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

23. juni 2017 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

768

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia
        • 1199.52.6102 Boehringer Ingelheim Investigational Site
      • St Leonards, New South Wales, Australia
        • 1199.52.6103 Boehringer Ingelheim Investigational Site
      • Wollongong, New South Wales, Australia
        • 1199.52.6101 Boehringer Ingelheim Investigational Site
    • Victoria
      • Heidelberg, Victoria, Australia
        • 1199.52.6104 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • 1199.52.6105 Boehringer Ingelheim Investigational Site
      • Perth, Western Australia, Australia
        • 1199.52.6106 Boehringer Ingelheim Investigational Site
  • Belgia
      • Aalst, Belgia
        • 1199.52.3208 Boehringer Ingelheim Investigational Site
      • Bonheiden, Belgia
        • 1199.52.3205 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgia
        • 1199.52.3202 Boehringer Ingelheim Investigational Site
      • Charleroi, Belgia
        • 1199.52.3207 Boehringer Ingelheim Investigational Site
      • Edegem, Belgia
        • 1199.52.3204 Boehringer Ingelheim Investigational Site
      • Haine-Saint-Paul, Belgia
        • 1199.52.3203 Boehringer Ingelheim Investigational Site
      • Leuven, Belgia
        • 1199.52.3201 Boehringer Ingelheim Investigational Site
      • Liège, Belgia
        • 1199.52.3206 Boehringer Ingelheim Investigational Site
      • Luxembourg, Belgia
        • 1199.52.3521 Boehringer Ingelheim Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1199.52.1003 Boehringer Ingelheim Investigational Site
    • Ontario
      • Edmonton, Ontario, Canada
        • 1199.52.1004 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1199.52.1001 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1199.52.1002 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
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen
        • 1199.52.0701 Boehringer Ingelheim Investigational Site
      • Moscow, Den russiske føderasjonen
        • 1199.52.0703 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Den russiske føderasjonen
        • 1199.52.0702 Boehringer Ingelheim Investigational Site
      • Tyumen, Den russiske føderasjonen
        • 1199.52.0707 Boehringer Ingelheim Investigational Site
  • Forente stater
    • California
      • Los Angeles, California, Forente stater
        • 1199.52.0108 Boehringer Ingelheim Investigational Site
    • Connecticut
      • New Haven, Connecticut, Forente stater
        • 1199.52.0105 Boehringer Ingelheim Investigational Site
      • Plainville, Connecticut, Forente stater
        • 1199.52.0101 Boehringer Ingelheim Investigational Site
    • Illinois
      • Arlington Heights, Illinois, Forente stater
        • 1199.52.0121 Boehringer Ingelheim Investigational Site
    • Iowa
      • Sioux City, Iowa, Forente stater
        • 1199.52.0123 Boehringer Ingelheim Investigational Site
    • Kansas
      • Topeka, Kansas, Forente stater
        • 1199.52.0104 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Forente stater
        • 1199.52.0114 Boehringer Ingelheim Investigational Site
    • Michigan
      • Detroit, Michigan, Forente stater
        • 1199.52.0113 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forente stater
        • 1199.52.0125 Boehringer Ingelheim Investigational Site
    • New York
      • Johnson City, New York, Forente stater
        • 1199.52.0119 Boehringer Ingelheim Investigational Site
    • Ohio
      • Canton, Ohio, Forente stater
        • 1199.52.0115 Boehringer Ingelheim Investigational Site
      • Sylvania, Ohio, Forente stater
        • 1199.52.0106 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Nashville, Tennessee, Forente stater
        • 1199.52.0102 Boehringer Ingelheim Investigational Site
    • Texas
      • Fort Worth, Texas, Forente stater
        • 1199.52.0120 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
  • 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
  • Italia
      • Genova, Italia
