EUCTR2008-007097-38-FR进行中（未招募）1 期
A randomized, open-label Phase II study of BIBW 2992 versus cetuximab (Erbitux®) in patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) after failure of platinum-containing therapy with a cross-over period for progressing patients.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
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
- •Metastatic (stage IV) or recurrent HNSCC
- •Histologically or cytologically confirmed diagnosis of squamous cell carcinomas of the head and the neck.
- •Patients must have documented progressive disease following receipt of prior platinum-based therapy.
- •Patients must have measurable disease as defined by RECIST criteria.
- •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
- •Progressive disease within 3 months after completion of curative intent treatment for localized/locoregionally advanced disease.
- •Prior use of an EGFR or erbB2 inhibitor in the recurrent/metastatic disease setting
- •More than 2 chemotherapeutic regimens given for recurrent/metastatic disease.
- •Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
- •Use of alcohol or drugs incompatible with patient participation in the study in the investigator's opinion.
研究者
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A randomized, open-label Phase II study of BIBW 2992 versus cetuximab (Erbitux®) in patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) after failure of platinum-containing therapy with a cross-over period for progressing patients.EUCTR2008-007097-38-BESCS Boehringer Ingelheim Comm.V146
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