NL-OMON55859已完成不适用
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 - 20120252-Phase 1 Study of AMG330 in Subjects With Myeloid Malignancies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 10
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects >= 18 years of age, AML as defined by the WHO Classification,
- •persisting or recurring following one or more treatment courses,
- •relapsed/refractory AML: blasts in bone marrow >5%, Eastern Cooperative
- •Oncology Group Performance Status of <= 2
- •Please see protocol section 4.1 for the full list.
排除标准
- •Known hypersensitivity to immunoglobulins or to any other component of the IP
- •formulation (eg, sucrose, polysorbate 80, citrate, lysine), Prior malignancy
- •(other than in situ cancer) unless treated with curative intent and without
- •evidence of disease for > 1 years before screening, History or evidence of
- •cardiovascular risk, History of arterial thrombosis in the past 3 months
研究者
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