JPRN-jRCT2080223088已完成1 期
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
研究概览
简要总结
Quizartinib multiple-dose monotherapy was well tolerated in Japanese relapsed or refractory AML patients at doses up to 60 mg/day, and the MTD was higher than 60 mg/day.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
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 crisis (BCR-ABL fusion gene positive)
- •-History of other malignancies within 3 years prior to enrollment, except curatively treated in-situ carcinoma, AML, or MDS.
研究者
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