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Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)

2017年6月23日 更新者：Boehringer Ingelheim

A Double-blind, Randomised, Placebo Controlled Phase III Study of Nintedanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies.

The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

768

阶段

  • 第三阶段

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

  • 丹麦
      • Herning、丹麦
        • 1199.52.4502 Boehringer Ingelheim Investigational Site
      • København Ø、丹麦
        • 1199.52.4501 Boehringer Ingelheim Investigational Site
      • Næstved、丹麦
        • 1199.52.4503 Boehringer Ingelheim Investigational Site
      • Odense C、丹麦
        • 1199.52.4504 Boehringer Ingelheim Investigational Site
  • 以色列
      • Beer Sheva、以色列
        • 1199.52.9706 Boehringer Ingelheim Investigational Site
      • Petach Tikva、以色列
        • 1199.52.9704 Boehringer Ingelheim Investigational Site
      • Tel Aviv、以色列
        • 1199.52.9703 Boehringer Ingelheim Investigational Site
  • 俄罗斯联邦
      • Moscow、俄罗斯联邦
        • 1199.52.0701 Boehringer Ingelheim Investigational Site
      • Moscow、俄罗斯联邦
        • 1199.52.0703 Boehringer Ingelheim Investigational Site
      • St. Petersburg、俄罗斯联邦
        • 1199.52.0702 Boehringer Ingelheim Investigational Site
      • Tyumen、俄罗斯联邦
        • 1199.52.0707 Boehringer Ingelheim Investigational Site
  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • 1199.52.1003 Boehringer Ingelheim Investigational Site
    • Ontario
      • Edmonton、Ontario、加拿大
        • 1199.52.1004 Boehringer Ingelheim Investigational Site
      • Toronto、Ontario、加拿大
        • 1199.52.1001 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal、Quebec、加拿大
        • 1199.52.1002 Boehringer Ingelheim Investigational Site
  • 台湾
      • Kaohsiung、台湾
        • 1199.52.8805 Boehringer Ingelheim Investigational Site
      • Taipei、台湾
        • 1199.52.8801 Boehringer Ingelheim Investigational Site
      • Taipei、台湾
        • 1199.52.8803 Boehringer Ingelheim Investigational Site
      • Taoyuan County、台湾
        • 1199.52.8802 Boehringer Ingelheim Investigational Site
  • 墨西哥
      • Mexico、墨西哥
        • 1199.52.5201 Boehringer Ingelheim Investigational Site
  • 大韩民国
      • Goyang、大韩民国
        • 1199.52.8202 Boehringer Ingelheim Investigational Site
      • Seoul、大韩民国
        • 1199.52.8201 Boehringer Ingelheim Investigational Site
      • Seoul、大韩民国
        • 1199.52.8203 Boehringer Ingelheim Investigational Site
      • Seoul、大韩民国
        • 1199.52.8204 Boehringer Ingelheim Investigational Site
  • 奥地利
      • Linz、奥地利
        • 1199.52.4302 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 1199.52.4303 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 1199.52.4304 Boehringer Ingelheim Investigational Site
  • 德国
      • Dresden、德国
        • 1199.52.4906 Boehringer Ingelheim Investigational Site
      • Essen、德国
        • 1199.52.4905 Boehringer Ingelheim Investigational Site
      • Freiburg、德国
        • 1199.52.4904 Boehringer Ingelheim Investigational Site
      • Mannheim、德国
        • 1199.52.4903 Boehringer Ingelheim Investigational Site
      • Ulm、德国
        • 1199.52.4901 Boehringer Ingelheim Investigational Site
  • 意大利
      • Genova、意大利
        • 1199.52.3901 Boehringer Ingelheim Investigational Site
      • Milano、意大利
        • 1199.52.3906 Boehringer Ingelheim Investigational Site
      • Napoli、意大利
        • 1199.52.3907 Boehringer Ingelheim Investigational Site
      • Padova、意大利
        • 1199.52.3905 Boehringer Ingelheim Investigational Site
      • Pisa、意大利
        • 1199.52.3903 Boehringer Ingelheim Investigational Site
      • San Giovanni Rotondo (FG)、意大利
        • 1199.52.3904 Boehringer Ingelheim Investigational Site
  • 捷克语
      • Brno、捷克语
        • 1199.52.4202 Boehringer Ingelheim Investigational Site
      • Hradec Kralove、捷克语
        • 1199.52.4204 Boehringer Ingelheim Investigational Site
      • Prague、捷克语
        • 1199.52.4201 Boehringer Ingelheim Investigational Site
  • 日本
      • Aichi, Nagoya、日本
