A Phase I/II, Open-Label, Multi-Center, Two-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD4877 Administered on Days 1, 2 and 3 in Adult Patients With Recurrent or Refractory Acute Myelogenous Leukemia (AML) Excluding Promyelocytic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR)
研究概览
简要总结
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML).
For enrollment information see the Central Contact information below
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
- •Part A: Relapsed or refractory leukemia for which no standard therapies are anticipated to result in a durable remission
- •Part B: AML who have had no more than two prior relapses or failed to achieve remission after at least one induction treatment.
- •Patients with prior allogeneic transplants who remain clinically stable for ≥2 weeks or more off immunosuppressive therapy
排除标准
- •Promyelocytic acute myelogenous leukemia
- •Prior allogeneic transplant requiring immunosuppressive therapy or treating physician does not consider patient to be a candidate for allogeneic transplantation.
- •Liver injury
结局指标
主要结局
To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR)
时间窗: Response is evaluated after a maximum of 2 courses of induction therapy.
Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.
To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs)
时间窗: Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period.
To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs)
To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ]
时间窗: PK samples are collected on Days 1, 2, 3, 24 and 48 hours following the end of Day 3 AZD4877 infusion and Day 8.
Maximum plasma concentration, Cmax
次要结局
- To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR)(Response is evaluated after a maximum of 2 courses of induction therapy.)
- To Evaluate the Safety and Tolerability of AZD4877 on a Daily x 3 Schedule by Assessment of Adverse Events, Non-hematologic Labs and Vital Signs(Patients were followed for safety from the date of first dose of AZD4877 up to 30-days after the last administration of AZD4877, where possible.)