EUCTR2005-002485-11-GR进行中（未招募）不适用
A Randomized, Single Blind, Placebo-controlled, Multi-centre, Phase II Study of Lapatinib in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
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.Willing and able to sign a written informed consent.
- •2.Histologically or cytologically confirmed diagnosis of SCCHN.
- •3.Stage III, IVA and IVB disease will be eligible, who are to receive chemoradiation therapy as primary treatment (total dose = 66 Gy). Subjects with distant metastases (stage IVC) will be excluded.
- •4.Willing and able to have a tumour biopsy taken at screening and a second tumour biopsy taken during lapatinib/placebo administration.
- •5.Male or female 18 years of age.
- •6.ECOG performance status 0, 1 or 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.Subjects with paranasal sinuses and nasal cavity tumours;
- •2.Subjects who have received prior systemic chemotherapy given with curative intent;
- •3.Subjects who received prior radiotherapy;
- •4.Prior or concurrent treatment with tyrosine kinase inhibitors;
- •5.Use of any investigational agent within 30 days or 5 half-lives, whichever is longer, preceding the first dose of lapatinib;
- •6.Concurrent use of CYP3A4 inducers or inhibitors;
- •7.Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
- •8.Distant metastases, ie Stage IVC;
- •9.Subjects taking any prohibited medication
研究者
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