        • 1199.52.8102 Boehringer Ingelheim Investigational Site
      • Chiba, Chiba、日本
        • 1199.52.8105 Boehringer Ingelheim Investigational Site
      • Chiba, Kashiwa、日本
        • 1199.52.8101 Boehringer Ingelheim Investigational Site
      • Ehime, Matsuyama、日本
        • 1199.52.8107 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka、日本
        • 1199.52.8106 Boehringer Ingelheim Investigational Site
      • Hokkaido, Sapporo、日本
        • 1199.52.8108 Boehringer Ingelheim Investigational Site
      • Hyogo, Amagasaki、日本
        • 1199.52.8115 Boehringer Ingelheim Investigational Site
      • Hyogo, Kobe、日本
        • 1199.52.8112 Boehringer Ingelheim Investigational Site
      • Ibaraki, Tsukuba、日本
        • 1199.52.8114 Boehringer Ingelheim Investigational Site
      • Oita, Yufu、日本
        • 1199.52.8110 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka、日本
        • 1199.52.8116 Boehringer Ingelheim Investigational Site
      • Osaka, Suita、日本
        • 1199.52.8103 Boehringer Ingelheim Investigational Site
      • Saitama, Kitaadachi-gun、日本
        • 1199.52.8109 Boehringer Ingelheim Investigational Site
      • Shizuoka, Sunto-gun、日本
        • 1199.52.8104 Boehringer Ingelheim Investigational Site
      • Tokyo , Shinagawa-ku、日本
        • 1199.52.8113 Boehringer Ingelheim Investigational Site
      • Tokyo, Koto-ku、日本
        • 1199.52.8111 Boehringer Ingelheim Investigational Site
  • 比利时
      • Aalst、比利时
        • 1199.52.3208 Boehringer Ingelheim Investigational Site
      • Bonheiden、比利时
        • 1199.52.3205 Boehringer Ingelheim Investigational Site
      • Bruxelles、比利时
        • 1199.52.3202 Boehringer Ingelheim Investigational Site
      • Charleroi、比利时
        • 1199.52.3207 Boehringer Ingelheim Investigational Site
      • Edegem、比利时
        • 1199.52.3204 Boehringer Ingelheim Investigational Site
      • Haine-Saint-Paul、比利时
        • 1199.52.3203 Boehringer Ingelheim Investigational Site
      • Leuven、比利时
        • 1199.52.3201 Boehringer Ingelheim Investigational Site
      • Liège、比利时
        • 1199.52.3206 Boehringer Ingelheim Investigational Site
      • Luxembourg、比利时
        • 1199.52.3521 Boehringer Ingelheim Investigational Site
  • 法国
      • Lille cedex、法国
        • 1199.52.3304 Boehringer Ingelheim Investigational Site
      • Lyon cedex 8、法国
        • 1199.52.3307 Boehringer Ingelheim Investigational Site
      • Paris cedex 15、法国
        • 1199.52.3305 Boehringer Ingelheim Investigational Site
      • Reims Cedex、法国
        • 1199.52.3301 Boehringer Ingelheim Investigational Site
  • 波兰
      • Jelenia Gora、波兰
        • 1199.52.4801 Boehringer Ingelheim Investigational Site
      • Poznan、波兰
        • 1199.52.4803 Boehringer Ingelheim Investigational Site
      • Wroclaw、波兰
        • 1199.52.4804 Boehringer Ingelheim Investigational Site
  • 澳大利亚
    • New South Wales
      • Concord、New South Wales、澳大利亚
        • 1199.52.6102 Boehringer Ingelheim Investigational Site
      • St Leonards、New South Wales、澳大利亚
        • 1199.52.6103 Boehringer Ingelheim Investigational Site
      • Wollongong、New South Wales、澳大利亚
        • 1199.52.6101 Boehringer Ingelheim Investigational Site
    • Victoria
      • Heidelberg、Victoria、澳大利亚
        • 1199.52.6104 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Nedlands、Western Australia、澳大利亚
        • 1199.52.6105 Boehringer Ingelheim Investigational Site
      • Perth、Western Australia、澳大利亚
        • 1199.52.6106 Boehringer Ingelheim Investigational Site
  • 火鸡
      • Adana、火鸡
        • 1199.52.9005 Boehringer Ingelheim Investigational Site
      • Ankara、火鸡
        • 1199.52.9001 Boehringer Ingelheim Investigational Site
      • Antalya、火鸡
        • 1199.52.9003 Boehringer Ingelheim Investigational Site
      • Istanbul、火鸡
        • 1199.52.9004 Boehringer Ingelheim Investigational Site
      • Izmir、火鸡
        • 1199.52.9002 Boehringer Ingelheim Investigational Site
  • 瑞典
      • Stockholm、瑞典
        • 1199.52.4601 Boehringer Ingelheim Investigational Site
      • Uppsala、瑞典
        • 1199.52.4602 Boehringer Ingelheim Investigational Site
