NCT01084330已完成2 期
A Randomized, Open-label, Multi-center Phase II Study to Compare AUY922 With Docetaxel or Irinotecan in Adult Patients With Advanced Gastric Cancer, Who Have Progressed After One Line of Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 8
- 主要终点
- Progression Free Survival
研究概览
简要总结
A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.
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
- 否
入选标准
- •Radiologically confirmed advanced gastric cancer
- •One previous line of chemotherapy
- •Progressive disease
- •One measurable lesion
- •Blood tests within protocol ranges
- •(WHO) Performance Status ≤ 1
- •Able to sign informed consent
排除标准
- •No symptomatic brain metastases
- •No coumarin type anticoagulants
- •No liver or kidney disease
- •No impaired heart function
- •No pregnant or lactating women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AUY922
Experimental
干预措施: AUY922 (Drug)
Docetaxel or Irinotecan
Active Comparator
干预措施: Docetaxel (Drug)
Docetaxel or Irinotecan
Active Comparator
干预措施: Irinotecan (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 21 day cycle: treatment until death, lost to follow up or withdrawal
次要结局
- Estimate of the Overall Survival Treatment Effect to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.(21 day cycle: treatment until death, lost to follow up or withdrawal)
- Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.(21 day cycle: treatment until death, lost to follow up or withdrawal)
- Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922(21 day cycle: treatment until death, lost to follow up or withdrawal)
研究者
研究点 (8)
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