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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nintedanib (BIBF 1120)
Placebo
BSC
BSC
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity.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.

Sites / Locations

  • 1199.52.0108 Boehringer Ingelheim Investigational Site
  • 1199.52.0105 Boehringer Ingelheim Investigational Site
  • 1199.52.0101 Boehringer Ingelheim Investigational Site
  • 1199.52.0121 Boehringer Ingelheim Investigational Site
  • 1199.52.0123 Boehringer Ingelheim Investigational Site
  • 1199.52.0104 Boehringer Ingelheim Investigational Site
  • 1199.52.0114 Boehringer Ingelheim Investigational Site
  • 1199.52.0113 Boehringer Ingelheim Investigational Site
  • 1199.52.0125 Boehringer Ingelheim Investigational Site
  • 1199.52.0119 Boehringer Ingelheim Investigational Site
  • 1199.52.0115 Boehringer Ingelheim Investigational Site
  • 1199.52.0106 Boehringer Ingelheim Investigational Site
  • 1199.52.0102 Boehringer Ingelheim Investigational Site
  • 1199.52.0120 Boehringer Ingelheim Investigational Site
  • 1199.52.5404 Boehringer Ingelheim Investigational Site
  • 1199.52.5405 Boehringer Ingelheim Investigational Site
  • 1199.52.5401 Boehringer Ingelheim Investigational Site
  • 1199.52.5403 Boehringer Ingelheim Investigational Site
  • 1199.52.5406 Boehringer Ingelheim Investigational Site
  • 1199.52.6102 Boehringer Ingelheim Investigational Site
  • 1199.52.6103 Boehringer Ingelheim Investigational Site
  • 1199.52.6101 Boehringer Ingelheim Investigational Site
  • 1199.52.6104 Boehringer Ingelheim Investigational Site
  • 1199.52.6105 Boehringer Ingelheim Investigational Site
  • 1199.52.6106 Boehringer Ingelheim Investigational Site
  • 1199.52.4302 Boehringer Ingelheim Investigational Site
  • 1199.52.4303 Boehringer Ingelheim Investigational Site
  • 1199.52.4304 Boehringer Ingelheim Investigational Site
  • 1199.52.3208 Boehringer Ingelheim Investigational Site
  • 1199.52.3205 Boehringer Ingelheim Investigational Site
  • 1199.52.3202 Boehringer Ingelheim Investigational Site
  • 1199.52.3207 Boehringer Ingelheim Investigational Site
  • 1199.52.3204 Boehringer Ingelheim Investigational Site
  • 1199.52.3203 Boehringer Ingelheim Investigational Site
  • 1199.52.3201 Boehringer Ingelheim Investigational Site
  • 1199.52.3206 Boehringer Ingelheim Investigational Site
  • 1199.52.3521 Boehringer Ingelheim Investigational Site
  • 1199.52.1003 Boehringer Ingelheim Investigational Site
  • 1199.52.1004 Boehringer Ingelheim Investigational Site
  • 1199.52.1001 Boehringer Ingelheim Investigational Site
  • 1199.52.1002 Boehringer Ingelheim Investigational Site
  • 1199.52.4202 Boehringer Ingelheim Investigational Site
  • 1199.52.4204 Boehringer Ingelheim Investigational Site
  • 1199.52.4201 Boehringer Ingelheim Investigational Site
  • 1199.52.4502 Boehringer Ingelheim Investigational Site
  • 1199.52.4501 Boehringer Ingelheim Investigational Site
  • 1199.52.4503 Boehringer Ingelheim Investigational Site
  • 1199.52.4504 Boehringer Ingelheim Investigational Site
  • 1199.52.3304 Boehringer Ingelheim Investigational Site
  • 1199.52.3307 Boehringer Ingelheim Investigational Site
  • 1199.52.3305 Boehringer Ingelheim Investigational Site
  • 1199.52.3301 Boehringer Ingelheim Investigational Site
  • 1199.52.4906 Boehringer Ingelheim Investigational Site
  • 1199.52.4905 Boehringer Ingelheim Investigational Site
  • 1199.52.4904 Boehringer Ingelheim Investigational Site
  • 1199.52.4903 Boehringer Ingelheim Investigational Site
  • 1199.52.4901 Boehringer Ingelheim Investigational Site
  • 1199.52.8501 Boehringer Ingelheim Investigational Site
  • 1199.52.8502 Boehringer Ingelheim Investigational Site
  • 1199.52.8503 Boehringer Ingelheim Investigational Site
  • 1199.52.8504 Boehringer Ingelheim Investigational Site
  • 1199.52.9706 Boehringer Ingelheim Investigational Site
