NCT00542308已完成2 期
An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Genmab
- 入组人数
- 90
- 试验地点
- 48
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Males and females age ≥ 18 years
- •Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
- •Failure to at least one course of standard platinum-based chemotherapy
排除标准
- •Three or more prior chemotherapy regimens
- •Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
- •Past or current malignancy other than SCCHN, except for certain other cancer diseases
研究组 & 干预措施
Zalutumumab 4-16 mg/kg
Experimental
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
干预措施: Zalutumumab (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From randomization until death, assessed up to 21 months
OS was defined as time from start of treatment until date of death of any cause.
次要结局
- Progression Free Survival (PFS)(During treatment and two weeks after end of treatment, assessed up to 21 months)
- Objective Tumour Response(During treatment and two weeks after end of treatment, assessed up to 21 months.)
- Duration of Response(During treatment and two weeks after end of treatment, assessed up to 21 months)
研究者
研究点 (48)
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