An open-label phase I study of AS-0141 in patients with advanced, metastatic, relapsed or refractory malignancies

Arimura Akinori0 个研究点目标入组 75 人开始时间: 2021年5月7日最近更新: 2024年4月23日

试验速览

暂无简介。

•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)

•- Patient with known high microsatellite instability(MSH-H)
•- Any of the following complicating desease
•1) Uncontrolled diabetes
•2) Interstitial pneumonia, pulumonary fibrosis, radiation pneumonia (including history)
•3) Active infection disease requiring systemic treatment such as antimicrobial agent, antivirus agent
•4) AML patients with leukocytosis over 30,000/mm^3 in peripheral leukocyte count
•- Any of following serious cardiac or cardiovascular condition
•1) Congestive heart failure
•2) Class III/ IV heart failure according to the New York Heart Association [NYHA] criteria
•3) 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
•4) Uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia)
•5) Uncontrolled hypertension
•6) Ischemic cerebrovascular accident (history of transient ischemic attack, arterial blood circulation reconstruction, etc.)

发起方

Arimura Akinori