NCT01134640已完成不适用
A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 11
- 主要终点
- Safety and toxicity of Erbitux in clinical practice
研究概览
简要总结
A post marketing surveillance, prospective study to collect safety information from 250 subjects with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type metastatic colorectal cancer treated with Erbitux as final evaluable cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EGFR expressing, KRAS wild-type subjects with metastatic colorectal cancer, who are indicated for Erbitux treatment according to the nationally authorized label (in combination with irinotecan, metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy)
排除标准
- •Subjects who are not eligible for Erbitux treatment according to the indication in national label; or with hypersensitivity reactions (grade 3 or 4) to Erbitux
结局指标
主要结局
Safety and toxicity of Erbitux in clinical practice
时间窗: Till 28 days after last dose of Erbitux
To obtain safety information on the use of Erbitux in subjects with metastatic colorectal cancer.
次要结局
未报告次要终点
研究者
研究点 (11)
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