NCT00513058已完成1 期
Phase I Study Evaluating the Combination of Lapatinib + Vinorelbine in Patients With Locally Advanced or Metastatic Breast Cancer Overexpressing HER2
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 33
- 试验地点
- 5
- 主要终点
- Toxicity as assessed by NCI CTCAE v3.0
研究概览
简要总结
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the tolerability and feasibility of the lapatinib ditosylate and vinorelbine ditartrate combination by determining the maximum tolerated dose of vinorelbine ditartrate in combination with a biologically active dose of lapatinib ditosylate.
Secondary
- Determine the maximum administered dose.
- Investigate the pharmacokinetic interactions related to the combination of vinorelbine ditartrate and lapatinib ditosylate.
- Determine the toxicity of vinorelbine ditartrate and lapatinib ditosylate.
- Determine the objective response rate in patients with measurable lesions.
- Validate the safety and efficacy of the oral vinorelbine ditartrate and lapatinib ditosylate combination, according to the vinorelbine ditartrate oral/IV dose equivalence.
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
- Female
- 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 + vinorelbine
Experimental
- starting with loading dose of lapatinib per os for 7 days
- then, combining lapatinib (oral daily continuous) + vinorelbine (intravenous, day 1 and 8 every 3 weeks)
干预措施: Lapatinib (Drug)
lapatinib + vinorelbine
Experimental
- starting with loading dose of lapatinib per os for 7 days
- then, combining lapatinib (oral daily continuous) + vinorelbine (intravenous, day 1 and 8 every 3 weeks)
干预措施: vinorelbine (Drug)
结局指标
主要结局
Toxicity as assessed by NCI CTCAE v3.0
时间窗: during the first cycle of treatment
次要结局
- Pharmacokinetic interactions between vinorelbine ditartrate (oral or IV) and lapatinib ditosylate(during the first cycle of treatment)
- Tumor response as assessed by RECIST criteria after every 2 courses(during 6 months)
研究者
研究点 (5)
Loading locations...
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