NCT00260065已完成2 期
A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 99
- 主要终点
- Number of Participants Who Achieved Overall Response
研究概览
简要总结
The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.
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
- •Must sign an Institutional Review Board (IRB) -approved informed consent form.
- •Must be 18 years of age or older.
- •Must have a diagnosis for MDS fitting any of the recognized French-American-British (FAB) classifications and International Prognostic Scoring System (IPSS) greater than or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. If FAB classification is Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks.
- •If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
- •If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.
排除标准
- •Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.
- •Must not have received any investigational agent within the 30 days preceding the first dose of study drug.
- •Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.
- •Must not have an active viral or bacterial infection.
研究组 & 干预措施
1
Experimental
干预措施: Decitabine (Drug)
结局指标
主要结局
Number of Participants Who Achieved Overall Response
时间窗: 1 year
Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)
次要结局
- Best Response and Overall Improvement(1 year)
研究者
相似试验
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