A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
2016年5月13日 更新者：Hoffmann-La Roche
A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma
This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy.
It will also assess the efficacy and safety of Tarceva in this patient population.
Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily.
Tumor tissue will be used for biomarker analysis.
The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
研究概览
研究类型
介入性
注册 (实际的)
207
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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Kiev、乌克兰、36022
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Irkutsk、俄罗斯联邦、664035
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Kazan、俄罗斯联邦、420111
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Krasnodar、俄罗斯联邦、350040
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Moscow、俄罗斯联邦、115478
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St Petersburg、俄罗斯联邦、195067
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St Petersburg、俄罗斯联邦、198255
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Gabrovo、保加利亚、5300
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Pleven、保加利亚、5800
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Plovdiv、保加利亚、4004
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Sofia、保加利亚、1756
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Sofia、保加利亚、1233
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Sofia、保加利亚、1431
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Vratsa、保加利亚、3000
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Vratza、保加利亚、3000
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Zagreb、克罗地亚、10000
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Bangalore、印度、560029
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Chennai、印度、600035
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Jaipur、印度、302004
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Kochi、印度、682304
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Kolkata、印度、700053
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Ludhiana、印度、141 001
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Mumbai、印度、400012
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New Delhi、印度、110076
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Pune、印度、411 001
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Vellore、印度、632004
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Monterrey、墨西哥、64020
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BA
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Salvador, Bahia、BA、巴西、40170-380
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MG
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Belo Horizonte、MG、巴西、30110-0090
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PR
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Curitiba、PR、巴西、81520-060
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RS
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Ijui、RS、巴西、98700-000
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Porto Alegre、RS、巴西、90430-090
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Porto Alegre、RS、巴西、91350-200
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Porto Alegre、RS、巴西、90020-090
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SP
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Jau、SP、巴西、17210-080
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Sao Paulo、SP、巴西、01246-000
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Sao Paulo、SP、巴西、05652-000
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Bochum、德国、44791
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Dresden、德国、01307
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Esslingen、德国、73730
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Greifswald、德国、17489
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Hamburg、德国、20148
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Köln、德国、50937
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Saarbruecken、德国、66113
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Ulm、德国、89081
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Emilia-Romagna
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Bologna、Emilia-Romagna、意大利、40138
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Friuli-Venezia Giulia
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Udine、Friuli-Venezia Giulia、意大利、33100
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Riga、拉脱维亚、LV-1002
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Ljubljana、斯洛文尼亚、1000
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Singapore、新加坡、169610
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New South Wales
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Kogarah、New South Wales、澳大利亚、2217
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St. Leonards、New South Wales、澳大利亚、2065
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Sydney、New South Wales、澳大利亚、2076
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Victoria
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Box Hill、Victoria、澳大利亚、3128
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Arequipa、秘鲁、04001
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Chiclayo、秘鲁、CIX
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San Isidro、秘鲁、L27 Lima
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Kaunas、立陶宛、50009
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Vilnius、立陶宛、08660
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Vilnius、立陶宛、08661
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Bucharest、罗马尼亚
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Cluj Napoca、罗马尼亚、400015
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Craiova (Dolj county)、罗马尼亚、200535
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London、英国、SE1 9RT
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London、英国、N18 1QX
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London、英国、SW3 6JJ
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London、英国、EC1A 7BE
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Sutton、英国、SM2 5PT
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Hong Kong、香港
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Hong Kong、香港、852
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Kuala Lumpur、马来西亚、59100
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Penang、马来西亚、11200
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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:
- adult patients, >=18 years of age;
- histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
- measurable disease according to RECIST;
- failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
- ECOG performance status of 0-2.
Exclusion Criteria:
- local or locally advanced-resectable pancreatic cancer;
- any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
- major surgery within 2 weeks prior to randomization.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Erlotinib
Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
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Participants received erlotinib 150 mg tablet orally once daily.
其他名称：
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安慰剂比较：Placebo
Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression, unacceptable toxicity, withdrawal, or death.
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Participants received placebo matching to erlotinib 150 mg tablet orally once daily.
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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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Progression-Free Survival
大体时间：From the time of randomization until progression of disease or death (up to 30 months)
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Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first.
Participants without event were censored at the date of last tumor assessment where non-progression was documented.
Analysis was performed using Kaplan-Meier method.
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From the time of randomization until progression of disease or death (up to 30 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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Percentage of Participants With Best Overall Response Rate
大体时间：From the time of randomization until progression of disease or death (up to 30 months)
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Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response).
CR was defined as the disappearance of all target lesions.
PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
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From the time of randomization until progression of disease or death (up to 30 months)
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Percentage of Participants With Disease Control Rate (DCR)
大体时间：Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)
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Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria.
Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization.
Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
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Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)
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Overall Survival
大体时间：From the time of randomization until or death (up to 30 months)
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Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.
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From the time of randomization until or death (up to 30 months)
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Number of Participants With Adverse Events (AEs)
大体时间：Up to 28 days after discontinuation of study drug (up to 30 months)
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An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment.
An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
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Up to 28 days after discontinuation of study drug (up to 30 months)
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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。
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
2008年6月1日
初级完成 (实际的)
2010年12月1日
研究完成 (实际的)
2015年3月1日
研究注册日期
首次提交
2008年4月30日
首先提交符合 QC 标准的
2008年5月7日
首次发布 (估计)
2008年5月8日
研究记录更新
最后更新发布 (估计)
2016年6月17日
上次提交的符合 QC 标准的更新
2016年5月13日
最后验证
2016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.