NCT01598077已完成1 期
A Phase I Study of LJM716 in Patients With Squamous Cell Carcinoma of Head and Neck, or HER2 Overexpressing Metastatic Breast Cancer or Gastric Cancer
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
- 54
- 试验地点
- 5
- 主要终点
- Dose-limiting toxicities (DLTs)
研究概览
简要总结
This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer
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
Dose escalation and dose expansion
Experimental
干预措施: LJM716 (Drug)
结局指标
主要结局
Dose-limiting toxicities (DLTs)
时间窗: 4 weeks
次要结局
- Serious adverse events(4 months)
- Serum concentration of antibodies to LJM716(18 months)
- Serum concentration of LJM716,(4 months)
- Frequency of partial responses, complete responses and stable disease according to RECIST(every 2 months)
- Adverse events(4 months)
- Pharmacodynamic response to LJM716 in tumor tissue(3 months)
- Progression-free survival(18 months)
- Duration of response(18 months)
研究者
研究点 (5)
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