JPRN-jRCT2080223735已完成1 期
Phase 1, Multicenter, Open-Label, Multiple-Dose Study of DS-8201a to Assess the Effect on the QT Interval, and Pharmacokinetics in Subjects with HER2-Expressing Metastatic and/or Unresectable Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
研究概览
简要总结
This study characterized the PK profile of DS-8201a after multiple dosing and demonstrated that DS-8201a has no clinically meaningful impact on the QTc interval. Furthermore, the results of this study support a manageable safety profile and antitumor activity of DS-8201a in patients with HER2-expressing metastatic and/or unresectable BC.
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 breast cancer with HER2 expression (immunohistochemistry [IHC] 3+, IHC 2+, IHC 1+ and/or in situ hybridization [ISH]* +) that is refractory to or intolerable with standard treatment, 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 medical history of myocardial infarction within 6 months before enrollment.
- •2. Has a medical history of ventricular arrhythmias, other than rare, occasional premature ventricular contractions.
- •3. Has uncontrolled or significant cardiovascular disease,
研究者
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