JPRN-jRCT2080223254已完成1 期
Phase 1b, open-Label, dose escalation study of quizartinib in combination with induction and consolidation chemotherapy in Japanese patients with newly diagnosed acute myeloid leukemia (AML)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
This study demonstrated that doses of quizartinib 20 mg once daily or 40 mg once daily in combination with standard chemotherapy are generally well-tolerated. The Cmax and AUCtau values of quizartinib, AC886, and quizartinib + AC886 increased as dose increased within the dose range tested. The pharmacokinetic profiles of quizartinib and AC886 were similar to those in the previous study which conducted in overseas.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •No prior treatment for AML (including quizartinib)
- •-ECOG Performance Status (PS) of 0 to 2
排除标准
- •-Diagnosis of acute promyelocytic leukemia
- •-Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy
研究者
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