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Trial record 62 of 104 for:    colon cancer | ( Map: Nebraska, United States )

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

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ClinicalTrials.gov Identifier: NCT02149108
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Nintedanib (BIBF 1120) Drug: Placebo Drug: BSC Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 768 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Actual Study Start Date : September 25, 2014
Actual Primary Completion Date : May 13, 2016
Actual Study Completion Date : August 25, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nintedanib (BIBF 1120) + BSC Drug: Nintedanib (BIBF 1120)
Drug: BSC
Placebo Comparator: Placebo + BSC Drug: Placebo
Drug: BSC



Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment [ Time Frame: From randomisation until cut-off date 14JUN2016. ]
    Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.

  2. Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment [ Time Frame: From randomisation until cut-off date 14JUN2016. ]
    Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149108


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Locations
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United States, California
1199.52.0108 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
United States, Connecticut
1199.52.0105 Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States
1199.52.0101 Boehringer Ingelheim Investigational Site
Plainville, Connecticut, United States
United States, Illinois
1199.52.0121 Boehringer Ingelheim Investigational Site
Arlington Heights, Illinois, United States
United States, Iowa
1199.52.0123 Boehringer Ingelheim Investigational Site
Sioux City, Iowa, United States
United States, Kansas
1199.52.0104 Boehringer Ingelheim Investigational Site
Topeka, Kansas, United States
United States, Louisiana
1199.52.0114 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
United States, Michigan
1199.52.0113 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
United States, Nebraska
1199.52.0125 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
United States, New York
1199.52.0119 Boehringer Ingelheim Investigational Site
Johnson City, New York, United States
United States, Ohio
1199.52.0115 Boehringer Ingelheim Investigational Site
Canton, Ohio, United States
1199.52.0106 Boehringer Ingelheim Investigational Site
Sylvania, Ohio, United States
United States, Tennessee
1199.52.0102 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
United States, Texas
1199.52.0120 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
Argentina
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
Australia, New South Wales
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
Australia, Victoria
1199.52.6104 Boehringer Ingelheim Investigational Site
Heidelberg, Victoria, Australia
Australia, Western Australia
1199.52.6105 Boehringer Ingelheim Investigational Site
Nedlands, Western Australia, Australia
1199.52.6106 Boehringer Ingelheim Investigational Site
Perth, Western Australia, Australia
Austria
1199.52.4302 Boehringer Ingelheim Investigational Site
Linz, Austria
1199.52.4303 Boehringer Ingelheim Investigational Site
Wien, Austria
1199.52.4304 Boehringer Ingelheim Investigational Site
Wien, Austria
Belgium
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
Bruxelles, 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
Canada, British Columbia
1199.52.1003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Canada, Ontario
1199.52.1004 Boehringer Ingelheim Investigational Site
Edmonton, Ontario, Canada
1199.52.1001 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1199.52.1002 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Czechia
1199.52.4202 Boehringer Ingelheim Investigational Site
Brno, Czechia
1199.52.4204 Boehringer Ingelheim Investigational Site
Hradec Kralove, Czechia
1199.52.4201 Boehringer Ingelheim Investigational Site
Prague, Czechia
Denmark
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
France
1199.52.3304 Boehringer Ingelheim Investigational Site
Lille cedex, France
1199.52.3307 Boehringer Ingelheim Investigational Site
Lyon cedex 8, France
1199.52.3305 Boehringer Ingelheim Investigational Site
Paris cedex 15, France
1199.52.3301 Boehringer Ingelheim Investigational Site
Reims Cedex, France
Germany
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, Germany
1199.52.4903 Boehringer Ingelheim Investigational Site
Mannheim, Germany
1199.52.4901 Boehringer Ingelheim Investigational Site
Ulm, Germany
Hong Kong
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
Israel
1199.52.9706 Boehringer Ingelheim Investigational Site
Beer Sheva, Israel
1199.52.9704 Boehringer Ingelheim Investigational Site
Petach Tikva, Israel
1199.52.9703 Boehringer Ingelheim Investigational Site
Tel Aviv, Israel
Italy
1199.52.3901 Boehringer Ingelheim Investigational Site
Genova, Italy
1199.52.3906 Boehringer Ingelheim Investigational Site
Milano, Italy
1199.52.3907 Boehringer Ingelheim Investigational Site
Napoli, Italy
1199.52.3905 Boehringer Ingelheim Investigational Site
Padova, Italy
1199.52.3903 Boehringer Ingelheim Investigational Site
Pisa, Italy
1199.52.3904 Boehringer Ingelheim Investigational Site
San Giovanni Rotondo (FG), Italy
Japan
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
Korea, Republic of
1199.52.8202 Boehringer Ingelheim Investigational Site
Goyang, Korea, Republic of
1199.52.8201 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1199.52.8203 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1199.52.8204 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Mexico
1199.52.5201 Boehringer Ingelheim Investigational Site
Mexico, Mexico
Netherlands
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
Poland
1199.52.4801 Boehringer Ingelheim Investigational Site
Jelenia Gora, Poland
1199.52.4803 Boehringer Ingelheim Investigational Site
Poznan, Poland
1199.52.4804 Boehringer Ingelheim Investigational Site
Wroclaw, Poland
Portugal
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
Russian Federation
1199.52.0701 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1199.52.0703 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1199.52.0702 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1199.52.0707 Boehringer Ingelheim Investigational Site
Tyumen, Russian Federation
Spain
1199.52.3401 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1199.52.3402 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat, Spain
1199.52.3406 Boehringer Ingelheim Investigational Site
La Coruña, 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
Sevilla, Spain
Sweden
1199.52.4601 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
1199.52.4602 Boehringer Ingelheim Investigational Site
Uppsala, Sweden
Taiwan
1199.52.8805 Boehringer Ingelheim Investigational Site
Kaohsiung, 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 County, Taiwan
Turkey
1199.52.9005 Boehringer Ingelheim Investigational Site
Adana, Turkey
1199.52.9001 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1199.52.9003 Boehringer Ingelheim Investigational Site
Antalya, Turkey
1199.52.9004 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1199.52.9002 Boehringer Ingelheim Investigational Site
Izmir, Turkey
United Kingdom
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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02149108     History of Changes
Other Study ID Numbers: 1199.52
2012-000095-42 ( EudraCT Number: EudraCT )
First Posted: May 29, 2014    Key Record Dates
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action