The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Safety and Tolerability of extended treatment with tosedostat
研究概览
简要总结
The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.
详细描述
Extension protocol to the OPAL Study (CHR-2797-038).
Study mimics normal clinical practice; few procedures and visits are therefore mandated by the protocol. Timing of bone marrow assessment is also left at the investigator's discretion.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed, informed consent
- •Completion of Visit 11 in the OPAL Study (Month 6 Visit)
- •Investigator's opinion that the subject would benefit from continued therapy with tosedostat.
排除标准
- •Any co-existing medical condition that in the Investigator's opinion will substantially increase the risk associated with the subject's participation in the study
- •Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- •Administration of any (other) investigational agent within 14 days of entry into TOPAZ.
研究组 & 干预措施
Tosedostat
干预措施: CHR-2797 (Drug)
结局指标
主要结局
Safety and Tolerability of extended treatment with tosedostat
时间窗: Protocol mandated visits every 12 weeks
Primary outcome will be assessed using the following procedures/data: * Physical exams * Vital signs * Electrocardiography * Laboratory parameters (hematology, chemistry, urinalysis) * Adverse events * Serious adverse events
次要结局
- Efficacy of extended treatment with tosedostat(Protocol-mandated visits every 12 weeks)