractory or relapsed advanced non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of BI 2536 in patients with refractory or relapsed advanced aggressive non-Hodgkin's lymphoma.
- Determine the safety and tolerability of this drug in these patients.
Secondary
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine, preliminarily, 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 120 Years（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
Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course
时间窗: up to 22 days of each course
Dose-limiting toxicity as measured by CTCAE v3.0 at days 1-22 of each course
时间窗: up to 22 days of each course
次要结局
- Objective tumor response by CT scan or MRI as measured by RECIST criteria on day 22 of each even numbered course(day 22 of every second course)
- Pharmacokinetics as measured in blood samples at days 1, 2, 3, and 8 during first course and on day 1 of each subsequent course(day 22 of each course)
研究者
研究点 (8)
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