NL-OMON34195撤回不适用
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. - BP22350
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed Informed consent
- •2. Age >=18 years
- •3. Able and willing to comply with the protocol
- •4. Histologically confirmed squamous cell carcinoma
- •5. naive for chemaotherapy and radiotherapy
- •6. Tumor T2-4, any N, M0 disease. Tumore must be considered resectable in a curative intent with a planned surgical excision
- •7. Last administration of a corticosteriod or an antihistamine >= 14 days prior to RO5083945/cetuximab infusion
排除标准
- •1. Carcinoma of nasal cavity, paranasal sinus and nasopharynx
- •2. Recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
- •3. Concurrent therapy with any other investigational product
- •4. Pregnant or lactating women
- •5. Hypersensitivity to the active substance or to any of the excipients
- •6. Uncontrolled diabetes
- •7. Poorly controlled hypertension
- •8. Patients with serious uncontrolled intercurrect illness including poorly controlled diabetes mellitus, active or uncontrolled infection
- •9. Known positivity for HIV, hepatitis B and /or hepatitis C infections
- •10. Any other disease that contraindicates the us eof an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- •11. Patients with dementia or altered mental status
- •12. Major surgery >= 4 weeks prior to study day 1
研究者
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