A Phase 1, Open-Label, Dose Escalation Study of Quizartinib, An Oral FLT3 Inhibitor, in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Cmax,ss of quizartinib and its active metabolite
研究概览
简要总结
This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory AML
- •AML for which no standard treatment is available
- •ECOG Performance Status (PS) of 0 to 2
排除标准
- •Acute Promyelocytic Leukemia
- •chronic myelogenous leukemia in blast phase (BCR-ABL fusion gene positive)
- •History of other malignancies within 3 years prior to enrollment, except curatively treated in-situ carcinoma, AML, or MDS.
研究组 & 干预措施
AC220
This study will follow a mCRM (modified continual reassessment method) + EWOC (Escalation with Overdose Control) design.
干预措施: AC220 (Drug)
结局指标
主要结局
Cmax,ss of quizartinib and its active metabolite
时间窗: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
AUCtau,ss of quizartinib and its active metabolite
时间窗: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
number of subjects experiencing adverse events
时间窗: first dose to follow-up, approximately 1 year
Cmax of quizartinib and its active metabolite
时间窗: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
Tmax of quizartinib and its active metabolite
时间窗: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
Ctrough of quizartinib and its active metabolite
时间窗: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
Tmax,ss of quizartinib and its active metabolite
时间窗: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
AUCtau of quizartinib and its active metabolite
时间窗: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss.
次要结局
- bone marrow findings(Cycle 1: Days 15, 28; Cycle 2 and on: Day 28)
- FMS-like tyrosine kinase-3 / internal tandem duplication FLT3/ITD allelic ratio(Cycle 1: Days 1, 2, 8, 15)
- PIA assessment(Cycle 1: Days 1, 2, 8, 15)
- absolute neutrophil count(Cycle 1: Days 15, 28; Cycle 2 and on: Day 28)
- platelet count(Cycle 1: Days 15, 28; Cycle 2 and on: Day 28)