A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
2014年5月27日 更新者：Boehringer Ingelheim
An Open Label, Partially Randomised Phase II Study to Investigate the Efficacy and Safety of BIBW 2992 in Patients With Metastatic Colorectal Cancer Who Never Received Prior Anti-EGFR (Epidermal Growth Factor Receptor) Treatment
This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan.
Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past.
Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab.
Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992.
The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.
研究概览
研究类型
介入性
注册 (实际的)
94
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Bournemouth、英国
- 1200.74.44001 Boehringer Ingelheim Investigational Site
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Bristol、英国
- 1200.74.44005 Boehringer Ingelheim Investigational Site
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Cambridge、英国
- 1200.74.44006 Boehringer Ingelheim Investigational Site
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Glasgow、英国
- 1200.74.44003 Boehringer Ingelheim Investigational Site
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London、英国
- 1200.74.44009 Boehringer Ingelheim Investigational Site
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Manchester、英国
- 1200.74.44012 Boehringer Ingelheim Investigational Site
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Northwood、英国
- 1200.74.44007 Boehringer Ingelheim Investigational Site
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Nottingham、英国
- 1200.74.44013 Boehringer Ingelheim Investigational Site
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Poole、英国
- 1200.74.44011 Boehringer Ingelheim Investigational Site
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Sheffield、英国
- 1200.74.44010 Boehringer Ingelheim Investigational Site
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Southampton、英国
- 1200.74.44008 Boehringer Ingelheim Investigational Site
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Sutton, Surrey、英国
- 1200.74.44004 Boehringer Ingelheim Investigational Site
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Truro、英国
- 1200.74.44002 Boehringer Ingelheim Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens
- Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.
Exclusion criteria:
- Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules or antibodies.
- Biological treatment (including Bevacizumab or any other antiangiogenic agents) during the trial is not allowed.
- Known pre-existing interstitial lung disease.
- Planned major surgical procedures during the trial period.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：书目 2992
患者每天服用一次 BIBW 2992 片剂
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Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management
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有源比较器：Cetuximab
Patients receive cetuximab intravenously once a week, every week
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Patients receive cetuximab intravenously, once a week, every week
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Objective Response
大体时间：Baseline till progression or death, whichever came first, assessed up to 23 months
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Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.
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Baseline till progression or death, whichever came first, assessed up to 23 months
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Percentage of Participants With Disease Control (DC)
大体时间：Baseline till progression or death, whichever came first, assessed up to 23 months
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Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.
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Baseline till progression or death, whichever came first, assessed up to 23 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression Free Survival (PFS)
大体时间：Baseline till progression or death, whichever came first, assessed up to 23 months
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PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier.
Median and confidence interval estimated using product-limit Kaplan-Meier method.
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Baseline till progression or death, whichever came first, assessed up to 23 months
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Overall Survival (OS) Time
大体时间：Baseline till death, assessed up to 23 months
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OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death.
Median and confidence interval estimated using product-limit Kaplan-Meier method.
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Baseline till death, assessed up to 23 months
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Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)
大体时间：day 8
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Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.
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day 8
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年6月1日
初级完成 (实际的)
2012年3月1日
研究注册日期
首次提交
2010年6月28日
首先提交符合 QC 标准的
2010年6月28日
首次发布 (估计)
2010年6月29日
研究记录更新
最后更新发布 (估计)
2014年6月26日
上次提交的符合 QC 标准的更新
2014年5月27日
最后验证
2014年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.