NCT03337451已完成1 期
Follow up Protocol to the Open Label Phase I/II Study OPN-305-106: A Prospective, Open Label Phase I/II Study to Assess the Safety and Efficacy of Cycles of Intravenously Infused Doses of OPN-305 in Second-line and Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Incidence and types of Serious Adverse events
研究概览
简要总结
This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main study OPN-305-106.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the OPN-305-106 study
- •Principal Investigator adjudicated efficacy response defined as either transfusion independence", "stable disease", "minor HI-E response" or "major HI-E response" and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine.
- •Provide written informed consent for the follow up protocol.
排除标准
- •Refusal to provide written informed consent
- •Withdrawal from the OPN-305-106 study prior to the final EOT visit
- •Plan to be included into another interventional investigational study.
- •Progression of disease
研究组 & 干预措施
OPN-305
Experimental
干预措施: OPN-305 (Drug)
结局指标
主要结局
Incidence and types of Serious Adverse events
时间窗: monthly through study completion, an average of 18 months
monitor ongoing efficacy responses
时间窗: monthly through study completion, an average of 18 months
To monitor ongoing efficacy responses defined as "transfusion independence". Transfusion independence is defined as 56 consecutive days where no RBC transfusions are given
次要结局
未报告次要终点
研究者
研究点 (1)
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