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

NCT02149108 | Completed Phase 3 Results

• 2 other identifiers: 1199.522012-000095-42
• Study Type: interventional
• Target: 768
• Locations: 24 countries
• Sites: 126

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From randomisation until cut-off date 14JUN2016.

Secondary Outcomes (2)

• Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment

  From randomisation until cut-off date 14JUN2016.

• Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment

  From randomisation until cut-off date 14JUN2016.

Study Arms (2)

Nintedanib (BIBF 1120) + BSC

EXPERIMENTAL

Drug: Nintedanib (BIBF 1120); Drug: BSC

Placebo + BSC

PLACEBO COMPARATOR

Drug: Placebo; Drug: BSC

Interventions

Nintedanib (BIBF 1120) DRUG

Nintedanib (BIBF 1120) + BSC

Placebo DRUG

Placebo + BSC

BSC DRUG

Placebo + BSC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (129)

1199.52.0108 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1199.52.0105 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

Location

1199.52.0101 Boehringer Ingelheim Investigational Site

Plainville, Connecticut, United States

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1199.52.0121 Boehringer Ingelheim Investigational Site

Arlington Heights, Illinois, United States

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1199.52.0123 Boehringer Ingelheim Investigational Site

Sioux City, Iowa, United States

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1199.52.0104 Boehringer Ingelheim Investigational Site

Topeka, Kansas, United States

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1199.52.0114 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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1199.52.0113 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

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1199.52.0125 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

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1199.52.0119 Boehringer Ingelheim Investigational Site

Johnson City, New York, United States

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1199.52.0115 Boehringer Ingelheim Investigational Site

Canton, Ohio, United States

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1199.52.0106 Boehringer Ingelheim Investigational Site

Sylvania, Ohio, United States

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1199.52.0102 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

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1199.52.0120 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

1199.52.5404 Boehringer Ingelheim Investigational Site

Cdad. de Córdoba, Argentina

Location

1199.52.5405 Boehringer Ingelheim Investigational Site

Cdad. de Córdoba, Argentina

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1199.52.5401 Boehringer Ingelheim Investigational Site

Ciudad Autónoma de Bs As, Argentina

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1199.52.5403 Boehringer Ingelheim Investigational Site

Ciudad Autónoma de Bs As, Argentina

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1199.52.5406 Boehringer Ingelheim Investigational Site

Ciudad Autónoma de Bs As, Argentina

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1199.52.6102 Boehringer Ingelheim Investigational Site

Concord, New South Wales, Australia

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1199.52.6103 Boehringer Ingelheim Investigational Site

St Leonards, New South Wales, Australia

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1199.52.6101 Boehringer Ingelheim Investigational Site

Wollongong, New South Wales, Australia

Location

1199.52.6104 Boehringer Ingelheim Investigational Site

Heidelberg, Victoria, Australia

Location

1199.52.6105 Boehringer Ingelheim Investigational Site

Nedlands, Western Australia, Australia

Location

1199.52.6106 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

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1199.52.4302 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1199.52.4303 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1199.52.4304 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1199.52.3208 Boehringer Ingelheim Investigational Site

Aalst, Belgium

Location

1199.52.3205 Boehringer Ingelheim Investigational Site

Bonheiden, Belgium

Location

1199.52.3202 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1199.52.3207 Boehringer Ingelheim Investigational Site

Charleroi, Belgium

Location

1199.52.3204 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1199.52.3203 Boehringer Ingelheim Investigational Site

Haine-Saint-Paul, Belgium

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1199.52.3201 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1199.52.3206 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1199.52.3521 Boehringer Ingelheim Investigational Site

Luxembourg, Belgium

Location

1199.52.1003 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1199.52.1004 Boehringer Ingelheim Investigational Site

Edmonton, Ontario, Canada

Location

1199.52.1001 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1199.52.1002 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1199.52.4202 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1199.52.4204 Boehringer Ingelheim Investigational Site

Hradec Králové, Czechia

Location

1199.52.4201 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1199.52.4502 Boehringer Ingelheim Investigational Site

Herning, Denmark

Location

1199.52.4501 Boehringer Ingelheim Investigational Site

København Ø, Denmark

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1199.52.4503 Boehringer Ingelheim Investigational Site

Næstved, Denmark

Location

1199.52.4504 Boehringer Ingelheim Investigational Site

Odense C, Denmark

Location

1199.52.3304 Boehringer Ingelheim Investigational Site

Lille, France

Location

1199.52.3307 Boehringer Ingelheim Investigational Site

Lyon, France

Location

1199.52.3305 Boehringer Ingelheim Investigational Site

Paris, France

Location

1199.52.3301 Boehringer Ingelheim Investigational Site

Reims, France

Location

1199.52.4906 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1199.52.4905 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

1199.52.4904 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

1199.52.4903 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1199.52.4901 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

1199.52.8501 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1199.52.8502 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1199.52.8503 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

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1199.52.8504 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1199.52.9706 Boehringer Ingelheim Investigational Site

