Main
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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:
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EUCTR |
Last refreshed on:
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24 July 2017 |
Main ID: |
EUCTR2012-000095-42-SE |
Date of registration:
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11/08/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Nintedanib (BIBF 1120) vs placebo in refractory colorectal cancer
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Scientific title:
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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:
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28/08/2014 |
Target sample size:
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800 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000095-42 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Canada
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Czech Republic
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Denmark
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France
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Germany
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Hong Kong
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Israel
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Italy
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Japan
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Korea, Republic of
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Luxembourg
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Mexico
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Netherlands
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Poland
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Portugal
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Russian Federation
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Singapore
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Spain
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Sweden
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Taiwan
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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QRPE PSC CT Information Disclosure
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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+18002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim Pharma GmbH & Co. KG |
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Name:
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QRPE PSC CT Information Disclosure
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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+18002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim Pharma GmbH & Co. KG |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Patients with colorectal cancer refractory to standards therapies MedDRA version: 17.0
Level: LLT
Classification code 10052362
Term: Metastatic colorectal cancer
System Organ Class: 100000004864
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Intervention(s)
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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
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1: 22 months
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Primary end point(s): Co-primary endpoints: progression-free survival (PFS) by central review assessment and overall survival (OS)
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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.
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Secondary Objective: Secondary objectives are Objective tumour response, disease control, quality of life and safety.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1: 22 months
2: 22 months
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Secondary end point(s): 1: Objective tumour response
2: Disease control
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Secondary ID(s)
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2012-000095-42-LU
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1199.52
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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