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

NCT ID: NCT02149108

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 768 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-25
• Study Completion Date: 2016-08-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nintedanib (BIBF 1120) + BSC

Group Type: EXPERIMENTAL

Nintedanib (BIBF 1120)

Intervention Type: DRUG

BSC

Intervention Type: DRUG

Placebo + BSC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

BSC

Intervention Type: DRUG

Interventions

Nintedanib (BIBF 1120)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

BSC

Intervention Type: DRUG

BSC

Intervention Type: DRUG

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• Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity.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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1199.52.0108 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1199.52.0105 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

1199.52.0101 Boehringer Ingelheim Investigational Site

Plainville, Connecticut, United States

1199.52.0121 Boehringer Ingelheim Investigational Site

Arlington Heights, Illinois, United States

1199.52.0123 Boehringer Ingelheim Investigational Site

Sioux City, Iowa, United States

1199.52.0104 Boehringer Ingelheim Investigational Site

Topeka, Kansas, United States

1199.52.0114 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

1199.52.0113 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

1199.52.0125 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

1199.52.0119 Boehringer Ingelheim Investigational Site

Johnson City, New York, United States

1199.52.0115 Boehringer Ingelheim Investigational Site

Canton, Ohio, United States

1199.52.0106 Boehringer Ingelheim Investigational Site

Sylvania, Ohio, United States

1199.52.0102 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

1199.52.0120 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

1199.52.5404 Boehringer Ingelheim Investigational Site

Cdad. de Córdoba, , Argentina

1199.52.5405 Boehringer Ingelheim Investigational Site

Cdad. de Córdoba, , Argentina

1199.52.5401 Boehringer Ingelheim Investigational Site

Ciudad Autónoma de Bs As, , Argentina

1199.52.5403 Boehringer Ingelheim Investigational Site

Ciudad Autónoma de Bs As, , Argentina

1199.52.5406 Boehringer Ingelheim Investigational Site

Ciudad Autónoma de Bs As, , Argentina

1199.52.6102 Boehringer Ingelheim Investigational Site

Concord, New South Wales, Australia

1199.52.6103 Boehringer Ingelheim Investigational Site

St Leonards, New South Wales, Australia

1199.52.6101 Boehringer Ingelheim Investigational Site

Wollongong, New South Wales, Australia

1199.52.6104 Boehringer Ingelheim Investigational Site

Heidelberg, Victoria, Australia

1199.52.6105 Boehringer Ingelheim Investigational Site

Nedlands, Western Australia, Australia

1199.52.6106 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

1199.52.4302 Boehringer Ingelheim Investigational Site

Linz, , Austria

1199.52.4303 Boehringer Ingelheim Investigational Site

Vienna, , Austria

1199.52.4304 Boehringer Ingelheim Investigational Site

Vienna, , Austria

1199.52.3208 Boehringer Ingelheim Investigational Site

Aalst, , Belgium

1199.52.3205 Boehringer Ingelheim Investigational Site

Bonheiden, , Belgium

1199.52.3202 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1199.52.3207 Boehringer Ingelheim Investigational Site

