A Phase IIIb, Non-randomized, Open-label, Two-cohort Study in Patients With EGFR Mutations-positive Advanced Adenocarcinoma of the Lung, Assessing the Utility of the Afatinib Diarrhea Assessment and Management Guidelines (ADAM)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 12
- 主要终点
- Occurence of CTCAE Grade >= 2 Diarrhea
研究概览
简要总结
This is a non-randomized, open label, two-cohort, multi-institutional study to evaluate the use of diarrheal management tools intended to facilitate timely intervention and treatment modifications due to afatinib treatment-related diarrhea in patients with EGFR mutations-positive adenocarcinoma of the lung. Patients in Cohort 1 will follow diarrhea management. Patients in Cohort 2 will receive prophylactic loperamide starting the fist day of afatinib treatment.
研究设计
- 研究类型
- Interventional
- 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
Afatinib 40 mg + Loperamide (Cohort 1)
afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
干预措施: afatinib (Drug)
Afatinib 40 mg + Loperamide (Cohort 1)
afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
干预措施: loperamide (Drug)
Afatinib 40 mg + loperamide prophylactic (Cohort 2)
afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
干预措施: afatinib (Drug)
Afatinib 40 mg + loperamide prophylactic (Cohort 2)
afatinib starting 40 mg daily; Cohort 1 will receive loperamide at first sign of diarrhea; Cohort 2 will receive loperamide starting C1D1.
干预措施: loperamide (Drug)
结局指标
主要结局
Occurence of CTCAE Grade >= 2 Diarrhea
时间窗: From first drug administration until 28 days after the end of third treatment course, up to 84 days.
Overall incidence of patients who experienced diarrhea during the first three courses of afatinib treatment.
次要结局
- Time to Initial Onset of Diarrhea Grade 2 or Higher(From first drug administration until end of third treatment course, up to 84 days.)
- Duration of First Episode of Diarrhea Grade 2 or Higher(From first drug administration until end of third treatment course, up to 84 days.)
- Changes in Intensity of Diarrhea Over Time(Up to 12 weeks (equivalent to 3 courses))
- PFS(Every 08 weeks during the first 6 months of treatment, and every 12 weeks thereafter until the end of treatment.)