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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 24 January 2022
Main ID:  EUCTR2012-000095-42-LU
Date of registration: 26/06/2014
Prospective Registration: Yes
Primary sponsor: SCS Boehringer Ingelheim Comm.V
Public title: Nintedanib (BIBF 1120) vs placebo in refractory colorectal cancer
Scientific title: A double-blind, randomised, placebo controlled Phase III study of nintedanib plus best supportive care (BSC) versus placebo plus BSC in patients with colorectal cancer refractory to standard therapies. - LUME-Colon 1
Date of first enrolment: 08/10/2014
Target sample size: 800
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000095-42
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Austria Belgium Canada Czech Republic Denmark France
Germany Hong Kong Israel Italy Japan Korea, Republic of Luxembourg Mexico
Netherlands Poland Portugal Russian Federation Singapore Spain Sweden Taiwan
Turkey United Kingdom United States
Contacts
Name: QRPE PSC CT Information Disclosure   
Address:  Binger Strasse 173 55216 Ingelheim am Rhein Germany
Telephone: +18002430127
Email: clintriage.rdg@boehringer-ingelheim.com
Affiliation:  Boehringer Ingelheim Pharma GmbH & Co. KG
Name: QRPE PSC CT Information Disclosure   
Address:  Binger Strasse 173 55216 Ingelheim am Rhein Germany
Telephone: +18002430127
Email: clintriage.rdg@boehringer-ingelheim.com
Affiliation:  Boehringer Ingelheim Pharma GmbH & Co. KG
Key inclusion & exclusion 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 oxalipatin 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
- - previous treatment with regorafenib is allowed
- - Life expectancy of at least 12 weeks
- - Hepatic function: aspartate aminotransferase (AST)/ Alanine Amino Tranferase (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 prothrombin Time (PTT) = 2xULN

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 264

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Cancer [C04]
Patients with metastatic colorectal cancer refractory to standards therapies
MedDRA version: 17.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Intervention(s)

Product Name: Nintedanib 100 mg soft capsules
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Product Name: Nintedanib 150 mg soft capsules
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)
Primary end point(s): 1: Primary endpoint is progression free survival (PFS)
Main Objective: The objective of this Phase III study is to evaluate the efficacy and safety of nintedanib in patients with mCRC after failure of previous treatment with standard chemotherapy and biological agents.
Secondary Objective: Secondary objectives are Objective tumour response, disease control, quality of life and safety.
Timepoint(s) of evaluation of this end point: 1: 22 months
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: 1: 22 months

2: 22 months

3: 22 months
Secondary end point(s): 1: Key secondary endpoint is Overall survival (OS)

2: Objective tumour response

3: Disease control
Secondary ID(s)
1199.52
Source(s) of Monetary Support
SCS Boehringer Ingelheim Comm.V
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 28/07/2014
Contact:
Results
Results available: Yes
Date Posted: 06/08/2017
Date Completed: 15/09/2016
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-000095-42/results
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