  • 美国
    • California
      • Los Angeles、California、美国
        • 1199.52.0108 Boehringer Ingelheim Investigational Site
    • Connecticut
      • New Haven、Connecticut、美国
        • 1199.52.0105 Boehringer Ingelheim Investigational Site
      • Plainville、Connecticut、美国
        • 1199.52.0101 Boehringer Ingelheim Investigational Site
    • Illinois
      • Arlington Heights、Illinois、美国
        • 1199.52.0121 Boehringer Ingelheim Investigational Site
    • Iowa
      • Sioux City、Iowa、美国
        • 1199.52.0123 Boehringer Ingelheim Investigational Site
    • Kansas
      • Topeka、Kansas、美国
        • 1199.52.0104 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans、Louisiana、美国
        • 1199.52.0114 Boehringer Ingelheim Investigational Site
    • Michigan
      • Detroit、Michigan、美国
        • 1199.52.0113 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha、Nebraska、美国
        • 1199.52.0125 Boehringer Ingelheim Investigational Site
    • New York
      • Johnson City、New York、美国
        • 1199.52.0119 Boehringer Ingelheim Investigational Site
    • Ohio
      • Canton、Ohio、美国
        • 1199.52.0115 Boehringer Ingelheim Investigational Site
      • Sylvania、Ohio、美国
        • 1199.52.0106 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Nashville、Tennessee、美国
        • 1199.52.0102 Boehringer Ingelheim Investigational Site
    • Texas
      • Fort Worth、Texas、美国
        • 1199.52.0120 Boehringer Ingelheim Investigational Site
  • 英国
      • Aberdeen、英国
        • 1199.52.4401 Boehringer Ingelheim Investigational Site
      • Manchester、英国
        • 1199.52.4403 Boehringer Ingelheim Investigational Site
      • Middlesex、英国
        • 1199.52.4402 Boehringer Ingelheim Investigational Site
      • Nottingham、英国
        • 1199.52.4405 Boehringer Ingelheim Investigational Site
      • Southampton、英国
        • 1199.52.4404 Boehringer Ingelheim Investigational Site
  • 荷兰
      • Amsterdam、荷兰
        • 1199.52.3101 Boehringer Ingelheim Investigational Site
      • Amsterdam、荷兰
        • 1199.52.3103 Boehringer Ingelheim Investigational Site
      • Utrecht、荷兰
        • 1199.52.3102 Boehringer Ingelheim Investigational Site
  • 葡萄牙
      • Almada、葡萄牙
        • 1199.52.3504 Boehringer Ingelheim Investigational Site
      • Coimbra、葡萄牙
        • 1199.52.3502 Boehringer Ingelheim Investigational Site
      • Loures、葡萄牙
        • 1199.52.3505 Boehringer Ingelheim Investigational Site
      • Porto、葡萄牙
        • 1199.52.3501 Boehringer Ingelheim Investigational Site
      • Porto、葡萄牙
        • 1199.52.3506 Boehringer Ingelheim Investigational Site
  • 西班牙
      • Barcelona、西班牙
        • 1199.52.3401 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat、西班牙
        • 1199.52.3402 Boehringer Ingelheim Investigational Site
      • La Coruña、西班牙
        • 1199.52.3406 Boehringer Ingelheim Investigational Site
      • Madrid、西班牙
        • 1199.52.3403 Boehringer Ingelheim Investigational Site
      • Madrid、西班牙
        • 1199.52.3404 Boehringer Ingelheim Investigational Site
      • Santander、西班牙
        • 1199.52.3405 Boehringer Ingelheim Investigational Site
      • Sevilla、西班牙
        • 1199.52.3407 Boehringer Ingelheim Investigational Site
  • 阿根廷
      • Cdad. de Córdoba、阿根廷
        • 1199.52.5404 Boehringer Ingelheim Investigational Site
      • Cdad. de Córdoba、阿根廷
        • 1199.52.5405 Boehringer Ingelheim Investigational Site
      • Ciudad Autónoma de Bs As、阿根廷
        • 1199.52.5401 Boehringer Ingelheim Investigational Site
      • Ciudad Autónoma de Bs As、阿根廷
        • 1199.52.5403 Boehringer Ingelheim Investigational Site
      • Ciudad Autónoma de Bs As、阿根廷
        • 1199.52.5406 Boehringer Ingelheim Investigational Site
  • 香港
      • Hong Kong、香港
        • 1199.52.8501 Boehringer Ingelheim Investigational Site
      • Hong Kong、香港
        • 1199.52.8502 Boehringer Ingelheim Investigational Site
      • Hong Kong、香港
        • 1199.52.8503 Boehringer Ingelheim Investigational Site
      • Hong Kong、香港
        • 1199.52.8504 Boehringer Ingelheim Investigational Site

