A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of Lapatinib in Combination With Liposomal Doxorubicin in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Cardiac safety
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 doxorubicin hydrochloride liposome 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 doxorubicin hydrochloride liposome may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of doxorubicin hydrochloride liposome when given together with lapatinib in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the safety, tolerability, and feasibility of pegylated doxorubicin HCl liposome (PLD) when administered with lapatinib, particularly in terms of cardiac safety, in patients with metastatic breast cancer.
- Determine the optimally tolerated regimen (OTR) of PLD when administered with lapatinib in these patients.
Secondary
- Determine the pharmacokinetic profiles of lapatinib and PLD when given in combination at the OTR.
- Describe any preliminary evidence of efficacy of lapatinib and PLD in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Lapatinib Ditosylate and Doxil
干预措施: lapatinib ditosylate (Drug)
Lapatinib Ditosylate and Doxil
干预措施: Doxil (Drug)
结局指标
主要结局
Cardiac safety
时间窗: Throughout treatment and up to 30 days post-treatment
Maximum tolerated dose
时间窗: After the first cycle of therapy
次要结局
- Efficacy(At time of disease progression)
- Pharmacokinetic profiles(After treatment completion for 12 patients treated at the maximum tolerated dose)
研究者
William Gradishar
Principal Investigator
Northwestern University