NCT00093041已完成1 期
An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (Zalutumumab) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Genmab
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx or larynx.
- •Primary or recurrent disease for which no curative or established palliative treatments are amenable
- •WHO performance status of 1 or 2.
排除标准
- •Received certain other treatments within 4 weeks prior to administration of study drug
- •Previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis).
- •Skin disease requiring systemic or local corticosteroid therapy.
- •Known brain metastasis or leptomeningeal disease.
- •Signs or symptoms of acute illness.
- •Bacterial, fungal or viral infection.
- •Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, myocardial infarction within one year and stomach, lung, heart, hormonal, nerve or blood diseases.
- •Pregnant or breast-feeding women.
- •Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
- •Simultaneous participation in any other trial involving investigational drugs or having participated in a trial within 4 weeks prior to start of trial treatment.
研究组 & 干预措施
Zalutumumab 0.15 mg/kg
Experimental
干预措施: Zalutumumab (Drug)
Zalutumumab 0.5 mg/kg
Experimental
干预措施: Zalutumumab (Drug)
Zalutumumab 1 mg/kg
Experimental
干预措施: Zalutumumab (Drug)
Zalutumumab 2 mg/kg
Experimental
干预措施: Zalutumumab (Drug)
Zalutumumab 4 mg/kg
Experimental
干预措施: Zalutumumab (Drug)
Zalutumumab 8 mg/kg
Experimental
干预措施: Zalutumumab (Drug)
结局指标
主要结局
Adverse Events
时间窗: From study start (Day 0) until follow-up period (up to Day 77)
Number of participants reporting at least one adverse event.
次要结局
- Overall Response (OR), Classification(8 weeks)
研究者
研究点 (5)
Loading locations...
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