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:

  • Age >= 18 years
  • Signed informed consent
  • Histologically or cytologically confirmed colorectal adenocarcinoma
  • Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status = 1
  • At least one measurable lesion according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
  • Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. Previous standard treatment must include all of the following:
  • - fluoropyrimidine
  • - oxaliplatin: Patients treated with oxaliplatin in adjuvant setting should have progressed within 6 months of completion of adjuvant therapy or they must have been treated with oxaliplatin for metastatic disease
  • - irinotecan
  • - bevacizumab or aflibercept
  • - cetuximab or panitumumab for patients with K-Ras wt or Ras wt tumours
  • - The remaining standard available therapy as recommended by investigator is best supportive care (note: previous treatment with regorafenib and TAS 102 are allowed and these agents should be administered before study if available to patient according to local standards)
  • - Life expectancy of at least 12 weeks
  • - Hepatic function: aspartate aminotransferase (AST)/ Alanine Amino Transferase (ALT) = 1.5 X Upper Limit of Normal (ULN) and bilirubin = ULN for patients without liver metastases. AST/ALT = 2.5 X ULN and bilirubin = ULN for patients with liver metastases. Patients with Gilbert syndrome and bilirubin < 2 X ULN and normal AST/ALT are eligible
  • Coagulation parameters: International normalised ratio (INR) < 2 and partial prothrombin Time (PTT) = 2xULN

Exclusion criteria:

  • Previous treatment with nintedanib
  • toxicity attributed to previous anticancer therapy that did not resolve to Common Terminology Criteria for Adverse Events (CTCAE) grade =1
  • History of other malignancies in the last 5 years, in particular those that could interfere with interpretation of results.
  • Serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug,
  • Significant cardiovascular diseases
  • History of severe haemorrhagic or thromboembolic event in the past 12 months
  • Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic INR monitoring
  • Gastrointestinal disorders or abnormalities that would interfere with absorption of study drug
  • Patient with brain metastases that are symptomatic and/or require therapy.
  • Patients of childbearing potential who are sexually active and unwilling to use a highly effective method of contraception
  • Pregnancy or breast-feeding.

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
实验性的：Nintedanib (BIBF 1120) + BSC
药品：Nintedanib (BIBF 1120)
药品：平衡计分卡
安慰剂比较：Placebo + BSC
药品：安慰剂
药品：平衡计分卡

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
Progression-Free Survival (PFS) by Central Review Assessment
大体时间：From randomisation until cut-off date 14JUN2016.

PFS by central review assessment was defined as the time from the date of randomisation to the date of disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or death from any cause, whichever occurred first.

Median, 95% Confidence Interval were calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
From randomisation until cut-off date 14JUN2016.
Overall Survival (OS)
大体时间：From randomisation until cut-off date 14JUN2016.

OS was defined as the time from randomisation to the time of death from any cause.

Median, 95% Confidence Interval were calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
From randomisation until cut-off date 14JUN2016.

次要结果测量

结果测量
措施说明
大体时间
Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment
大体时间：From randomisation until cut-off date 14JUN2016.
Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.
From randomisation until cut-off date 14JUN2016.
Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment
大体时间：From randomisation until cut-off date 14JUN2016.
Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).
From randomisation until cut-off date 14JUN2016.

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。

赞助

Boehringer Ingelheim

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。

一般刊物

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 (实际的)

2014年9月25日

初级完成 (实际的)

2016年5月13日

研究完成 (实际的)

2016年8月25日

研究注册日期

首次提交

2014年5月26日

首先提交符合 QC 标准的

2014年5月26日

首次发布 (估计)

2014年5月29日

研究记录更新

最后更新发布 (实际的)

2017年7月21日

上次提交的符合 QC 标准的更新

2017年6月23日

最后验证

2017年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1199.52
  • 2012-000095-42 (EudraCT编号：EudraCT)

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.

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