NCT00371566已完成2 期
A Randomized, Single Blinded, Placebo-controlled, Multi-centre, Phase II Study of Lapatinib in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Change From Baseline of the Apoptotic Index During Treatment Phase
研究概览
简要总结
This is a study comparing the activity of lapatinib versus placebo followed by chemoradiation. This study is designed to explore the effects of lapatinib monotherapy on apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects with locally advanced squamous cell carcinoma of head and neck.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lapatinib
Experimental
干预措施: Lapatinib oral tablets (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline of the Apoptotic Index During Treatment Phase
时间窗: Baseline and Week 2
Apoptotic Index-TUNEL Assay is a method which counts a total of at least 1000 neoplastic nuclei(Cells with morphological changes defining cell death) subdivided in 10 fields chosen randomly at 400x magnification. A 'responder' was defined as having 20% cell death.
次要结局
- Change From Baseline of Cell Proliferation Rate of the Ki-67 Proliferative Index in Tumour Biopsy Samples During Treatment Phase(Baseline and Week 2)
- Overall Radiological Response After Treatment Phase in mITT Population(Baseline and End of Treatment (Week 2 - 6))
- Overall Radiological Response After Follow-up Phase in mITT Population(Baseline and End of Follow-up (Week 19 - 25))
- Overall Radiological Response After Treatment Phase in ITT Population(Baseline and End of Treatment (Week 2 - 6))
- Overall Radiological Response After Follow-up Phase in ITT Population(Baseline and End of Follow-up (week 19 - 25))
- Number of Circulating Tumor Cells at Baseline in mITT Population(Baseline)
- Relative Change From Baseline of Kep Mean (1/Min) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Relative Change From Baseline of Kep Perfused (1/Min) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Relative Change From Baseline of Kep Whole (1/Min) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Relative Change From Baseline of Ktrans Mean (1/Min) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Relative Change From Baseline of Ktrans Perfused (1/Min) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population(End of Treatment (week 2 - 6))
- Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population(End of Chemoradiotherapy (week 10 - 13))
- Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase(Baseline and Week 2)
- Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase(Week 2)
- Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase(Week 1 through Week 6)
- Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase(Week 10 through 25)
- Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information(Week 2 - 4)
- Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information(weeks 19 - 25)
- Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group(Week 1 through 25)
- Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase(Week 10 through 25)
- Summary of Serious Adverse Events During or After Chemoradiotherapy Phase(Week 10 through 25)
- Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase(Week 10 through 25)
- Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase(Week 10 through 25)
- Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase(Week 10 through 25)
- Relative Change From Baseline of Ktrans Median (1/Min) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Relative Change From Baseline of Ktrans Whole (1/Min) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Relative Change From Baseline of IAUC Median (90) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Relative Change From Baseline of IAUC Mean (90) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Relative Change From Baseline of Perfused IAUC (90) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Relative Change From Baseline of Whole IAUC(90) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
- Relative Change From Baseline of Kep Median (1/Min) After 2 - 4 Weeks of Treatment(Baseline, and Week 2 - 4)
研究者
研究点 (1)
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