Colorectal NeoplasmsPhase 3NCT02149108

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

A Phase 3 study testing Nintedanib (BIBF 1120) and BSC in people with Colorectal Neoplasms, run by Boehringer Ingelheim at 129 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Neoplasms
What is being tested?: Nintedanib (BIBF 1120) and BSC
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 768 participants
Where: 129 sitesin 25 countries
Study dates: 25 Sep 2014to 25 Aug 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 16Show fewer

Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity.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

Who cannot join

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

Show all 11Show fewer

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.

Trial locations and contacts

129 sites in 25 countries.

Country

City, postcode or hospital

129 sites in 25 countries

Japan16 sites

1199.52.8102 Boehringer Ingelheim Investigational Site
Aichi, Nagoya
1199.52.8105 Boehringer Ingelheim Investigational Site
Chiba, Chiba
1199.52.8101 Boehringer Ingelheim Investigational Site
Chiba, Kashiwa
1199.52.8107 Boehringer Ingelheim Investigational Site
Ehime, Matsuyama
1199.52.8106 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
1199.52.8108 Boehringer Ingelheim Investigational Site
Hokkaido, Sapporo
1199.52.8115 Boehringer Ingelheim Investigational Site
Hyogo, Amagasaki
1199.52.8112 Boehringer Ingelheim Investigational Site
Hyogo, Kobe
1199.52.8114 Boehringer Ingelheim Investigational Site
Ibaraki, Tsukuba
1199.52.8110 Boehringer Ingelheim Investigational Site
Oita, Yufu
1199.52.8116 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1199.52.8103 Boehringer Ingelheim Investigational Site
Osaka, Suita
1199.52.8109 Boehringer Ingelheim Investigational Site
Saitama, Kitaadachi-gun
1199.52.8104 Boehringer Ingelheim Investigational Site
Shizuoka, Sunto-gun
1199.52.8113 Boehringer Ingelheim Investigational Site
Tokyo , Shinagawa-ku
1199.52.8111 Boehringer Ingelheim Investigational Site
Tokyo, Koto-ku

Other trials in Japan

United States14 sites

1199.52.0121 Boehringer Ingelheim Investigational Site
Arlington Heights, Illinois
1199.52.0115 Boehringer Ingelheim Investigational Site
Canton, Ohio
1199.52.0113 Boehringer Ingelheim Investigational Site
Detroit, Michigan
1199.52.0120 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1199.52.0119 Boehringer Ingelheim Investigational Site
Johnson City, New York
1199.52.0108 Boehringer Ingelheim Investigational Site
Los Angeles, California
1199.52.0102 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
1199.52.0105 Boehringer Ingelheim Investigational Site
New Haven, Connecticut
1199.52.0114 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
1199.52.0125 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1199.52.0101 Boehringer Ingelheim Investigational Site
Plainville, Connecticut
1199.52.0123 Boehringer Ingelheim Investigational Site
Sioux City, Iowa
1199.52.0106 Boehringer Ingelheim Investigational Site
Sylvania, Ohio
1199.52.0104 Boehringer Ingelheim Investigational Site
Topeka, Kansas

Other trials in United States

Belgium9 sites

1199.52.3208 Boehringer Ingelheim Investigational Site
Aalst
1199.52.3205 Boehringer Ingelheim Investigational Site
Bonheiden
1199.52.3202 Boehringer Ingelheim Investigational Site
Brussels
1199.52.3207 Boehringer Ingelheim Investigational Site
Charleroi
1199.52.3204 Boehringer Ingelheim Investigational Site
Edegem
1199.52.3203 Boehringer Ingelheim Investigational Site
Haine-Saint-Paul
1199.52.3201 Boehringer Ingelheim Investigational Site
Leuven
1199.52.3206 Boehringer Ingelheim Investigational Site
Liège
1199.52.3521 Boehringer Ingelheim Investigational Site
Luxembourg

