NCT02783547撤回1 期
A Phase 1, Open Label, Multicentre Clinical Trial of SyB C-1101 in Combination With Azacytidine in Patients With Myelodysplastic Syndrome
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of dose-limiting toxicity (DLT) in patients administered with specified (level 1 or 2) dosage of SyB C-1101 in Cycle 1 and the descriptions of DLT
研究概览
简要总结
This is a Phase 1 clinical trial to evaluate the tolerability of a combination therapy of SyB C-1101 (rigosertib sodium) and Azacytidine and to determine the recommended dose of SyB C-1101for Phase 2 trial in patients with myelodysplastic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SyB C-1101 and Azacytidine
Experimental
干预措施: SyB C-1101 and Azacytidine (Drug)
结局指标
主要结局
Number of dose-limiting toxicity (DLT) in patients administered with specified (level 1 or 2) dosage of SyB C-1101 in Cycle 1 and the descriptions of DLT
时间窗: Up to 19 months
Incidence rate of DLT and its binomial proportion confidence interval at the 90% level definition of DLT are as below: 1) Non-hematotoxicity of grade 3 or above with the exception of fever 2) fever of grade 2 or above uncontrolled by antipyretics
次要结局
- Serious Adverse Events(Up to 19 months)
- Adverse Events, not including Serious Adverse Events(Up to 19 months)
- Change in laboratory values(Up to 19 months)
- Total efficacy in hematologic remission rate(Up to 19 months)
- Total efficacy in hematologic improvement rate(Up to 19 months)
- Cytogenetic response rate(Up to 19 months)
- Peak plasma concentration (Cmax)(Up to 19 months)
- Time to maximum drug concentration time (tmax)(Up to 19 months)
- Area under the plasma concentration-time curve (AUC)(Up to 19 months)
- Elimination half-life (t1/2)(Up to 19 months)
研究者
研究点 (1)
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