EUCTR2008-000582-39-AT进行中（未招募）不适用
An Open label single arm trial investifating zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in combination with Best Supportive Care, in Patients with Non-Curable Squamous Cell Carcinoma of the Head and Neck who Failes 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
- 100
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) Patients must have disease progression according to RECIST.
- •3) Measurable disease defined as one or more target lesions according to RECIST.
- •4) WHO performance status = 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 unless given as part of first line treatment of locally or regionally advanced SCCHN in combination with chemotherapy and/or radiotherapy. Exposure to EGFr targeted therapy must be completed = 6 weeks prior to visit 2
- •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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