A Phase I Tolerance, Safety and Efficacy Study of Alkotinib in Patients With Advanced ALK Positive /ROS1 Positive NSCLC and Previously Treated With Chemotherapy or Crizotinib
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- MTD
研究概览
简要总结
To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.
详细描述
The study is a randomized, double-blind phase 1 trial including 2 sequential parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part. SAD and MAD are dose-escalated tolerant study designing. The aims of the study as below:
- Evaluating the safety and tolerance of ZG0418 in ALK+ NSCLC.
- Evaluating the fasting pharmacokinetic parameters of ZG0418 in ALK+ NSCLCJaktinib.
- Evaluating the postprandial pharmacokinetic parameters of ZG0418 in ALK+ NSCLC.
- Analysis the metabolites of ZG0418
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to
- •Life expectancy of at least 12 weeks.
- •Ability to swallow and retain oral medication.
- •Adequate organ system function, defined as follows:
- •Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
- •Platelets ≥75 x 10^9/L
- •Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level
- •Total bilirubin ≤1.5 times the upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- •≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.
- •Creatinine 1.5 x ULN.
- •Brain metastases allowed if asymptomatic at study baseline.
- •Patients must have measurable disease per RECIST v. 1.1.
排除标准
- •chemotherapy, radiation therapy, immunotherapy within 4 weeks.
- •Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
- •uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.
研究组 & 干预措施
ZG0418 200mg QD
ZG0418 200mg/day,oral
干预措施: Alkotinib (Drug)
ZG0418 300mg QD
ZG0418 300mg/day,oral
干预措施: Alkotinib (Drug)
ZG0418 400mg QD
ZG0418 400mg/day,oral
干预措施: Alkotinib (Drug)
ZG0418 500mg QD
ZG0418 500mg/day,oral
干预措施: Alkotinib (Drug)
ZG0418 600mg QD
ZG0418 600mg/day,oral
干预措施: Alkotinib (Drug)
结局指标
主要结局
MTD
时间窗: Day1 to Day25
Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated Alkotinib
次要结局
未报告次要终点