Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

23 juni 2017 uppdaterad av: Boehringer Ingelheim

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.

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

768

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Cdad. de Córdoba, Argentina
        • 1199.52.5404 Boehringer Ingelheim Investigational Site
      • Cdad. de Córdoba, Argentina
        • 1199.52.5405 Boehringer Ingelheim Investigational Site
      • Ciudad Autónoma de Bs As, 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
  • Australien
    • New South Wales
      • Concord, New South Wales, Australien
        • 1199.52.6102 Boehringer Ingelheim Investigational Site
      • St Leonards, New South Wales, Australien
        • 1199.52.6103 Boehringer Ingelheim Investigational Site
      • Wollongong, New South Wales, Australien
        • 1199.52.6101 Boehringer Ingelheim Investigational Site
    • Victoria
      • Heidelberg, Victoria, Australien
        • 1199.52.6104 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australien
        • 1199.52.6105 Boehringer Ingelheim Investigational Site
      • Perth, Western Australia, Australien
        • 1199.52.6106 Boehringer Ingelheim Investigational Site
  • Belgien
      • Aalst, Belgien
        • 1199.52.3208 Boehringer Ingelheim Investigational Site
      • Bonheiden, Belgien
        • 1199.52.3205 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgien
        • 1199.52.3202 Boehringer Ingelheim Investigational Site
      • Charleroi, Belgien
        • 1199.52.3207 Boehringer Ingelheim Investigational Site
      • Edegem, Belgien
        • 1199.52.3204 Boehringer Ingelheim Investigational Site
      • Haine-Saint-Paul, Belgien
        • 1199.52.3203 Boehringer Ingelheim Investigational Site
      • Leuven, Belgien
        • 1199.52.3201 Boehringer Ingelheim Investigational Site
      • Liège, Belgien
        • 1199.52.3206 Boehringer Ingelheim Investigational Site
      • Luxembourg, Belgien
        • 1199.52.3521 Boehringer Ingelheim Investigational Site
  • Danmark
      • Herning, Danmark
        • 1199.52.4502 Boehringer Ingelheim Investigational Site
      • København Ø, Danmark
        • 1199.52.4501 Boehringer Ingelheim Investigational Site
      • Næstved, Danmark
        • 1199.52.4503 Boehringer Ingelheim Investigational Site
      • Odense C, Danmark
        • 1199.52.4504 Boehringer Ingelheim Investigational Site
  • Frankrike
      • Lille cedex, Frankrike
        • 1199.52.3304 Boehringer Ingelheim Investigational Site
      • Lyon cedex 8, Frankrike
        • 1199.52.3307 Boehringer Ingelheim Investigational Site
      • Paris cedex 15, Frankrike
        • 1199.52.3305 Boehringer Ingelheim Investigational Site
      • Reims Cedex, Frankrike
        • 1199.52.3301 Boehringer Ingelheim Investigational Site
  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna
        • 1199.52.0108 Boehringer Ingelheim Investigational Site
    • Connecticut
      • New Haven, Connecticut, Förenta staterna
        • 1199.52.0105 Boehringer Ingelheim Investigational Site
      • Plainville, Connecticut, Förenta staterna
        • 1199.52.0101 Boehringer Ingelheim Investigational Site
    • Illinois
      • Arlington Heights, Illinois, Förenta staterna
        • 1199.52.0121 Boehringer Ingelheim Investigational Site
    • Iowa
      • Sioux City, Iowa, Förenta staterna
        • 1199.52.0123 Boehringer Ingelheim Investigational Site
    • Kansas
      • Topeka, Kansas, Förenta staterna
        • 1199.52.0104 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna
        • 1199.52.0114 Boehringer Ingelheim Investigational Site
    • Michigan
      • Detroit, Michigan, Förenta staterna
        • 1199.52.0113 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, Förenta staterna
        • 1199.52.0125 Boehringer Ingelheim Investigational Site
    • New York
      • Johnson City, New York, Förenta staterna
        • 1199.52.0119 Boehringer Ingelheim Investigational Site
    • Ohio
      • Canton, Ohio, Förenta staterna
        • 1199.52.0115 Boehringer Ingelheim Investigational Site
      • Sylvania, Ohio, Förenta staterna
        • 1199.52.0106 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Nashville, Tennessee, Förenta staterna
        • 1199.52.0102 Boehringer Ingelheim Investigational Site
    • Texas
      • Fort Worth, Texas, Förenta staterna
        • 1199.52.0120 Boehringer Ingelheim Investigational Site
  • Hong Kong
      • Hong Kong, 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
  • Israel
      • Beer Sheva, Israel
        • 1199.52.9706 Boehringer Ingelheim Investigational Site