Other trials in Belgium

Spain7 sites

1199.52.3406 Boehringer Ingelheim Investigational Site
A Coruña
1199.52.3401 Boehringer Ingelheim Investigational Site
Barcelona
1199.52.3402 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1199.52.3403 Boehringer Ingelheim Investigational Site
Madrid
1199.52.3404 Boehringer Ingelheim Investigational Site
Madrid
1199.52.3405 Boehringer Ingelheim Investigational Site
Santander
1199.52.3407 Boehringer Ingelheim Investigational Site
Seville

Other trials in Spain

Australia6 sites

1199.52.6102 Boehringer Ingelheim Investigational Site
Concord, New South Wales
1199.52.6104 Boehringer Ingelheim Investigational Site
Heidelberg, Victoria
1199.52.6105 Boehringer Ingelheim Investigational Site
Nedlands, Western Australia
1199.52.6106 Boehringer Ingelheim Investigational Site
Perth, Western Australia
1199.52.6103 Boehringer Ingelheim Investigational Site
St Leonards, New South Wales
1199.52.6101 Boehringer Ingelheim Investigational Site
Wollongong, New South Wales

Other trials in Australia

Italy6 sites

1199.52.3901 Boehringer Ingelheim Investigational Site
Genova
1199.52.3906 Boehringer Ingelheim Investigational Site
Milan
1199.52.3907 Boehringer Ingelheim Investigational Site
Naples
1199.52.3905 Boehringer Ingelheim Investigational Site
Padova
1199.52.3903 Boehringer Ingelheim Investigational Site
Pisa
1199.52.3904 Boehringer Ingelheim Investigational Site
San Giovanni Rotondo (FG)

Other trials in Italy

Argentina5 sites

1199.52.5404 Boehringer Ingelheim Investigational Site
Cdad. de Córdoba
1199.52.5405 Boehringer Ingelheim Investigational Site
Cdad. de Córdoba
1199.52.5401 Boehringer Ingelheim Investigational Site
Ciudad Autónoma de Bs As
1199.52.5403 Boehringer Ingelheim Investigational Site
Ciudad Autónoma de Bs As
1199.52.5406 Boehringer Ingelheim Investigational Site
Ciudad Autónoma de Bs As

Other trials in Argentina

Germany5 sites

1199.52.4906 Boehringer Ingelheim Investigational Site
Dresden
1199.52.4905 Boehringer Ingelheim Investigational Site
Essen
1199.52.4904 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1199.52.4903 Boehringer Ingelheim Investigational Site
Mannheim
1199.52.4901 Boehringer Ingelheim Investigational Site
Ulm

Other trials in Germany

Portugal5 sites

1199.52.3504 Boehringer Ingelheim Investigational Site
Almada
1199.52.3502 Boehringer Ingelheim Investigational Site
Coimbra
1199.52.3505 Boehringer Ingelheim Investigational Site
Loures
1199.52.3501 Boehringer Ingelheim Investigational Site
Porto
1199.52.3506 Boehringer Ingelheim Investigational Site
Porto

Other trials in Portugal

Turkey (Türkiye)5 sites

1199.52.9005 Boehringer Ingelheim Investigational Site
Adana
1199.52.9001 Boehringer Ingelheim Investigational Site
Ankara
1199.52.9003 Boehringer Ingelheim Investigational Site
Antalya
1199.52.9004 Boehringer Ingelheim Investigational Site
Istanbul
1199.52.9002 Boehringer Ingelheim Investigational Site
Izmir

Other trials in Turkey (Türkiye)

United Kingdom5 sites

1199.52.4401 Boehringer Ingelheim Investigational Site
Aberdeen
1199.52.4403 Boehringer Ingelheim Investigational Site
Manchester
1199.52.4402 Boehringer Ingelheim Investigational Site
Middlesex
1199.52.4405 Boehringer Ingelheim Investigational Site
Nottingham
1199.52.4404 Boehringer Ingelheim Investigational Site
Southampton

Other trials in United Kingdom

Canada4 sites

1199.52.1004 Boehringer Ingelheim Investigational Site
Edmonton, Ontario
1199.52.1002 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1199.52.1001 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1199.52.1003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

