NCT02062515Unknown2 期
Safety Assessment of Icotinib in Advanced NSCLC Patients With Hepatic Insufficiency: A Multi-center, Open-label, Single-arm Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The purpose of this study is to determine whether Icotinib is efficient and safe in treating advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.
详细描述
Patients with hepatic insufficiency is an important subgroup of who receive EGFR TKIs. Phase I/II studies showed that Icotinib has good security. Based on the above considerations, this single-arm, open-label study is designed to evaluate the safety of icotinib 125mg three times daily for histologically or cytologically confirmed NSCLC patients with hepatic insufficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of IIIB/IV stage NSCLC patients who are not suitable for surgery or radiotherapy
- •ECOG performance status points (PS) is 0-2
- •Liver function:
- •A (mild hepatic dysfunction):
- •A1) total bilirubin within normal limit (ULN), while AST> ULN;
- •A2) total bilirubin within1.0-1 .5 × ULN;
- •B (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × ULN
- •No malabsorption or other gastrointestinal disorders effecting drug absorption
- •Life expectancy: more than 12 weeks.
排除标准
- •Previous usage of HER/EGFR inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy )
- •Patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process .
- •Patients with active hepatitis and cirrhosis.
研究组 & 干预措施
Icotinib
Experimental
Icotinib is administered orally 125 mg three times per day continuously for four weeks
干预措施: icotinib (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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