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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* Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity.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
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United States of America
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California
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Connecticut
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Louisiana
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Michigan
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Nebraska
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Tennessee
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Argentina
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Cdad. de Córdoba
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Ciudad Autónoma de Bs As
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Linz
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Charleroi
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Edegem
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Leuven
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Liège
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Hradec Kralove
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Prague
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Herning
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København Ø
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Næstved
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Odense C
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France
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Lille cedex
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Lyon cedex 8
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Paris cedex 15
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Dresden
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Essen
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Freiburg
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Ulm
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Hyogo, Kobe
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Ibaraki, Tsukuba
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Saitama, Kitaadachi-gun
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Shizuoka, Sunto-gun
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Tokyo , Shinagawa-ku
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Tokyo, Koto-ku
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Korea, Republic of
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Goyang
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Loures
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Tyumen
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Barcelona
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L'Hospitalet de Llobregat
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La Coruña
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Madrid
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Stockholm
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT02149108
Trial related presentations / publications
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.
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02149108