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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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

Study Design
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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


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


Outcome Measures
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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).


Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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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    
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
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nintedanib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action