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Trial record 13 of 19 for:    colon cancer | ( Map: Mexico )

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

Tracking Information
First Submitted Date  ICMJE May 26, 2014
First Posted Date  ICMJE May 29, 2014
Results First Submitted Date  ICMJE May 8, 2017
Results First Posted Date  ICMJE July 21, 2017
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE September 25, 2014
Actual Primary Completion Date May 13, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2014)
Primary endpoint is progression free survival (PFS) [ Time Frame: 22 months ]
Change History Complete list of historical versions of study NCT02149108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2014)
  • Key secondary endpoint is Overall survival (OS) [ Time Frame: 22 months ]
  • Objective tumour response [ Time Frame: 22 months ]
  • Disease control [ Time Frame: 22 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE
  • Drug: Nintedanib (BIBF 1120)
  • Drug: Placebo
  • Drug: BSC
Study Arms  ICMJE
  • Experimental: Nintedanib (BIBF 1120) + BSC
    Interventions:
    • Drug: Nintedanib (BIBF 1120)
    • Drug: BSC
  • Placebo Comparator: Placebo + BSC
    Interventions:
    • Drug: Placebo
    • Drug: BSC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2016)
768
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2014)
764
Actual Study Completion Date  ICMJE August 25, 2016
Actual Primary Completion Date May 13, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Argentina,   Australia,   Austria,   Belgium,   Canada,   Czechia,   Denmark,   France,   Germany,   Hong Kong,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Portugal,   Russian Federation,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Luxembourg
 
Administrative Information
NCT Number  ICMJE NCT02149108
Other Study ID Numbers  ICMJE 1199.52
2012-000095-42 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP