NCT00259987已完成2 期
A Phase II, Open-Label Study Evaluating Clinical Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of Lapatinib (GW572016) in Patients With Relapsed Adenocarcinoma of the Esophagus, Including Tumors of the Gastroesophageal Junction and Gastric Cardia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)
研究概览
简要总结
This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Has a histologically confirmed adenocarcinoma of the esophagus.
- •GE (gastroesophageal) junction or gastric cardia.
- •Must be of non-child-bearing potential or is of child-bearing potential.
- •Have a negative serum pregnancy test and agree to an approved form of birth control.
- •Have an ECOG (Eastern Cooperative Oncology Group) Performance status less than or equal to
- •Have a life expectancy of at least 12 weeks.
- •Have provided written informed consent.
- •Investigator considers patient to be fit for study from lab test results and interview.
排除标准
- •Pregnant or lactating female.
- •Prior resection of the small bowel.
- •Received major surgery.
- •Received prior radiation therapy to the mediastinum or abdomen.
- •Has a known immediate or delayed hypersensitivity reaction.
- •Idiosyncrasy to drugs chemically related to the study drug.
结局指标
主要结局
Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)
时间窗: daily throughout the study
次要结局
- Safety and clinical benefit of lapatinib therapy, progression-free survival, and response duration in the two dose levels combined as well as for the two doses separately.(throughout the study)
研究者
研究点 (7)
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