      • Petach Tikva, Israel
        • 1199.52.9704 Boehringer Ingelheim Investigational Site
      • Tel Aviv, Israel
        • 1199.52.9703 Boehringer Ingelheim Investigational Site
  • Italien
      • Genova, Italien
        • 1199.52.3901 Boehringer Ingelheim Investigational Site
      • Milano, Italien
        • 1199.52.3906 Boehringer Ingelheim Investigational Site
      • Napoli, Italien
        • 1199.52.3907 Boehringer Ingelheim Investigational Site
      • Padova, Italien
        • 1199.52.3905 Boehringer Ingelheim Investigational Site
      • Pisa, Italien
        • 1199.52.3903 Boehringer Ingelheim Investigational Site
      • San Giovanni Rotondo (FG), Italien
        • 1199.52.3904 Boehringer Ingelheim Investigational Site
  • Japan
      • Aichi, Nagoya, Japan
        • 1199.52.8102 Boehringer Ingelheim Investigational Site
      • Chiba, Chiba, Japan
        • 1199.52.8105 Boehringer Ingelheim Investigational Site
      • Chiba, Kashiwa, Japan
        • 1199.52.8101 Boehringer Ingelheim Investigational Site
      • Ehime, Matsuyama, Japan
        • 1199.52.8107 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japan
        • 1199.52.8106 Boehringer Ingelheim Investigational Site
      • Hokkaido, Sapporo, Japan
        • 1199.52.8108 Boehringer Ingelheim Investigational Site
      • Hyogo, Amagasaki, Japan
        • 1199.52.8115 Boehringer Ingelheim Investigational Site
      • Hyogo, Kobe, Japan
        • 1199.52.8112 Boehringer Ingelheim Investigational Site
      • Ibaraki, Tsukuba, Japan
        • 1199.52.8114 Boehringer Ingelheim Investigational Site
      • Oita, Yufu, Japan
        • 1199.52.8110 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1199.52.8116 Boehringer Ingelheim Investigational Site
      • Osaka, Suita, Japan
        • 1199.52.8103 Boehringer Ingelheim Investigational Site
      • Saitama, Kitaadachi-gun, Japan
        • 1199.52.8109 Boehringer Ingelheim Investigational Site
      • Shizuoka, Sunto-gun, Japan
        • 1199.52.8104 Boehringer Ingelheim Investigational Site
      • Tokyo , Shinagawa-ku, Japan
        • 1199.52.8113 Boehringer Ingelheim Investigational Site
      • Tokyo, Koto-ku, Japan
        • 1199.52.8111 Boehringer Ingelheim Investigational Site
  • Kalkon
      • Adana, Kalkon
        • 1199.52.9005 Boehringer Ingelheim Investigational Site
      • Ankara, Kalkon
        • 1199.52.9001 Boehringer Ingelheim Investigational Site
      • Antalya, Kalkon
        • 1199.52.9003 Boehringer Ingelheim Investigational Site
      • Istanbul, Kalkon
        • 1199.52.9004 Boehringer Ingelheim Investigational Site
      • Izmir, Kalkon
        • 1199.52.9002 Boehringer Ingelheim Investigational Site
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada
        • 1199.52.1003 Boehringer Ingelheim Investigational Site
    • Ontario
      • Edmonton, Ontario, Kanada
        • 1199.52.1004 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Kanada
        • 1199.52.1001 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Kanada
        • 1199.52.1002 Boehringer Ingelheim Investigational Site
  • Korea, Republiken av
      • Goyang, Korea, Republiken av
        • 1199.52.8202 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republiken av
        • 1199.52.8201 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republiken av
        • 1199.52.8203 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republiken av
        • 1199.52.8204 Boehringer Ingelheim Investigational Site
  • Mexiko
      • Mexico, Mexiko
        • 1199.52.5201 Boehringer Ingelheim Investigational Site
  • Nederländerna
      • Amsterdam, Nederländerna
        • 1199.52.3101 Boehringer Ingelheim Investigational Site
      • Amsterdam, Nederländerna
        • 1199.52.3103 Boehringer Ingelheim Investigational Site
      • Utrecht, Nederländerna
        • 1199.52.3102 Boehringer Ingelheim Investigational Site
  • Polen
      • Jelenia Gora, Polen
        • 1199.52.4801 Boehringer Ingelheim Investigational Site
      • Poznan, Polen
        • 1199.52.4803 Boehringer Ingelheim Investigational Site
      • Wroclaw, Polen
        • 1199.52.4804 Boehringer Ingelheim Investigational Site
  • Portugal
      • Almada, Portugal
        • 1199.52.3504 Boehringer Ingelheim Investigational Site
      • Coimbra, Portugal
        • 1199.52.3502 Boehringer Ingelheim Investigational Site
      • Loures, Portugal
        • 1199.52.3505 Boehringer Ingelheim Investigational Site
      • Porto, Portugal
        • 1199.52.3501 Boehringer Ingelheim Investigational Site
      • Porto, Portugal
        • 1199.52.3506 Boehringer Ingelheim Investigational Site
