EUCTR2017-003466-28-IT进行中（未招募）1 期
A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced colorectal cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Pathologically documented unresectable, recurrent, or metastatic
- •colorectal adenocarcinoma. Until sponsor's notification to the study
- •sites, subject must be a (BRAF) wild-type cancer.
- •2. Received at least 2 prior regimens of standard treatment.
- •3. Has measurable disease assessed by the investigator based on RECIST
- •version 1.1.
- •4. Has an Eastern Cooperative Oncology Group Performance Status (ECOG
- •PS) of 0 to 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Medical history of myocardial infarction within 6 months before enrollment (study treatment), symptomatic congestive heart failure
- •2 Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- •3. 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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