NCT00113581已完成1 期
A Phase I Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Three Doses of Humanised EGFR Antibody EMD 72000 in Combination With ECX in Patients With Advanced Oesophagogastric Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
The main purpose of this study is to test the safety and tolerability and effectiveness of a new treatment, EMD 72000 (matuzumab), for advanced oesophagogastric cancer in combination with the chemotherapy regimen ECX (epirubicin, cisplatin and capecitabine).
In addition the study will look at pharmacokinetic (how the the body takes up the drug) and pharmacodynamic parameters (what the drug does in the body).
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
- •Advanced, recurrent or metastatic gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
- •EGFR positive tumor
- •KPS greater than 60
- •Normal cardiac function
- •Adequate liver and bone marrow function
- •GFR greater than 60 ml/minute
排除标准
- •Previous chemotherapy
- •Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrythmias
- •Clinically significant ECG or cardiac history
- •Radiotherapy or surgery within last 4 weeks
结局指标
主要结局
Safety and tolerability
次要结局
- Response rate
- Pharmacodynamic parameters
- Pharmacokinetic parameters
研究者
研究点 (1)
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