Charleroi, , Belgium

1199.52.3204 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

1199.52.3203 Boehringer Ingelheim Investigational Site

Haine-Saint-Paul, , Belgium

1199.52.3201 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

1199.52.3206 Boehringer Ingelheim Investigational Site

Liège, , Belgium

1199.52.3521 Boehringer Ingelheim Investigational Site

Luxembourg, , Belgium

1199.52.1003 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

1199.52.1004 Boehringer Ingelheim Investigational Site

Edmonton, Ontario, Canada

1199.52.1001 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

1199.52.1002 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

1199.52.4202 Boehringer Ingelheim Investigational Site

Brno, , Czechia

1199.52.4204 Boehringer Ingelheim Investigational Site

Hradec Králové, , Czechia

1199.52.4201 Boehringer Ingelheim Investigational Site

Prague, , Czechia

1199.52.4502 Boehringer Ingelheim Investigational Site

Herning, , Denmark

1199.52.4501 Boehringer Ingelheim Investigational Site

København Ø, , Denmark

1199.52.4503 Boehringer Ingelheim Investigational Site

Næstved, , Denmark

1199.52.4504 Boehringer Ingelheim Investigational Site

Odense C, , Denmark

1199.52.3304 Boehringer Ingelheim Investigational Site

Lille, , France

1199.52.3307 Boehringer Ingelheim Investigational Site

Lyon, , France

1199.52.3305 Boehringer Ingelheim Investigational Site

Paris, , France

1199.52.3301 Boehringer Ingelheim Investigational Site

Reims, , France

1199.52.4906 Boehringer Ingelheim Investigational Site

Dresden, , Germany

1199.52.4905 Boehringer Ingelheim Investigational Site

Essen, , Germany

1199.52.4904 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

1199.52.4903 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

1199.52.4901 Boehringer Ingelheim Investigational Site

Ulm, , Germany

1199.52.8501 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

1199.52.8502 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

1199.52.8503 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

1199.52.8504 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

1199.52.9706 Boehringer Ingelheim Investigational Site

Beersheba, , Israel

1199.52.9704 Boehringer Ingelheim Investigational Site

Petah Tikva, , Israel

1199.52.9703 Boehringer Ingelheim Investigational Site

Tel Aviv, , Israel

1199.52.3901 Boehringer Ingelheim Investigational Site

Genova, , Italy

1199.52.3906 Boehringer Ingelheim Investigational Site

Milan, , Italy

1199.52.3907 Boehringer Ingelheim Investigational Site

Napoli, , Italy

1199.52.3905 Boehringer Ingelheim Investigational Site

Padua, , Italy

1199.52.3903 Boehringer Ingelheim Investigational Site

Pisa, , Italy

1199.52.3904 Boehringer Ingelheim Investigational Site

San Giovanni Rotondo (FG), , Italy

1199.52.8102 Boehringer Ingelheim Investigational Site

Aichi, Nagoya, , Japan

1199.52.8105 Boehringer Ingelheim Investigational Site

Chiba, Chiba, , Japan

1199.52.8101 Boehringer Ingelheim Investigational Site

Chiba, Kashiwa, , Japan

1199.52.8107 Boehringer Ingelheim Investigational Site

Ehime, Matsuyama, , Japan

1199.52.8106 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

1199.52.8108 Boehringer Ingelheim Investigational Site

Hokkaido, Sapporo, , Japan

1199.52.8115 Boehringer Ingelheim Investigational Site

Hyogo, Amagasaki, , Japan

1199.52.8112 Boehringer Ingelheim Investigational Site

Hyogo, Kobe, , Japan

1199.52.8114 Boehringer Ingelheim Investigational Site

Ibaraki, Tsukuba, , Japan

1199.52.8110 Boehringer Ingelheim Investigational Site

Oita, Yufu, , Japan

1199.52.8116 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

1199.52.8103 Boehringer Ingelheim Investigational Site

Osaka, Suita, , Japan

1199.52.8109 Boehringer Ingelheim Investigational Site

Saitama, Kitaadachi-gun, , Japan

1199.52.8104 Boehringer Ingelheim Investigational Site

Shizuoka, Sunto-gun, , Japan

1199.52.8113 Boehringer Ingelheim Investigational Site

Tokyo , Shinagawa-ku, , Japan

1199.52.8111 Boehringer Ingelheim Investigational Site

Tokyo, Koto-ku, , Japan

1199.52.5201 Boehringer Ingelheim Investigational Site

México, , Mexico

1199.52.3101 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

1199.52.3103 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

1199.52.3102 Boehringer Ingelheim Investigational Site

Utrecht, , Netherlands

1199.52.4801 Boehringer Ingelheim Investigational Site

Jelenia Góra, , Poland

1199.52.4803 Boehringer Ingelheim Investigational Site

Poznan, , Poland

1199.52.4804 Boehringer Ingelheim Investigational Site

Wroclaw, , Poland

1199.52.3504 Boehringer Ingelheim Investigational Site

Almada, , Portugal

1199.52.3502 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

1199.52.3505 Boehringer Ingelheim Investigational Site

Loures, , Portugal

1199.52.3501 Boehringer Ingelheim Investigational Site

Porto, , Portugal

1199.52.3506 Boehringer Ingelheim Investigational Site

Porto, , Portugal

1199.52.0701 Boehringer Ingelheim Investigational Site

Moscow, , Russia

1199.52.0703 Boehringer Ingelheim Investigational Site

Moscow, , Russia

1199.52.0702 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

1199.52.0707 Boehringer Ingelheim Investigational Site

Tyumen, , Russia

1199.52.8202 Boehringer Ingelheim Investigational Site

Goyang, , South Korea

1199.52.8201 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1199.52.8203 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1199.52.8204 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

1199.52.3406 Boehringer Ingelheim Investigational Site

A Coruña, , Spain

1199.52.3401 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

1199.52.3402 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

1199.52.3403 Boehringer Ingelheim Investigational Site

Madrid, , Spain

1199.52.3404 Boehringer Ingelheim Investigational Site

Madrid, , Spain

1199.52.3405 Boehringer Ingelheim Investigational Site

Santander, , Spain

1199.52.3407 Boehringer Ingelheim Investigational Site

Seville, , Spain

1199.52.4601 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

1199.52.4602 Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

1199.52.8805 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

1199.52.8801 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

1199.52.8803 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

1199.52.8802 Boehringer Ingelheim Investigational Site

Taoyuan, , Taiwan

1199.52.9005 Boehringer Ingelheim Investigational Site

Adana, , Turkey (Türkiye)

1199.52.9001 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

1199.52.9003 Boehringer Ingelheim Investigational Site

Antalya, , Turkey (Türkiye)

1199.52.9004 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

1199.52.9002 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

1199.52.4401 Boehringer Ingelheim Investigational Site

Aberdeen, , United Kingdom

1199.52.4403 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

1199.52.4402 Boehringer Ingelheim Investigational Site

Middlesex, , United Kingdom

1199.52.4405 Boehringer Ingelheim Investigational Site

Nottingham, , United Kingdom

1199.52.4404 Boehringer Ingelheim Investigational Site

Southampton, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Canada; Czechia; Denmark; France; Germany; Hong Kong; Israel; Italy; Japan; Mexico; Netherlands; Poland; Portugal; Russia; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30010751 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26603056 (View on PubMed)

Other Identifiers

2012-000095-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.52

Identifier Type: -

Identifier Source: org_study_id