NCT00516672已完成1 期
A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
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
- 30
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.
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
- 20 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
Arm 1
Experimental
Pazopanib monotherapy or in combination with lapatinib
干预措施: pazopanib (Drug)
Arm 1
Experimental
Pazopanib monotherapy or in combination with lapatinib
干预措施: Lapatinib (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: before and after taking the study medications
The safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), and changes in vital signs and laboratory values.
次要结局
- Pharmacokinetics(over a 24 hour period)
- Tumor response(9 weeks)
研究者
研究点 (1)
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