An Open-Label Phase I Study of Fixed Dose Lapatinib in Combination With an Escalating Dose of Epirubicin in Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Optimally-tolerated regimen of lapatinib ditosylate in combination with epirubicin hydrochloride
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 epirubicin, 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 epirubicin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of epirubicin when given together with lapatinib in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To assess the safety and tolerability of fixed-dose lapatinib ditosylate in combination with epirubicin hydrochloride in patients with metastatic breast cancer.
- To determine the optimally-tolerated regimen in these patients.
Secondary
- To determine the clinical efficacy of this regimen in these patients.
- To analyze pharmacokinetic data of this regimen.
- To determine biomarkers that correlate with clinical benefit or response to lapatinib ditosylate 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 120 Years（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 and Epirubicin
Fixed dose of lapatinib in combination with escalating dose of epirubicin.
干预措施: epirubicin hydrochloride (Drug)
Lapatinib and Epirubicin
Fixed dose of lapatinib in combination with escalating dose of epirubicin.
干预措施: lapatinib ditosylate (Drug)
Lapatinib and Epirubicin
Fixed dose of lapatinib in combination with escalating dose of epirubicin.
干预措施: biomarker analysis (Other)
Lapatinib and Epirubicin
Fixed dose of lapatinib in combination with escalating dose of epirubicin.
干预措施: immunohistochemistry staining method (Other)
Lapatinib and Epirubicin
Fixed dose of lapatinib in combination with escalating dose of epirubicin.
干预措施: liquid chromatography (Other)
Lapatinib and Epirubicin
Fixed dose of lapatinib in combination with escalating dose of epirubicin.
干预措施: mass spectrometry (Other)
结局指标
主要结局
Optimally-tolerated regimen of lapatinib ditosylate in combination with epirubicin hydrochloride
时间窗: 2012
次要结局
- Pharmacokinetics(2012)
- Efficacy of this regimen in terms of objective tumor response rate and disease progression as assessed by standard RECIST criteria(2012)
- Correlation between baseline expression of intra-tumoral biomarkers (e.g., ErbB1, ErbB2, insulin-like growth factor-1 receptor, p-AKT, and ERK) and clinical response or benefit to lapatinib ditosylate by IHC(2012)
- Correlation between expression pattern of drug resistance proteins (e.g., p-glycoprotein, MRP1, BCRP, and MDR-3) and clinical response or benefit to lapatinib ditosylate by IHC(2012)