NCT00486720终止2 期
A Randomized Phase IIa Study of Vorinostat in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 主要终点
- Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria
研究概览
简要总结
This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient is a male or female, at least 18 years of age with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) defined by the International Prognostic Scoring System
- •Patient has previously untreated disease, or has received up to one prior treatment regimen for lower-risk Myelodysplastic Syndrome
- •Patient has a performance status of equal to or less than 2 on the Eastern Cooperative Oncology Group Performance Scale
- •Patient must have adequate organ function
排除标准
- •Patient has clinical evidence of Central Nervous System (CNS) leukemia
- •Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
- •Patient had prior treatment with a histone deacetylase inhibitor
研究组 & 干预措施
1
Experimental
vorinostat 400 mg
干预措施: vorinostat (Drug)
2
Experimental
vorinostat 200 mg
干预措施: vorinostat (Drug)
结局指标
主要结局
Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria
时间窗: 2 Years
Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study.
Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.
时间窗: Every 21 days while on therapy and at 30 days after the last dose of study therapy
次要结局
未报告次要终点
研究者
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