Denmark4 sites

1199.52.4502 Boehringer Ingelheim Investigational Site
Herning
1199.52.4501 Boehringer Ingelheim Investigational Site
København Ø
1199.52.4503 Boehringer Ingelheim Investigational Site
Næstved
1199.52.4504 Boehringer Ingelheim Investigational Site
Odense C

Other trials in Denmark

France4 sites

1199.52.3304 Boehringer Ingelheim Investigational Site
Lille
1199.52.3307 Boehringer Ingelheim Investigational Site
Lyon
1199.52.3305 Boehringer Ingelheim Investigational Site
Paris
1199.52.3301 Boehringer Ingelheim Investigational Site
Reims

Other trials in France

Hong Kong4 sites

1199.52.8501 Boehringer Ingelheim Investigational Site
Hong Kong
1199.52.8502 Boehringer Ingelheim Investigational Site
Hong Kong
1199.52.8503 Boehringer Ingelheim Investigational Site
Hong Kong
1199.52.8504 Boehringer Ingelheim Investigational Site
Hong Kong

Other trials in Hong Kong

Russia4 sites

1199.52.0701 Boehringer Ingelheim Investigational Site
Moscow
1199.52.0703 Boehringer Ingelheim Investigational Site
Moscow
1199.52.0702 Boehringer Ingelheim Investigational Site
Saint Petersburg
1199.52.0707 Boehringer Ingelheim Investigational Site
Tyumen

Other trials in Russia

South Korea4 sites

1199.52.8202 Boehringer Ingelheim Investigational Site
Goyang
1199.52.8201 Boehringer Ingelheim Investigational Site
Seoul
1199.52.8203 Boehringer Ingelheim Investigational Site
Seoul
1199.52.8204 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

Taiwan4 sites

1199.52.8805 Boehringer Ingelheim Investigational Site
Kaohsiung City
1199.52.8801 Boehringer Ingelheim Investigational Site
Taipei
1199.52.8803 Boehringer Ingelheim Investigational Site
Taipei
1199.52.8802 Boehringer Ingelheim Investigational Site
Taoyuan County

Other trials in Taiwan

Austria3 sites

1199.52.4302 Boehringer Ingelheim Investigational Site
Linz
1199.52.4303 Boehringer Ingelheim Investigational Site
Vienna
1199.52.4304 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

Czechia3 sites

1199.52.4202 Boehringer Ingelheim Investigational Site
Brno
1199.52.4204 Boehringer Ingelheim Investigational Site
Hradec Králové
1199.52.4201 Boehringer Ingelheim Investigational Site
Prague

Other trials in Czechia

Israel3 sites

1199.52.9706 Boehringer Ingelheim Investigational Site
Beersheba
1199.52.9704 Boehringer Ingelheim Investigational Site
Petah Tikva
1199.52.9703 Boehringer Ingelheim Investigational Site
Tel Aviv

Other trials in Israel

Netherlands3 sites

1199.52.3101 Boehringer Ingelheim Investigational Site
Amsterdam
1199.52.3103 Boehringer Ingelheim Investigational Site
Amsterdam
1199.52.3102 Boehringer Ingelheim Investigational Site
Utrecht

Other trials in Netherlands

Poland3 sites

1199.52.4801 Boehringer Ingelheim Investigational Site
Jelenia Góra
1199.52.4803 Boehringer Ingelheim Investigational Site
Poznan
1199.52.4804 Boehringer Ingelheim Investigational Site
Wroclaw

Other trials in Poland

Sweden2 sites

1199.52.4601 Boehringer Ingelheim Investigational Site
Stockholm
1199.52.4602 Boehringer Ingelheim Investigational Site
Uppsala

Other trials in Sweden

Mexico1 site

1199.52.5201 Boehringer Ingelheim Investigational Site
México

Other trials in Mexico

About this study

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.

