NCT01244009撤回2 期
A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Tesaro, Inc.
- 主要终点
- Number of participants who have a complete response (CR) or partial response (PR) during the study
研究概览
简要总结
This study will investigate the efficacy and safety of MK-4827 in participants with relapsed mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the Ataxia-Telangiectasia Mutated (ATM) gene.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MK-4827
Experimental
All Participants
干预措施: MK-4827 (Drug)
结局指标
主要结局
Number of participants who have a complete response (CR) or partial response (PR) during the study
时间窗: Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond
次要结局
- Number of Participants with adverse events(From the day of enrollment through 30 days after the last dose of study drug)
- Time from allocation to disease progression or death from any cause (Progression-free survival)(Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond)
研究者
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