NCT01239108撤回1 期
A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects With Relapsed/Refractory Leukemias
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort
研究概览
简要总结
Dose escalation study for subjects with Leukemia that has returned or has not responded to standard treatment.
详细描述
A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGI-1776, a PIM Kinase Inhibitor, in Subjects with Relapsed/Refractory Leukemias
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with a confirmed diagnosis of leukemia unresponsive to curative therapy
- •Eastern Cooperative Oncology Group performance status of 0 to 2
- •Total bilirubin ≤ 1.5 X upper limit of normal (ULN); aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤ 3 X ULN; serum creatinine ≤ 2 X ULN
- •Normal cardiac function with left ventricular ejection fraction ≥ 50% at screening
- •No clinically significant abnormalities on screening electrocardiogram (ie, QTc interval must be < 470 msec for women and < 450 msec for men and no history of torsades de pointes)
- •No reproductive potential or willing to use 2 methods of contraception during the study and for 30 days after the last dose
- •Able to understand the purpose and risks of the study and provide informed consent and authorization to use protected health information
排除标准
- •A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral SGI-1776, or put the study outcomes at undue risk
- •Significant cardiovascular disease
- •Malabsorption syndrome
- •Symptomatic central nervous system metastases or lesions for which treatment is required
- •Received prior radiation therapy within 4 weeks of first dose
- •Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation
- •Treatment with any investigational drug within 3 weeks of the first dose
- •Use of systemic corticosteroids (other than for premedications or intermittent doses such as those used for allergic reactions and control of asthma) or myelosuppressive chemotherapy within 2 weeks of the first dose treatment with nitrosoureas or mitomycin C within 3 weeks of the first dose of SGI 1776
- •Uncontrolled active systemic infections
结局指标
主要结局
The MTD as determined by the incidence of DLTs in the first 4 weeks of each dosing cohort
时间窗: July 2011
次要结局
- • Frequency, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) •(1 year)
研究者
研究点 (1)
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