JPRN-jRCT2080223752已完成2 期
A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced colorectal cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
研究概览
简要总结
Overall, DS-8201a demonstrated clinically meaningful response rates in subjects with HER2-overexpressing mCRC refractory to standard therapies. In the context of existing data available from current standard therapy in patient populations similar to those enrolled in this study, the efficacy and safety findings of this study warrant further development of DS-8201a in patients with HER2-overexpressing mCRC.
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
- •Age >= 20 years in Japan, >= 18 years in the rest of the countries.
- •- Pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma. Until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer.
- •- Received at least 2 prior regimens of standard treatment.
- •- 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
- •- Medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
- •- Has a medical history of clinically significant lung disease
- •- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
研究者
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