EUCTR2006-002472-17-SE进行中（未招募）不适用
An Open-labeled, Randomized, Parallel Group Trial of zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in combination with Best Supportive Care, versus Best Supportive Care, in Patients with Non-Curable Squamous Cell Carcinoma of the Head and Neck who have failed standard platinum-based chemotherapy. - zalutumumab in non-curable patients with SCCH
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Genmab A/S
- 入组人数
- 273
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
- •2) Progressive disease according to RECIST confirmed by an IRC during or within 6 months after failure or intolerance to standard platinum-based chemotherapy
- •3) Measurable disease according to RECIST confirmed by IRC
- •4) WHO PS=2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Three or more prior chemotherapy regimens other than platinum based chemotherapy
- •2) Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
- •3) Received the following treatments within 4 weeks prior to Visit 2:
- •? Cytotoxic or cytostatic anti-cancer chemotherapy
- •? Total tumor resection
研究者
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