JPRN-UMIN000029506已完成2 期
A clinical trial of DS-8201a in HER2 positive(HER2>=1) metastatic/recurrent uterine carcinosarcoma patients (NCCH1615,STATICE trial) - A clinical trial of DS-8201a in HER2 positive(HER2>=1) metastatic/recurrent uterine carcinosarcoma patients (NCCH1615,STATICE trial)
ational Cancer Center0 个研究点目标入组 34 人开始时间: 2017年10月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
研究概览
简要总结
The ORR by central review in the HER2-high and HER2-low groups were 54.5% (95% CI, 32.2 to 75.6) and 70.0% (95% CI, 34.8 to 93.3) and those by investigator assessments were 68.2% and 60.0%, respectively.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1) Active double cancer 2) Current or previous symptomatic congestive heart failure (NYHA class II to IV) or severe arrhythmia requiring treatment within 28 days before registration 3) Current or previous myocardial infarction or unstable angina within 6 months before registration 4) QTc >470 msec 5) Current or previous lung diseases such as interstitial pneumonitis,pulmonary fibrosis and severe radiation pneumonitis or current uncontrolled infection 6) HIV antibody-positive,HTLV-1 antibody-positive, HBs-antigen-positive,or HCV antibody-positive: except for HCV-RNA-negative even if HCV antibody-positive 7) Though HBs antigen-negative,HBs antibody-positive or HBc antibody-positive, and HCV-DNA quantitative test positive 8) Grade>=2 adverse reactions caused by prior therapy except any grade of alopecia and grade 2 peripheral neurotoxicity 9) Has confirmed hypersensitivity to the active ingredient of the investigational drug 10) Pregnant or breast-feeding women or women suspected of being pregnant 11) Psychiatric diseases or psychological symptoms interfering taking part in the trial
研究者
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