A Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 483
- 试验地点
- 101
- 主要终点
- Progression-free Survival (PFS) Based on Central Independent Review
研究概览
简要总结
This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate
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
- None
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
Methotrexate
Weekly
干预措施: Methotrexate (Drug)
Afatinib (BIBW 2992)
Once daily
干预措施: Afatinib (Drug)
结局指标
主要结局
Progression-free Survival (PFS) Based on Central Independent Review
时间窗: From randomization until disease progression, death or study completion date (06Dec2016); Up to 60 months
PFS was defined as the time from the date of randomisation to disease progression or death, whichever occurred first. The primary analysis of PFS considered PFS events as assessed by central independent review, including all data collected until the study completion date (06 December 2016). The date of disease progression was recorded based on RECIST version 1.1. Unequivocal progression of disease was determined if at least one of the following criteria applied: * At least 20% increase in the Sum of Diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm * Appearance of one or more new lesions * Unequivocal progression of existing non-target lesions
次要结局
- Tumour Shrinkage(Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months)
- Overall Survival (OS)(From randomization until death or study completion date (06Dec2016); Up to 60 months)
- Time to Deterioration in Global Health Status(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Objective Response (OR)(Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months)
- Disease Control (DC)(Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months)
- Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Status Change in Pain Scale(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Status Change in Swallowing Scale(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Status Change in Global Health Status Scale(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Time to Deterioration in Pain(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Time to Deterioration in Swallowing(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)