Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Eisai Inc.
- 入组人数
- 41
- 试验地点
- 3
- 主要终点
- Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS.
研究概览
简要总结
The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).
详细描述
Phase I: The purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS
Phase II: To evaluate hematological responses at the dose selected in the Phase I portion of the study.
Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due to a change in product development strategy
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).
排除标准
- •Prior therapy with decitabine or azacytidine (Vidaza).
- •Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.
- •Clinically significant anemia.
- •Prior history of malignancy other than MDS.
- •Any active infection.
- •Radiotherapy within 14 days prior to study enrollment.
研究组 & 干预措施
DACO-019 2mg/m^2
DACO-019 2mg/m^2 twice daily (BID)
干预措施: Subcutaneous Decitabine (Drug)
DACO-019 5mg/m^2
DACO-019 5mg/m^2 BID
干预措施: Subcutaneous Decitabine (Drug)
DACO-019 10mg/m^2
DACO-019 10mg/m^2 BID
干预措施: Subcutaneous Decitabine (Drug)
结局指标
主要结局
Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS.
时间窗: Up to 8 cycles (224 days)
Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study.
时间窗: Up to 12 cycles (336 days)
次要结局
未报告次要终点