跳至主要内容
临床试验/NCT01454934
NCT01454934已完成3 期

A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer

Eisai Inc.0 个研究点目标入组 540 人开始时间: 2011年12月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Eisai Inc.
入组人数
540
主要终点
Overall Survival (OS)

研究概览

简要总结

This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

Arm A

Experimental

干预措施: Eribulin (Drug)

Arm B

Active Comparator

干预措施: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed (Drug)

结局指标

主要结局

Overall Survival (OS)

时间窗: Randomization (Day 1) until date of death from any cause, or 37 months

The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin mesylate and TPC was tested at a significance level of 0.05 (2-sided). Kaplan-Meier (K-M) survival probabilities for each arm were plotted over time. The treatment effect was estimated by fitting a Cox Proportional Hazards model to the OS times including treatment arm as a factor and histology, TPC option and geographic region as strata.

次要结局

  • Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)(Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months)
  • Objective Response Rate (ORR)(Randomization (Day 1) to CR or PR)

研究者

发起方
Eisai Inc.
申办方类型
Industry
责任方
Sponsor

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