NCT04179656Unknown2 期
An Open-label, Phase 2 Study of Pyrotinib Maleate in Advanced Solid Tumors Patients With HER2( Erb-B2 Receptor Tyrosine Kinase 2)-Postive
Tianjin Medical University Second Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is an open-label, Phase 2 study exploring the efficacy and safety of 马来酸 Pyrotinib Maleate Tablets in patients with solid tumors with activating（harmful） HER2 mutations or with HER2 gene amplification or immunohistochemical staining (IHC) assay showing HER2 is 3+ and / or fluorescence in situ hybridization (FISH) positive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •There is a third interstitial fluid that cannot be controlled by drainage or other methods, such as pleural effusion and ascites;
- •It has many factors affecting the oral and absorption of drugs (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea and intestinal obstruction);
- •Those who have been confirmed to be allergic to the drug components of this program;
- •Patients who are known to be pregnant or planning to become pregnant, or gestational age patients who are unwilling to take effective contraceptive measures throughout the trial;
- •Patients with severe concomitant diseases or those considered by the investigator to be unsuitable for inclusion.
- •The investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of the study (for administrative reasons or for other reasons).
研究组 & 干预措施
Pyrotinib Treatment
Experimental
This arm for HER2-postive solid tumor
干预措施: Pyrotinib (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: at least 3 months
Objective response rate defined as the patients confirmed complete response or partial response under RECIST 1.0 criteria.
次要结局
- Progression free survival(up to 24 months)
- Duration of Response(up to 24 months)
- Safety (Adverse Events and Serious Adverse Events)(up to 36 months)
- Disease Control Rate(up to 24 months)
- Overall Survival(up to 36 months)
研究者
研究点 (1)
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