An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Genmab
- 入组人数
- 286
- 试验地点
- 82
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer
详细描述
This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC.
Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.
Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •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 chemotherapy regimens other than platinum-based chemotherapy
- •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
Zalutumumab in combination with Best Supportive Care
干预措施: Zalutumumab (Drug)
zalutumumab
Zalutumumab in combination with Best Supportive Care
干预措施: Control (Other)
Control
Best Supportive Care
干预措施: Control (Other)
结局指标
主要结局
Overall Survival
时间窗: From randomization until death
A patient's overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial.
次要结局
- Objective Tumor Response(From date of randomization until the date of death from any cause, assessed up to 41 months.)
- Duration of Response(Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.)
- Progression Free Survival (PFS)(From randomization until disease progression or death, assessed up to 41 months.)