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

June 23, 2017 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

768

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nintedanib (BIBF 1120) + BSC
Drug: Nintedanib (BIBF 1120)
Drug: BSC
Placebo Comparator: Placebo + BSC
Drug: Placebo
Drug: BSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) by Central Review Assessment
Time Frame: 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)
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2014

Primary Completion (Actual)

May 13, 2016

Study Completion (Actual)

August 25, 2016

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 26, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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