A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Time to maximum observed concentration of AMG 900
研究概览
简要总结
This study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK (pharmacokinetics) of oral AMG 900 in subjects with acute myeloid leukemia. Up to 93 subjects may be enrolled in dose escalation. The dose expansion part of the study will consist of 20 subjects with acute myeloid leukemia. The dose of AMG 900 will be dependent upon data from the dose escalation part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥ 18 years old
- •Pathologically documented, definitively diagnosed AML that has failed standard treatments or for which no standard therapy is available or the subject refuses standard therapy
- •Must consent to undergo bone marrow biopsies per schedule of assessments
排除标准
- •White blood cell greater than 20,000 uL
- •History of or active central nervous system leukemia
- •Prior allogeneic bone marrow transplant
- •Subject will not be available for protocol-required study visits or procedures
- •Other Inclusion/ Exclusion Criteria may apply to qualify for enrollment
研究组 & 干预措施
Arm 1- Dose Escalation
The dose escalation will be conducted in 2 parts. Group 1 will consist of 8 cohorts and Group 2 will consist of 5 cohorts. The dose escalation is aimed at determining the maximum tolerated dose (MTD) of AMG 900.
干预措施: Arm 1- Dose Escalation (Drug)
Arm 2- Dose Expansion
The dose expansion part of the study will begin after completion of the dose escalation phase and will consist of 20 subjects with acute myelogenous leukemia.
干预措施: Arm 2- Dose Expansion (Drug)
结局指标
主要结局
Time to maximum observed concentration of AMG 900
时间窗: 1 year
Subject incidence of adverse events
时间窗: 1 year
Subject incidence of dose limiting toxicities (DLTs)
时间窗: 1 year
Maximum observed concentration of AMG 900
时间窗: 1 year
Area under the plasma concentration-time curve (AUC) of AMG 900
时间窗: 1 year
Half life of AMG 900
时间窗: 1 year
次要结局
- Objective response as per Cheson Response Criteria(1 year)
- Change in the number of p-Histone H3 positive cells from baseline(1 year)