NCT00316407已完成1 期
Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Toxicity
研究概览
简要总结
The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.
详细描述
The MTD was found in the phase I portion of this study to be oral lapatinib 1000 mg per day for each 4 week cycle and paclitaxel 60 mg/m2 weekly x 3 of a 4 week cycle and carboplatin AUC 2 weekly x 3 of a 4 week cycle.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients.
- •Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease.
- •Ability to swallow and retain oral medications.
- •Measurable disease
排除标准
- •Treatment with previous weekly carboplatin and paclitaxel.
- •No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab.
- •No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.
结局指标
主要结局
Toxicity
时间窗: 1 year
次要结局
- Objective response (PR or CR)(1 year)
研究者
研究点 (4)
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