  • 1199.52.9704 Boehringer Ingelheim Investigational Site
  • 1199.52.9703 Boehringer Ingelheim Investigational Site
  • 1199.52.3901 Boehringer Ingelheim Investigational Site
  • 1199.52.3906 Boehringer Ingelheim Investigational Site
  • 1199.52.3907 Boehringer Ingelheim Investigational Site
  • 1199.52.3905 Boehringer Ingelheim Investigational Site
  • 1199.52.3903 Boehringer Ingelheim Investigational Site
  • 1199.52.3904 Boehringer Ingelheim Investigational Site
  • 1199.52.8102 Boehringer Ingelheim Investigational Site
  • 1199.52.8105 Boehringer Ingelheim Investigational Site
  • 1199.52.8101 Boehringer Ingelheim Investigational Site
  • 1199.52.8107 Boehringer Ingelheim Investigational Site
  • 1199.52.8106 Boehringer Ingelheim Investigational Site
  • 1199.52.8108 Boehringer Ingelheim Investigational Site
  • 1199.52.8115 Boehringer Ingelheim Investigational Site
  • 1199.52.8112 Boehringer Ingelheim Investigational Site
  • 1199.52.8114 Boehringer Ingelheim Investigational Site
  • 1199.52.8110 Boehringer Ingelheim Investigational Site
  • 1199.52.8116 Boehringer Ingelheim Investigational Site
  • 1199.52.8103 Boehringer Ingelheim Investigational Site
  • 1199.52.8109 Boehringer Ingelheim Investigational Site
  • 1199.52.8104 Boehringer Ingelheim Investigational Site
  • 1199.52.8113 Boehringer Ingelheim Investigational Site
  • 1199.52.8111 Boehringer Ingelheim Investigational Site
  • 1199.52.8202 Boehringer Ingelheim Investigational Site
  • 1199.52.8201 Boehringer Ingelheim Investigational Site
  • 1199.52.8203 Boehringer Ingelheim Investigational Site
  • 1199.52.8204 Boehringer Ingelheim Investigational Site
  • 1199.52.5201 Boehringer Ingelheim Investigational Site
  • 1199.52.3101 Boehringer Ingelheim Investigational Site
  • 1199.52.3103 Boehringer Ingelheim Investigational Site
  • 1199.52.3102 Boehringer Ingelheim Investigational Site
  • 1199.52.4801 Boehringer Ingelheim Investigational Site
  • 1199.52.4803 Boehringer Ingelheim Investigational Site
  • 1199.52.4804 Boehringer Ingelheim Investigational Site
  • 1199.52.3504 Boehringer Ingelheim Investigational Site
  • 1199.52.3502 Boehringer Ingelheim Investigational Site
  • 1199.52.3505 Boehringer Ingelheim Investigational Site
  • 1199.52.3501 Boehringer Ingelheim Investigational Site
  • 1199.52.3506 Boehringer Ingelheim Investigational Site
  • 1199.52.0701 Boehringer Ingelheim Investigational Site
  • 1199.52.0703 Boehringer Ingelheim Investigational Site
  • 1199.52.0702 Boehringer Ingelheim Investigational Site
  • 1199.52.0707 Boehringer Ingelheim Investigational Site
  • 1199.52.3401 Boehringer Ingelheim Investigational Site
  • 1199.52.3402 Boehringer Ingelheim Investigational Site
  • 1199.52.3406 Boehringer Ingelheim Investigational Site
  • 1199.52.3403 Boehringer Ingelheim Investigational Site
  • 1199.52.3404 Boehringer Ingelheim Investigational Site
  • 1199.52.3405 Boehringer Ingelheim Investigational Site
  • 1199.52.3407 Boehringer Ingelheim Investigational Site
  • 1199.52.4601 Boehringer Ingelheim Investigational Site
  • 1199.52.4602 Boehringer Ingelheim Investigational Site
  • 1199.52.8805 Boehringer Ingelheim Investigational Site
  • 1199.52.8801 Boehringer Ingelheim Investigational Site
  • 1199.52.8803 Boehringer Ingelheim Investigational Site
  • 1199.52.8802 Boehringer Ingelheim Investigational Site
  • 1199.52.9005 Boehringer Ingelheim Investigational Site
  • 1199.52.9001 Boehringer Ingelheim Investigational Site
  • 1199.52.9003 Boehringer Ingelheim Investigational Site
  • 1199.52.9004 Boehringer Ingelheim Investigational Site
  • 1199.52.9002 Boehringer Ingelheim Investigational Site
  • 1199.52.4401 Boehringer Ingelheim Investigational Site
  • 1199.52.4403 Boehringer Ingelheim Investigational Site
  • 1199.52.4402 Boehringer Ingelheim Investigational Site
  • 1199.52.4405 Boehringer Ingelheim Investigational Site
  • 1199.52.4404 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nintedanib (BIBF 1120) + BSC

