JPRN-jRCT2080223734已完成1 期
A Phease1, Multicenter, Open-Label, Single Sequence Crossover Study to Evaluate Drug-Drug Interaction Potential of OATP1B/CYP3A Inhibitor on The Pharmacokinetics of DS-8201a in Subjects with HER2-Expressing Advanced Solid Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
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
- •1.Has a pathologically documented unresectable or metastatic solid malignant tumors with HER2 expression (determined by immunohistochemistry [IHC]/in situ hybridization [ISH] [IHC 3+, IHC 2+, IHC 1+, and/or ISH +], Next Generation Sequencing, or other analysis techniques as appropriate) that is refractory to or intolerable with at least 1 prior systemic chemotherapy regimen, or for which no standard treatment is available.
- •2. LVEF >= 50% .
- •3. Has an ECOG PS 0 or 1.
排除标准
- •1.Has a contraindication for receiving ritonavir or itraconazole according to the prescribing information.
- •2.Has a medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure.
- •3.Has complications of ventricular arrhythmia
研究者
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