Conditions: Colorectal Neoplasms
Being tested: Nintedanib (BIBF 1120), Placebo, BSC
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nintedanib (BIBF 1120)Drug
PlaceboDrug
BSCDrug
BSCDrug

Study groups in NCT02149108
Study group	Role	What they receive
Nintedanib (BIBF 1120) + BSC	Experimental	Not described Receives: Drug: Nintedanib (BIBF 1120); Drug: BSC
Placebo + BSC	Placebo comparator	Not described Receives: Drug: Placebo; Drug: BSC

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From randomisation until cut-off date 14JUN2016.
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.
Measured: From randomisation until cut-off date 14JUN2016.

Secondary outcomes (2)

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.
Measured: From randomisation until cut-off date 14JUN2016.
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).
Measured: From randomisation until cut-off date 14JUN2016.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 201425 Aug 2016

First posted29 May 2014 (estimated)
Study start25 Sep 2014
Primary completion13 May 2016
Study completion25 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 768 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02149108
Sponsor's protocol ID: 1199.52
Other IDs: 2012-000095-42
Status last verified: Jun 2017
First submitted: 26 May 2014
Last updated: 21 Jul 2017
Results posted: Yes, on ClinicalTrials.gov

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.
PubMed 30010751
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.
PubMed 26603056

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

All Colorectal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02149108
Acronym / sponsor ID: 1199.52
Conditions: Colorectal Neoplasms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 768 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 25 Sep 2014 (actual)
Primary completion: 13 May 2016 (actual)
Study completion: 25 Aug 2016 (actual)
First posted: 29 May 2014 (estimated)
Results: Posted 21 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Nintedanib (BIBF 1120) + BSC	Experimental	Drug: Nintedanib (BIBF 1120), Drug: BSC
Placebo + BSC	Placebo comparator	Drug: Placebo, Drug: BSC

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nintedanib (BIBF 1120)	Drug	Nintedanib (BIBF 1120) + BSC
Placebo	Drug	Placebo + BSC
BSC	Drug	Placebo + BSC
BSC	Drug	Nintedanib (BIBF 1120) + BSC

Primary outcome

Progression-Free Survival (PFS) by Central Review Assessment
Time frame: From randomisation until cut-off date 14JUN2016.
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)
Time frame: From randomisation until cut-off date 14JUN2016.
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.

2 secondary outcomes

Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment
Time frame: From randomisation until cut-off date 14JUN2016.
Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment
Time frame: From randomisation until cut-off date 14JUN2016.

Results and safety

Results posted to the registry on 21 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	382	2
Nintedanib	386	3

Primary outcome: Progression-Free Survival (PFS) by Central Review Assessment

Time frame: From randomisation until cut-off date 14JUN2016.. Median (95% Confidence Interval). Unit: Months

Measure	Placebo n = 382	Nintedanib n = 386
Value	1.38 (1.38 to 1.41)	1.51 (1.45 to 2.17)

Placebo vs Nintedanib: Hazard Ratio (HR): 0.58 (95% CI 0.49 to 0.69), p <0.0001, Log Rank

Population analysed: Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.

Primary outcome: Overall Survival (OS)

Time frame: From randomisation until cut-off date 14JUN2016.. Median (95% Confidence Interval). Unit: Months

Measure	Placebo n = 382	Nintedanib n = 386
Value	6.05 (5.22 to 6.97)	6.44 (5.98 to 7.10)

Placebo vs Nintedanib: Hazard Ratio (HR): 1.01 (95% CI 0.86 to 1.19), p = 0.8659, Log Rank

Population analysed: Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 28 days after last drug administration, up to 22.7 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	133 of 381 (34.9%)	309 of 381 (81.1%)	Not reported
Nintedanib	149 of 384 (38.8%)	351 of 384 (91.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30010751Van 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.
Derived from this study: PubMed 26603056Van 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.

Related trials for Colorectal Neoplasms

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

129 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nintedanib (BIBF 1120) and BSC in people with Colorectal Neoplasms, run by Boehringer Ingelheim at 129 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in Japan, United States, Belgium, Spain, Australia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) by Central Review Assessment (time frame: From randomisation until cut-off date 14JUN2016.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02149108, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.