Placebo + BSC

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) by Central Review Assessment
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.
Overall Survival (OS)
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.

Secondary Outcome Measures

Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment
Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.
Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment
Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).

Full Information

First Posted
May 26, 2014
Last Updated
June 23, 2017
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02149108
Brief Title
Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 25, 2014 (Actual)
Primary Completion Date
May 13, 2016 (Actual)
Study Completion Date
August 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
768 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nintedanib (BIBF 1120) + BSC
Arm Type
Experimental
Arm Title
Placebo + BSC
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nintedanib (BIBF 1120)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
BSC
Intervention Type
Drug
Intervention Name(s)
BSC
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) by Central Review Assessment
Description
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.
Time Frame
From randomisation until cut-off date 14JUN2016.
Title
Overall Survival (OS)
Description
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.
Time Frame
From randomisation until cut-off date 14JUN2016.
Secondary Outcome Measure Information:
Title
Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment
Description
Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.
Time Frame
From randomisation until cut-off date 14JUN2016.
Title
Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment
Description
Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).
Time Frame
From randomisation until cut-off date 14JUN2016.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
30010751
Citation
Van Cutsem E, Yoshino T, Lenz HJ, Lonardi S, Falcone A, Limon ML, Saunders M, Sobrero A, Park YS, Ferreiro R, Hong YS, Tomasek J, Taniguchi H, Ciardiello F, Stoehr J, Oum'Hamed Z, Vlassak S, Studeny M, Argiles G. Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study. Ann Oncol. 2018 Sep 1;29(9):1955-1963. doi: 10.1093/annonc/mdy241.
Results Reference
derived
PubMed Identifier
26603056
Citation
Van Cutsem E, Yoshino T, Hocke J, Oum'Hamed Z, Studeny M, Tabernero J. Rationale and Design for the LUME-Colon 1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Nintedanib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Colorectal Cancer Refractory to Standard Treatment. Clin Colorectal Cancer. 2016 Mar;15(1):91-94.e1. doi: 10.1016/j.clcc.2015.09.005. Epub 2015 Oct 9.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

Learn more about this trial

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

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