  • Ryska Federationen
      • Moscow, Ryska Federationen
        • 1199.52.0701 Boehringer Ingelheim Investigational Site
      • Moscow, Ryska Federationen
        • 1199.52.0703 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Ryska Federationen
        • 1199.52.0702 Boehringer Ingelheim Investigational Site
      • Tyumen, Ryska Federationen
        • 1199.52.0707 Boehringer Ingelheim Investigational Site
  • Spanien
      • Barcelona, Spanien
        • 1199.52.3401 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, Spanien
        • 1199.52.3402 Boehringer Ingelheim Investigational Site
      • La Coruña, Spanien
        • 1199.52.3406 Boehringer Ingelheim Investigational Site
      • Madrid, Spanien
        • 1199.52.3403 Boehringer Ingelheim Investigational Site
      • Madrid, Spanien
        • 1199.52.3404 Boehringer Ingelheim Investigational Site
      • Santander, Spanien
        • 1199.52.3405 Boehringer Ingelheim Investigational Site
      • Sevilla, Spanien
        • 1199.52.3407 Boehringer Ingelheim Investigational Site
  • Storbritannien
      • Aberdeen, Storbritannien
        • 1199.52.4401 Boehringer Ingelheim Investigational Site
      • Manchester, Storbritannien
        • 1199.52.4403 Boehringer Ingelheim Investigational Site
      • Middlesex, Storbritannien
        • 1199.52.4402 Boehringer Ingelheim Investigational Site
      • Nottingham, Storbritannien
        • 1199.52.4405 Boehringer Ingelheim Investigational Site
      • Southampton, Storbritannien
        • 1199.52.4404 Boehringer Ingelheim Investigational Site
  • Sverige
      • Stockholm, Sverige
        • 1199.52.4601 Boehringer Ingelheim Investigational Site
      • Uppsala, Sverige
        • 1199.52.4602 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan
        • 1199.52.8805 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1199.52.8801 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1199.52.8803 Boehringer Ingelheim Investigational Site
      • Taoyuan County, Taiwan
        • 1199.52.8802 Boehringer Ingelheim Investigational Site
  • Tjeckien
      • Brno, Tjeckien
        • 1199.52.4202 Boehringer Ingelheim Investigational Site
      • Hradec Kralove, Tjeckien
        • 1199.52.4204 Boehringer Ingelheim Investigational Site
      • Prague, Tjeckien
        • 1199.52.4201 Boehringer Ingelheim Investigational Site
  • Tyskland
      • Dresden, Tyskland
        • 1199.52.4906 Boehringer Ingelheim Investigational Site
      • Essen, Tyskland
        • 1199.52.4905 Boehringer Ingelheim Investigational Site
      • Freiburg, Tyskland
        • 1199.52.4904 Boehringer Ingelheim Investigational Site
      • Mannheim, Tyskland
        • 1199.52.4903 Boehringer Ingelheim Investigational Site
      • Ulm, Tyskland
        • 1199.52.4901 Boehringer Ingelheim Investigational Site
  • Österrike
      • Linz, Österrike
        • 1199.52.4302 Boehringer Ingelheim Investigational Site
      • Wien, Österrike
        • 1199.52.4303 Boehringer Ingelheim Investigational Site
      • Wien, Österrike
        • 1199.52.4304 Boehringer Ingelheim Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Nintedanib (BIBF 1120) + BSC
Läkemedel: Nintedanib (BIBF 1120)
Läkemedel: BSC
Placebo-jämförare: Placebo + BSC
Läkemedel: Placebo
Läkemedel: BSC

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-Free Survival (PFS) by Central Review Assessment
Tidsram: 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.
From randomisation until cut-off date 14JUN2016.
Overall Survival (OS)
Tidsram: 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.
From randomisation until cut-off date 14JUN2016.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment
Tidsram: 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.
From randomisation until cut-off date 14JUN2016.
Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment
Tidsram: From randomisation until cut-off date 14JUN2016.
Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).
From randomisation until cut-off date 14JUN2016.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 september 2014

Primärt slutförande (Faktisk)

13 maj 2016

Avslutad studie (Faktisk)

25 augusti 2016

Studieregistreringsdatum

Först inskickad

26 maj 2014

Först inskickad som uppfyllde QC-kriterierna

26 maj 2014

Första postat (Uppskatta)

29 maj 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 juli 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juni 2017

Senast verifierad

1 juni 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1199.52
  • 2012-000095-42 (EudraCT-nummer: EudraCT)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera