A Study to Evaluate the Safety and Pharmacokinetics of Quizartinib in Combination With Standard Induction Therapy and Consolidation Therapy in Chinese Patients With Newly Diagnosed Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Participants with Dose-Limiting Toxicities
研究概览
简要总结
20 mg or 40 mg of quizartinib will be given to Chinese patients who were just diagnosed with AML. The study drug will be given to them along with standard therapies. The purpose is to find out the highest dose they can stand.
详细描述
This is a Phase 1, multicenter, open-label study to evaluate the safety and pharmacokinetics (PK) of quizartinib in combination with standard induction therapy and consolidation therapy in Chinese patients with newly diagnosed AML.
The quizartinib doses will be Level 1: 20 mg and Level 2: 40 mg. No increase in the quizartinib dose will be made in the same subject.
Dose-limiting toxicity associated with quizartinib occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a 3 + 3 design.
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 70 Years（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
Quizartinib 20 mg
Participants receive 20 mg quizartinib in combination with standard induction therapy and consolidation therapy once daily in the fasted state in the morning (at least 1 hour before or two hours after a meal)
干预措施: Quizartinib (Drug)
Quizartinib 40 mg
Participants receive 40 mg quizartinib in combination with standard induction therapy and consolidation therapy once daily in the fasted state in the morning (at least 1 hour before or two hours after a meal)
干预措施: Quizartinib (Drug)
结局指标
主要结局
Number of Participants with Dose-Limiting Toxicities
时间窗: At the end of induction phase at approximately 56 days
Maximum Concentration (Cmax)
时间窗: within 56 days
Categories: quizartinib, active metabolite
Number of Participants with Adverse Events During the Trial
时间窗: within approximately 19 months
Time to Cmax (Tmax)
时间窗: within 56 days
Categories: quizartinib, active metabolite
Area under the Plasma Concentration-Time Curve (AUC)
时间窗: within 56 days
Categories: quizartinib, active metabolite
次要结局
- Number of Participants with Response(within approximately 19 months)
- Response Rates(within approximately 19 months)