jRCT2031210072招募中不适用
An open-label phase I study of AS-0141 in patients with advanced, metastatic, relapsed or refractory malignancies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 85
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Aged >18 years at time of informed consent
- •Histlogically confirmed solid tumors, AML, MDS, or DLBCL for which no standard therapy is available
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) <= 1 (solid tumors and DLBCL) or <= 2 (AML and MDS)
- •Life expectancy at least 3 months (90days)
排除标准
- •Patient with known high microsatellite instability(MSH-H)
- •Any of the following complicating desease
- •Uncontrolled diabetes
- •Interstitial pneumonia, pulumonary fibrosis, radiation pneumonia (including history)
- •Active infection disease requiring systemic treatment such as antimicrobial agent, antivirus agent
- •AML patients with leukocytosis over 30,000/mm^3 in peripheral leukocyte count
- •Any of following serious cardiac or cardiovascular condition
- •Congestive heart failure
- •Class III/ IV heart failure according to the New York Heart Association [NYHA] criteria
- •Ischemic myocardial disease (angina pectoris which needs treatment or revascularization, miocardinal infarction, unstable and symptomatic ischemic heart disease, etc) within 6 months before study drug administration
- •Uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia)
- •Uncontrolled hypertension
- •Ischemic cerebrovascular accident (history of transient ischemic attack, arterial blood circulation reconstruction, etc.)
结局指标
主要结局
-
Dose limiting toxicity
次要结局
未报告次要终点
研究者
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