JPRN-jRCT2080222926已完成1 期
Phase 1 study of DS-8201a in subjects with advanced solid malignant tumors
DAIICHISANKYO Co.,Ltd., DAIICHI SANKYO, INC.0 个研究点目标入组 278 人开始时间: 2015年7月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 278
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. Age >= 20 years in Japan, >= 18 years in the United States.
- •2. Eastern Cooperative Oncology Group performance status(PS) of 0 or 1.
- •3. Left ventricular ejection fraction (LVEF) >= 50%
- •1. Advanced/unresectable or metastatic breast cancer or gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- •1. Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- •2.Treated with T-DM1
- •1. Advanced gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- •2. Treated with trastuzumab
- •1. Advanced breast cancer with HER2 low expression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- •Satisfy at least one of the following criteria
- •1. Advanced/unresectable or metastatic solid malignant tumor with HER2 expression other than breast cancer and gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- •2. Advanced/unresectable or metastatic tumor with HER2 mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- •1. Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- •2. Treated with ado-trastuzumab emtansine (T-DM1) (patients with HER2 overexpression only)
排除标准
- •1.Has a medical history of symptomatic CHF (New York Heart Association; NYHA classes II-IV) or serious cardiac arrhythmia.
- •2.Has a medical history of myocardial infarction or unstable angina.
- •3.Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
- •4.Has a medical history of clinically significant lung diseases
研究者
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