NCT00359190已完成1 期
A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients With Treatment- Naive Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples.
研究概览
简要总结
This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
Lapatinib receivers
Experimental
Subjects with treatment-naïve breast tumors will be administered lapatinib 1500 mg once daily, 1000 mg once daily, or 500 mg twice daily for a minimum of 9 days and maximum of 15 days prior to surgical resection..
干预措施: lapatinib (Drug)
结局指标
主要结局
Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples.
时间窗: subjects on study up to 15 days
biomarker analysis of tumor biopsies pre/post dose
次要结局
- Evaluation of adverse events and changes in lab values from pre-dose and post-dose. Assessment of safety & tolerability of lapatinib at multiple doses when administered to patients who have not have not been treated for breast tumors.(subjects on study up to 15 days)
研究者
研究点 (1)
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