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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen K.K.
- 入组人数
- 256
- 主要终点
- Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
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
- Non-randomized Controlled Trial
- 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
- •Informed consent provided
- •18 years or older
- •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
- •Active extramedullary AML in testes or central nervous system (CNS)
- •Known hypersensitivity to immunoglobulins or to any other component of the IP formulation (eg, sucrose, captisol, potassium, polysorbate 80, citrate, lysine)
- •Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for more than 1 years before screening
结局指标
主要结局
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
时间窗: Day 1 to Day 14
A participant was not DLT-evaluable if they dropped out before completion of the DLT window (14 days) for reasons other than an adverse event related to study drug or the participant had not received investigational product (IP) treatment for at least 14 days at the target dose for a 3- or 4-week cycle or at least 7 days at a target dose for a 2- week cycle. Furthermore, following drug interruptions, if a participant was unable to complete 2 repeat cycles for reasons other than DLT, the participant was not DLT evaluable.
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
时间窗: Day 1 until 30 days after last dose. Median duration of treatment was: Group 1 - 29.0 days; Group 2 - 29.0 days; Group 3 - 49.50 days; Group 4 - 23.50 days
The severity of TEAEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria. The general guideline for assessment ranged from Grade 1 to 5, with higher grades indicating a worse outcome, and included: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 = death.
次要结局
- Number of Participants Who Experienced an Incident of Anti-AMG 330 Antibody Formation(Baseline until the end of study, up to approximately 6 months)
- Response Rate in Participants With R/R AML(From first dose of IP (Day 1) until the end of study, up to approximately 6months)
- Response Rate in Participants With MRD-positive AML(From first dose of IP (Day 1) until the end of study, up to approximately 6 months)
- Response Rate in Participants With MDS(From first dose of IP (Day 1) until the end of study, up to approximately 6 months)
- Duration of Response(From fi rst dose of IP (Day 1) until the end of study, up to approximately 6 months)
- Time to Response(From fi rst dose of IP (Day 1) until the end of study, up to approximately 6 months)
- Event-free Survival(From fi rst dose of IP (Day 1) until the end of study, up to approximately 6 months)
- Overall Survival(Baseline until the end of study, up to approximately 6 months)