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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02149108




Registration number
NCT02149108
Ethics application status
Date submitted
26/05/2014
Date registered
29/05/2014
Date last updated
21/07/2017

Titles & IDs
Public title
Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)
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 Metastatic Colorectal Cancer Refractory to Standard Therapies.
Secondary ID [1] 0 0
2012-000095-42
Secondary ID [2] 0 0
1199.52
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Nintedanib (BIBF 1120) + BSC -

Placebo comparator: Placebo + BSC -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) by Central Review Assessment
Timepoint [1] 0 0
From randomisation until cut-off date 14JUN2016.
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomisation until cut-off date 14JUN2016.
Secondary outcome [1] 0 0
Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment
Timepoint [1] 0 0
From randomisation until cut-off date 14JUN2016.
Secondary outcome [2] 0 0
Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment
Timepoint [2] 0 0
From randomisation until cut-off date 14JUN2016.

Eligibility
Key inclusion 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* Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity.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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/08/2016
Sample size
Target
Accrual to date
Final
768
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
1199.52.6102 Boehringer Ingelheim Investigational Site - Concord
Recruitment hospital [2] 0 0
1199.52.6103 Boehringer Ingelheim Investigational Site - St Leonards
Recruitment hospital [3] 0 0
1199.52.6101 Boehringer Ingelheim Investigational Site - Wollongong
Recruitment hospital [4] 0 0
1199.52.6104 Boehringer Ingelheim Investigational Site - Heidelberg
Recruitment hospital [5] 0 0
1199.52.6105 Boehringer Ingelheim Investigational Site - Nedlands
Recruitment hospital [6] 0 0
1199.52.6106 Boehringer Ingelheim Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- St Leonards
Recruitment postcode(s) [3] 0 0
- Wollongong
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Nedlands
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Connecticut
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Illinois
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Michigan
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United States of America
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Nebraska
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New York
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Ohio
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United States of America
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Tennessee
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United States of America
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Texas
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Argentina
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Cdad. de Córdoba
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Argentina
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Ciudad Autónoma de Bs As
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Austria
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Linz
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Austria
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Wien
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Belgium
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Aalst
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Bonheiden
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Haine-Saint-Paul
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Belgium
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Leuven
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Liège
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Luxembourg
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British Columbia
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Ontario
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Quebec
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Prague
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Denmark
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Herning
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Denmark
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København Ø
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Denmark
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Næstved
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Denmark
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Odense C
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France
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Lille cedex
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France
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Lyon cedex 8
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France
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Paris cedex 15
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France
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Reims Cedex
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Germany
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Dresden
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Germany
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Essen
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Germany
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Freiburg
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Mannheim
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Germany
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Ulm
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Hong Kong
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Hong Kong
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Beer Sheva
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Israel
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Petach Tikva
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Pisa
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San Giovanni Rotondo (FG)
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Aichi, Nagoya
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Chiba, Chiba
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Chiba, Kashiwa
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Ehime, Matsuyama
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Fukuoka, Fukuoka
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Hokkaido, Sapporo
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Hyogo, Amagasaki
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Hyogo, Kobe
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Ibaraki, Tsukuba
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Oita, Yufu
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Osaka, Osaka
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Osaka, Suita
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Saitama, Kitaadachi-gun
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Shizuoka, Sunto-gun
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Japan
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Tokyo , Shinagawa-ku
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Japan
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Tokyo, Koto-ku
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Korea, Republic of
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Goyang
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Korea, Republic of
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Seoul
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Mexico
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Netherlands
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Amsterdam
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Utrecht
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Jelenia Gora
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Poznan
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Coimbra
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Loures
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Tyumen
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Barcelona
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Spain
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L'Hospitalet de Llobregat
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La Coruña
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Madrid
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Santander
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Sevilla
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Stockholm
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Sweden
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Uppsala
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Taipei
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Adana
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Ankara
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Istanbul
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Izmir
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Aberdeen
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Manchester
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Middlesex
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Nottingham
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United Kingdom
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02149108