NCT01046266已完成1 期
An Exploratory, Open Label Multicenter Study to Investigate Pharmacodynamic of RO5083945, a Human Monoclonal Antibody Antagonist of Epidermal Growth Factor Receptor (EGFR), Compared to Cetuximab in Patients With Operable Head and Neck Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- immune cell infiltration head and neck squamous cell cancer (HNSCC)
研究概览
简要总结
This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is <50.
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
- •adult patients, >/=18 years of age
- •squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
排除标准
- •carcinoma of nasal cavity, paranasal sinus and nasopharynx
- •recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
- •known positivity for HIV, hepatitis B and/or hepatitis C infection
研究组 & 干预措施
A
Experimental
干预措施: RO5083945 (Drug)
B
Active Comparator
干预措施: cetuximab (Drug)
结局指标
主要结局
immune cell infiltration head and neck squamous cell cancer (HNSCC)
时间窗: through study completion or early study discontinuation
次要结局
- safety and efficacy: AEs, laboratory parameters, tumour assessments(through study completion or early study discontinuation)
- pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels(through study completion or early study discontinuation)
研究者
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