An Open-labeled Trial With a Dose-escalation Part and a Parallel Group Design(1) Investigating Zalutumumab, an Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation as First Line Treatment of Patients With Cancer of the Head and Neck (1) The Parallel Group Part Was Cancelled
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Genmab
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with 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
- •Patients with locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
排除标准
- •Prior treatment with radiotherapy in the head and neck area
- •Prior treatment with chemotherapy
- •Prior treatment with similar drugs (e.g. EGFr antibodies, EGFr inhibitors)
- •Previous surgery with curative intent for head and neck cancer
研究组 & 干预措施
Zalutumumab 4 mg/kg
Zalutumumab 8 weekly infusions
干预措施: zalutumumab (Drug)
Zalutumumab 4 mg/kg
Zalutumumab 8 weekly infusions
干预措施: cisplatin (Drug)
Zalutumumab 4 mg/kg
Zalutumumab 8 weekly infusions
干预措施: Radiotherapy (Procedure)
Zalutumumab 8 mg/kg
Zalutumumab 8 weekly infusions
干预措施: zalutumumab (Drug)
Zalutumumab 8 mg/kg
Zalutumumab 8 weekly infusions
干预措施: cisplatin (Drug)
Zalutumumab 8 mg/kg
Zalutumumab 8 weekly infusions
干预措施: Radiotherapy (Procedure)
Zalutumumab 12 mg/kg
Zalutumumab 8 weekly infusions
干预措施: zalutumumab (Drug)
Zalutumumab 12 mg/kg
Zalutumumab 8 weekly infusions
干预措施: cisplatin (Drug)
Zalutumumab 12 mg/kg
Zalutumumab 8 weekly infusions
干预措施: Radiotherapy (Procedure)
Zalutumumab 16 mg/kg
Zalutumumab 8 weekly infusions
干预措施: zalutumumab (Drug)
Zalutumumab 16 mg/kg
Zalutumumab 8 weekly infusions
干预措施: cisplatin (Drug)
Zalutumumab 16 mg/kg
Zalutumumab 8 weekly infusions
干预措施: Radiotherapy (Procedure)
结局指标
主要结局
Adverse Events
时间窗: Overall Study
Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.
次要结局
- Overall Response(Up to 3 years)
- Time to Response(Up to 3 years)
- Best Overall Tumor Response(Up to 3 years)