跳至主要内容
临床试验/NCT01244009
NCT01244009撤回2 期

A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma

Tesaro, Inc.0 个研究点开始时间: 2010年12月最近更新:
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

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

发起方
Tesaro, Inc.
申办方类型
Industry

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