NCT03754244终止1 期
A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Dose-Limiting Toxicities（DLT）
研究概览
简要总结
To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a reasonable regimen for subsequent research.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •progressive or metastatic non-small cell lung cancer that diagnosed Pathologically or cytologically diagnosed patients who have received EGFR tyrosine kinase inhibitor monotherapy (e.g., gefetinib, erlotinib, ecotinib, afatinib) for disease progression EGFR T790M mutation was confirmed ECOG PS≤1 Adequate blood cell counts, kidney function and liver function Patients should participate in the study voluntarily and sign informed consent
排除标准
- •Patients with non-small-cell lung cancer who have received osimertinib or other raw materials or preparations for EGFRT790M mutant drugs Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication; Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C; Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history
研究组 & 干预措施
TQB3456
Experimental
p.o. qd
干预措施: TQB3456 (Drug)
结局指标
主要结局
Dose-Limiting Toxicities（DLT）
时间窗: Baseline up to 28 days
an adverse event cccurring after initiation of TQ-B3456 that met any following criteria： 1. \>=Grade 3 of non-hematology toxicity 2. Grade 4 hematology toxicity
次要结局
未报告次要终点
研究者
研究点 (1)
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