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Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

15. august 2018 oppdatert av: Bayer

A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Eligible subjects were randomized 1:1 to sorafenib 800 mg daily or matching placebo. Progression was assessed every 8 weeks by modified RECIST criteria. Subjects had the option to unblind study treatment after progression and to receive open label sorafenib regardless of initial treatment assignment. Following discontinuation of study treatment, subjects were followed for survival every 3 months in long-term follow-up. Subjects who terminated study treatment (either double only or double blind and open label) for reasons other than death, lost to follow-up or consent withdrawn entered long-term follow up

Studietype

Intervensjonell

Registrering (Faktiske)

417

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Belgia
      • Bruxelles - Brussel, Belgia, 1000
  • Bulgaria
      • Sofia, Bulgaria, 1527
  • Danmark
      • Odense C, Danmark, 5000
  • Den russiske føderasjonen
      • Obninsk, Den russiske føderasjonen, 249036
  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90048
      • Stanford, California, Forente stater, 94305-5820
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06520
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
    • New York
      • New York, New York, Forente stater, 10029
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
      • Pittsburgh, Pennsylvania, Forente stater, 15213-1863
    • Texas
      • Houston, Texas, Forente stater, 77030
    • Washington
      • Seattle, Washington, Forente stater, 98109-1023
  • Frankrike
      • Angers, Frankrike, 49933
      • Bordeaux, Frankrike, 33076
      • Caen, Frankrike, 14076
      • LILLE cedex, Frankrike, 59037
      • Lyon, Frankrike, 69373
      • MARSEILLE cedex, Frankrike, 13273
      • Paris, Frankrike, 75651
      • Villejuif, Frankrike, 94805
  • Italia
    • Campania
      • Napoli, Campania, Italia, 80131
    • Liguria
      • Genova, Liguria, Italia, 16132
    • Lombardia
      • Milano, Lombardia, Italia, 20133
      • Milano, Lombardia, Italia, 20122
      • Milano, Lombardia, Italia, 20162
    • Sicilia
      • Catania, Sicilia, Italia, 95029
    • Toscana
      • Pisa, Toscana, Italia, 56124
      • Siena, Toscana, Italia, 53100
    • Umbria
      • Perugia, Umbria, Italia, 06126
  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
      • Nagoya, Aichi, Japan, 464-8681
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
  • Kina
      • Beijing, Kina, 100730
      • Beijing, Kina, 100021
      • Chengdu, Kina, 610041
      • Hangzhou, Kina, 310022
      • Shanghai, Kina, 200127
      • Shanghai, Kina, 200030
      • Tianjin, Kina, 300060
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
  • Korea, Republikken
      • Daejeon, Korea, Republikken, 301-721
      • Seoul, Korea, Republikken, 137-701
      • Seoul, Korea, Republikken, 110-744
      • Seoul, Korea, Republikken, 120-752
      • Seoul, Korea, Republikken, 135-710
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republikken, 138-736
        • Asan Medical Center
  • Nederland
      • Groningen, Nederland, 9713 GZ
      • Leiden, Nederland, 2333 ZA
  • Polen
      • Gliwice, Polen, 44-101
      • Poznan, Polen, 60-355
      • Warszawa, Polen, 02-781
      • Warszawa, Polen, 04-141
  • Saudi-Arabia
      • Riyadh, Saudi-Arabia, 11211
  • Spania
      • Barcelona, Spania, 08035
    • Madrid
      • Majadahonda, Madrid, Spania, 28222
  • Storbritannia
      • Cardiff, Storbritannia, CF14 2TL
      • Glasgow, Storbritannia, G12 0YN
      • Leeds, Storbritannia, LS9 7TF
      • London, Storbritannia, SE1 9RT
      • London, Storbritannia, SM2 5PT
      • Manchester, Storbritannia, M20 4BX
      • Newcastle Upon Tyne, Storbritannia, NE7 7DN
      • Sutton, Storbritannia, SM2 5PT
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, Storbritannia, AB25 2ZN
  • Sverige
      • Göteborg, Sverige, 413 45
      • Linköping, Sverige, 581 85
      • Lund, Sverige, 221 85
      • Stockholm, Sverige, 171 76
  • Tyskland
    • Bayern
      • Erlangen, Bayern, Tyskland, 91054
      • München, Bayern, Tyskland, 81377
      • Würzburg, Bayern, Tyskland, 97080
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Tyskland, 45122
      • Köln, Nordrhein-Westfalen, Tyskland, 50924
    • Sachsen
      • Leipzig, Sachsen, Tyskland, 04103
  • Østerrike
      • Wien, Østerrike, 1090

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:

  • Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell)
  • Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are eligible provided that the histology has no medullary differentiation nor anaplastic features
  • Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors] should be used as a basis for the assessment of disease progression)
  • RAI (radioactive iodine) refractory

Exclusion Criteria:

  • Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma)
  • Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF (vascular endothelial growth factor) or VEGF Receptors or other targeted agents
  • Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose chemotherapy for radiosensitization is allowed) or Thalidomide or any of its derivatives

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Sorafenib (Nexavar, BAY43-9006)
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
Legemiddel: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
Placebo komparator: Placebo
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
Legemiddel: Placebo
Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
Tidsramme: Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years
PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.
Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.
From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
Tidsramme: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Time to progression was defined at the time (days) from randomization to progression (based on central assessment [radiological and clinical progression due to bone irradiation])
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Disease Control Rate (DCR) Based on Central Assessment
Tidsramme: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Response Rate Based on Central Assessment
Tidsramme: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Duration of Response (DOR) Based on Central Assessment
Tidsramme: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Maximum Percent Reduction in Target Lesion Size Based on Central Assessment
Tidsramme: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State)
Tidsramme: A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)
Sorafenib AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state) was estimated from the steady state plasma concentration.
A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)

Samarbeidspartnere og etterforskere

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

Sponsor

Bayer

Samarbeidspartnere

Amgen

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)

15. oktober 2009

Primær fullføring (Faktiske)

31. august 2012

Studiet fullført (Faktiske)

30. august 2017

Datoer for studieregistrering

Først innsendt

24. september 2009

Først innsendt som oppfylte QC-kriteriene

24. september 2009

Først lagt ut (Anslag)

25. september 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. september 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 14295 (Annen identifikator: City of Hope Medical Center)
  • 2009-012007-25 (EudraCT-nummer)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

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