A Phase II, Double-blind, Placebo Controlled, Randomised Study to Assess the Efficacy and Safety of ZD4054 (Zibotentan) in Combination With Pemetrexed (Alimta®) vs. Pemetrexed Alone in Patients With Non-small Cell Lung Cancer Who Have Failed One Prior Platinum-based Chemotherapy Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Time to Death
研究概览
简要总结
The aim of this study is to collect initial efficacy and safety data on the use of a new treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment with pemetrexed alone
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC on entry into study suitable for pemetrexed therapy
- •Patients that meet one of the following criteria: - progressed following one prior platinum-based chemotherapy regimen for locally advanced or metastatic disease; -progressed within 6 months of adjuvant platinum-based chemotherapy
- •Life expectancy of > 12 weeks
排除标准
- •Prior treatment with pemetrexed in the last 12 months.
- •Prior therapy with an ET receptor antagonist
- •Any recent surgery, unhealed surgical incision, severe concomitant medical condition (eg, unstable cardiac, hepatic or renal disease) or significant laboratory finding which makes it undesirable for the patient to participate
研究组 & 干预措施
1
ZD4054 + Pemetrexed
干预措施: ZD4054 (Drug)
1
ZD4054 + Pemetrexed
干预措施: Pemetrexed (Drug)
2
ZD4054 matched placebo + pemetrexed
干预措施: Pemetrexed (Drug)
2
ZD4054 matched placebo + pemetrexed
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Death
时间窗: Patients were followed up for survival every week for the first 3 weeks then every 3 weeks whilst on study medication until the data cut-off (17th January 2010).
Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)
次要结局
- Progression-free Survival(Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation)