JPRN-jRCT2080223057已完成1 期
Phase 1 Study of DS-6051b in Japanese Subjects with Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
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
- •Advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available.
- •-An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
排除标准
- •-Previously had or currently has any of the following diseases:
- •Cardiac failure (NYHA Functional Classification >= Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment.
- •-Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia).
- •-Severe or uncontrolled concomitant disease.
- •-Clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.
研究者
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