A Phase I Study of AT7519M Given Twice Weekly in Patients With Advanced Incurable Malignancy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose as assessed by NCI CTCAE v.30
研究概览
简要总结
RATIONALE: AT7519M 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 AT7519M in treating patients with advanced or metastatic solid tumors or refractory non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the recommended phase II dose of AT7519M in patients with advanced or metastatic solid tumors or refractory non-Hodgkin's lymphoma.
- Determine the safety, tolerability, toxicity profile, and dose-limiting toxicities of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Correlate the toxicity profile with pharmacokinetics of this drug in these patients.
Secondary
- Assess, preliminarily, the antitumor activity 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
研究组 & 干预措施
CDKI AT7519
AT7519M (1 hour IV) on days 1, 4, 8 and 11 every 5 weeks.
干预措施: CDKI AT7519 (Drug)
CDKI AT7519
AT7519M (1 hour IV) on days 1, 4, 8 and 11 every 5 weeks.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Maximum tolerated dose as assessed by NCI CTCAE v.30
时间窗: from time of 1st dose
Safety, tolerability, toxicity profile, and dose-limiting toxicities as assessed by NCI CTCAE v.30
时间窗: from time of 1st dose
Pharmacokinetic profile as measured on days 1, 2, and 4 in course 1
时间窗: one month
during cycle 1
Correlation of toxicity profile with pharmacokinetics
时间窗: after completion of each dose level
次要结局
- Preliminary antitumor activity of treatment in patients with measurable disease(Every 60 days)
- Response duration (median and range)(after progression)
- Overall response (complete and partial response) rate(Every 60 days)