Beersheba, Israel

Location

1199.52.9704 Boehringer Ingelheim Investigational Site

Petah Tikva, Israel

Location

1199.52.9703 Boehringer Ingelheim Investigational Site

Tel Aviv, Israel

Location

1199.52.3901 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1199.52.3906 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1199.52.3907 Boehringer Ingelheim Investigational Site

Napoli, Italy

Location

1199.52.3905 Boehringer Ingelheim Investigational Site

Padua, Italy

Location

1199.52.3903 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1199.52.3904 Boehringer Ingelheim Investigational Site

San Giovanni Rotondo (FG), Italy

Location

1199.52.8102 Boehringer Ingelheim Investigational Site

Aichi, Nagoya, Japan

Location

1199.52.8105 Boehringer Ingelheim Investigational Site

Chiba, Chiba, Japan

Location

1199.52.8101 Boehringer Ingelheim Investigational Site

Chiba, Kashiwa, Japan

Location

1199.52.8107 Boehringer Ingelheim Investigational Site

Ehime, Matsuyama, Japan

Location

1199.52.8106 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

1199.52.8108 Boehringer Ingelheim Investigational Site

Hokkaido, Sapporo, Japan

Location

1199.52.8115 Boehringer Ingelheim Investigational Site

Hyogo, Amagasaki, Japan

Location

1199.52.8112 Boehringer Ingelheim Investigational Site

Hyogo, Kobe, Japan

Location

1199.52.8114 Boehringer Ingelheim Investigational Site

Ibaraki, Tsukuba, Japan

Location

1199.52.8110 Boehringer Ingelheim Investigational Site

Oita, Yufu, Japan

Location

1199.52.8116 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1199.52.8103 Boehringer Ingelheim Investigational Site

Osaka, Suita, Japan

Location

1199.52.8109 Boehringer Ingelheim Investigational Site

Saitama, Kitaadachi-gun, Japan

Location

1199.52.8104 Boehringer Ingelheim Investigational Site

Shizuoka, Sunto-gun, Japan

Location

1199.52.8113 Boehringer Ingelheim Investigational Site

Tokyo , Shinagawa-ku, Japan

Location

1199.52.8111 Boehringer Ingelheim Investigational Site

Tokyo, Koto-ku, Japan

Location

1199.52.5201 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1199.52.3101 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1199.52.3103 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1199.52.3102 Boehringer Ingelheim Investigational Site

Utrecht, Netherlands

Location

1199.52.4801 Boehringer Ingelheim Investigational Site

Jelenia Góra, Poland

Location

1199.52.4803 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

1199.52.4804 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

Location

1199.52.3504 Boehringer Ingelheim Investigational Site

Almada, Portugal

Location

1199.52.3502 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

1199.52.3505 Boehringer Ingelheim Investigational Site

Loures, Portugal

Location

1199.52.3501 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

1199.52.3506 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

1199.52.0701 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1199.52.0703 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1199.52.0702 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1199.52.0707 Boehringer Ingelheim Investigational Site

Tyumen, Russia

Location

1199.52.8202 Boehringer Ingelheim Investigational Site

Goyang, South Korea

Location

1199.52.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1199.52.8203 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1199.52.8204 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1199.52.3406 Boehringer Ingelheim Investigational Site

A Coruña, Spain

Location

1199.52.3401 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1199.52.3402 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, Spain

Location

1199.52.3403 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1199.52.3404 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1199.52.3405 Boehringer Ingelheim Investigational Site

Santander, Spain

Location

1199.52.3407 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1199.52.4601 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1199.52.4602 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1199.52.8805 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1199.52.8801 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1199.52.8803 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1199.52.8802 Boehringer Ingelheim Investigational Site

Taoyuan, Taiwan

Location

1199.52.9005 Boehringer Ingelheim Investigational Site

Adana, Turkey (Türkiye)

Location

1199.52.9001 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1199.52.9003 Boehringer Ingelheim Investigational Site

Antalya, Turkey (Türkiye)

Location

1199.52.9004 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1199.52.9002 Boehringer Ingelheim Investigational Site

Izmir, Turkey (Türkiye)

Location

1199.52.4401 Boehringer Ingelheim Investigational Site

Aberdeen, United Kingdom

Location

1199.52.4403 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1199.52.4402 Boehringer Ingelheim Investigational Site

Middlesex, United Kingdom

Location

1199.52.4405 Boehringer Ingelheim Investigational Site

Nottingham, United Kingdom

Location

1199.52.4404 Boehringer Ingelheim Investigational Site

Southampton, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 30010751 DERIVED

• 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.

  PMID: 26603056 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: May 29, 2014
• Study Start: September 25, 2014
• Primary Completion: May 13, 2016
• Study Completion: August 25, 2016
• Last Updated: July 21, 2017
• Results First Posted: July 21, 2017

Record last verified: 2017-06

Locations

TW (4); TU (5); PL (3); HK (4); NL (3); ME (1); RU (4); BE (9); US (14); PT (5); ES (7); GB (5); IL (3); KR (4); IT (6); SE (2); CA (4); DK (4); FR (4); AU (6); AR (5); JP (16); DE (5); CZ (3)