JPRN-jRCT2071210044暂停1 期
A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 256
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Informed consent provided
- •2. 18 years or older
- •3. Relapsed/refractory AML: AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML)
排除标准
- •1. Active extramedullary AML in testes or central nervous system (CNS)
- •2. Known hypersensitivity to immunoglobulins or to any other component of the IP formulation (eg, sucrose, captisol, potassium, polysorbate 80, citrate, lysine)
- •3. Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for more than 1 years before screening
研究者
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