A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of AMG 232
研究概览
简要总结
Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.
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 is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
- •Ability to take oral medications and willing to record daily adherance to investigational product
- •Adequate hematological, renal, hepatic, and coagulation laboratory assessments
排除标准
- •Active infection requiring intravenous (IV) antibiotics
- •Prior participation in an investigational study (procedure or device) within 21 days of study day 1
- •Major surgery within 28 days of study day 1
- •Anti-tumor therapy within 14 days of study day 1
研究组 & 干预措施
AMG 232
AMG 232 is an anti-cancer agent
干预措施: AMG 232 (Drug)
AMG 232
AMG 232 is an anti-cancer agent
干预措施: Trametinib (Drug)
AMG 232 & Trametinib
AMG 232 and Trametinib are anti cancer agents
干预措施: Trametinib (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of AMG 232
时间窗: 36 months
To evaluate the safety and tolerability of AMG 232 by reviewing clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled.
Characterize the pharmacokinetics of AMG 232 alone and in combination with trametinib when administered orally.
时间窗: 36 months
PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax).
Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible.
时间窗: 36 months
The MTD is defined at the highest dose level with an observed incidence of dose limiting toxicity in \< 33% of subjects enrolled in a cohort.
次要结局
- Treatment Response(36 months)