        • 1199.52.3901 Boehringer Ingelheim Investigational Site
      • Milano, Italia
        • 1199.52.3906 Boehringer Ingelheim Investigational Site
      • Napoli, Italia
        • 1199.52.3907 Boehringer Ingelheim Investigational Site
      • Padova, Italia
        • 1199.52.3905 Boehringer Ingelheim Investigational Site
      • Pisa, Italia
        • 1199.52.3903 Boehringer Ingelheim Investigational Site
      • San Giovanni Rotondo (FG), Italia
        • 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
  • Korea, Republikken
      • Goyang, Korea, Republikken
        • 1199.52.8202 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republikken
        • 1199.52.8201 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republikken
        • 1199.52.8203 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republikken
        • 1199.52.8204 Boehringer Ingelheim Investigational Site
  • Mexico
      • Mexico, Mexico
        • 1199.52.5201 Boehringer Ingelheim Investigational Site
  • Nederland
      • Amsterdam, Nederland
        • 1199.52.3101 Boehringer Ingelheim Investigational Site
      • Amsterdam, Nederland
        • 1199.52.3103 Boehringer Ingelheim Investigational Site
      • Utrecht, Nederland
        • 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
  • Spania
      • Barcelona, Spania
        • 1199.52.3401 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, Spania
        • 1199.52.3402 Boehringer Ingelheim Investigational Site
      • La Coruña, Spania
        • 1199.52.3406 Boehringer Ingelheim Investigational Site
      • Madrid, Spania
        • 1199.52.3403 Boehringer Ingelheim Investigational Site
      • Madrid, Spania
        • 1199.52.3404 Boehringer Ingelheim Investigational Site
      • Santander, Spania
        • 1199.52.3405 Boehringer Ingelheim Investigational Site
      • Sevilla, Spania
        • 1199.52.3407 Boehringer Ingelheim Investigational Site
  • Storbritannia
      • Aberdeen, Storbritannia
        • 1199.52.4401 Boehringer Ingelheim Investigational Site
      • Manchester, Storbritannia
        • 1199.52.4403 Boehringer Ingelheim Investigational Site
      • Middlesex, Storbritannia
        • 1199.52.4402 Boehringer Ingelheim Investigational Site
      • Nottingham, Storbritannia
        • 1199.52.4405 Boehringer Ingelheim Investigational Site
      • Southampton, Storbritannia
        • 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
  • Tsjekkia
      • Brno, Tsjekkia
        • 1199.52.4202 Boehringer Ingelheim Investigational Site
      • Hradec Kralove, Tsjekkia
        • 1199.52.4204 Boehringer Ingelheim Investigational Site
      • Prague, Tsjekkia
        • 1199.52.4201 Boehringer Ingelheim Investigational Site
  • Tyrkia
      • Adana, Tyrkia
        • 1199.52.9005 Boehringer Ingelheim Investigational Site
      • Ankara, Tyrkia
        • 1199.52.9001 Boehringer Ingelheim Investigational Site
      • Antalya, Tyrkia
        • 1199.52.9003 Boehringer Ingelheim Investigational Site
      • Istanbul, Tyrkia
        • 1199.52.9004 Boehringer Ingelheim Investigational Site
      • Izmir, Tyrkia
        • 1199.52.9002 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
  • Østerrike
      • Linz, Østerrike
        • 1199.52.4302 Boehringer Ingelheim Investigational Site
      • Wien, Østerrike
        • 1199.52.4303 Boehringer Ingelheim Investigational Site
      • Wien, Østerrike
        • 1199.52.4304 Boehringer Ingelheim Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Nintedanib (BIBF 1120) + BSC
Legemiddel: Nintedanib (BIBF 1120)
Legemiddel: BSC
Placebo komparator: Placebo + BSC
Legemiddel: Placebo
Legemiddel: BSC

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival (PFS) by Central Review Assessment
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. september 2014

Primær fullføring (Faktiske)

13. mai 2016

Studiet fullført (Faktiske)

25. august 2016

Datoer for studieregistrering

Først innsendt

26. mai 2014

Først innsendt som oppfylte QC-kriteriene

26. mai 2014

Først lagt ut (Anslag)

29. mai 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere