JPRN-jRCT2080223671已完成2 期
A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 233
研究概览
简要总结
The efficacy and safety findings of this study demonstrated the positive benefit/risk ratio of DS-8201a in HER2 positive patients with advanced gastric or GEJ adenocarcinoma who have progressed on 2 or more regimens including fluoropyrimidine agent, platinum agent, and trastuzumab. DS-8201a demonstrated antitumor activity in patients with HER2-low (IHC 2+/ISH-, IHC 1+) advanced gastric or GEJ adenocarcinoma
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
- •Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction.
- •- Progression on and after at least 2 prior regimens which had to include a fluoropyrimidine and a platinum.
- •- Has measurable disease assessed by the investigator based on RECIST version 1.1.
- •- Has an ECOG PS of 0 to 1
排除标准
- •- Has a medical history of clinically significant lung disease
- •- Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy
- •- Has had non-gastric or gastroesophageal junction primary malignancies within 3 years
研究者
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