EUCTR2016-004986-18-FR进行中（未招募）1 期
A Phase 2, Multicenter, Open-Label Study of DS-8201a, anAnti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive,Unresectable and/or Metastatic Breast Cancer Subjects Who areResistant or Refractory to T-DM1.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 253
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
- •Men or women the age of majority in their country
- •Has pathologically documented breast cancer that:
- •1.is unresectable or metastatic
- •2.has HER2 positive expression confirmed per protocol
- •Has an adequate tumor sample
- •Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •Has protocol-defined adequate cardiac, renal and hepatic function
- •Agrees to follow protocol-defined method(s) of contraception
- •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 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
- •Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
- •Has a medical history of clinically significant lung disease
- •Is suspected to have certain other protocol-defined diseases based on imaging at screening period
- •Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
- •1.safety or well-being of the participant or offspring
- •2.safety of study staff
- •3.analysis of results
研究者
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