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

15 agosto 2018 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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(either double only or double blind and open label) for reasons other than death, lost to follow-up or consent withdrawn entered long-term follow up

Tipo di studio

Interventistico

Iscrizione (Effettivo)

417

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Arabia Saudita
      • Riyadh, Arabia Saudita, 11211
  • Austria
      • Wien, Austria, 1090
  • Belgio
      • Bruxelles - Brussel, Belgio, 1000
  • Bulgaria
      • Sofia, Bulgaria, 1527
  • Cina
      • Beijing, Cina, 100730
      • Beijing, Cina, 100021
      • Chengdu, Cina, 610041
      • Hangzhou, Cina, 310022
      • Shanghai, Cina, 200127
      • Shanghai, Cina, 200030
      • Tianjin, Cina, 300060
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510060
  • Corea, Repubblica di
      • Daejeon, Corea, Repubblica di, 301-721
      • Seoul, Corea, Repubblica di, 137-701
      • Seoul, Corea, Repubblica di, 110-744
      • Seoul, Corea, Repubblica di, 120-752
      • Seoul, Corea, Repubblica di, 135-710
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Corea, Repubblica di, 138-736
        • Asan Medical Center
  • Danimarca
      • Odense C, Danimarca, 5000
  • Federazione Russa
      • Obninsk, Federazione Russa, 249036
  • Francia
      • Angers, Francia, 49933
      • Bordeaux, Francia, 33076
      • Caen, Francia, 14076
      • LILLE cedex, Francia, 59037
      • Lyon, Francia, 69373
      • MARSEILLE cedex, Francia, 13273
      • Paris, Francia, 75651
      • Villejuif, Francia, 94805
  • Germania
    • Bayern
      • Erlangen, Bayern, Germania, 91054
      • München, Bayern, Germania, 81377
      • Würzburg, Bayern, Germania, 97080
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germania, 45122
      • Köln, Nordrhein-Westfalen, Germania, 50924
    • Sachsen
      • Leipzig, Sachsen, Germania, 04103
  • Giappone
    • Aichi
      • Nagoya, Aichi, Giappone, 466-8560
      • Nagoya, Aichi, Giappone, 464-8681
    • Chiba
      • Kashiwa, Chiba, Giappone, 277-8577
    • Tokyo
      • Koto-ku, Tokyo, Giappone, 135-8550
  • 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
  • Olanda
      • Groningen, Olanda, 9713 GZ
      • Leiden, Olanda, 2333 ZA
  • Polonia
      • Gliwice, Polonia, 44-101
      • Poznan, Polonia, 60-355
      • Warszawa, Polonia, 02-781
      • Warszawa, Polonia, 04-141
  • Regno Unito
      • Cardiff, Regno Unito, CF14 2TL
      • Glasgow, Regno Unito, G12 0YN
      • Leeds, Regno Unito, LS9 7TF
      • London, Regno Unito, SE1 9RT
      • London, Regno Unito, SM2 5PT
      • Manchester, Regno Unito, M20 4BX
      • Newcastle Upon Tyne, Regno Unito, NE7 7DN
      • Sutton, Regno Unito, SM2 5PT
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, Regno Unito, AB25 2ZN
  • Spagna
      • Barcelona, Spagna, 08035
    • Madrid
      • Majadahonda, Madrid, Spagna, 28222
  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90048
      • Stanford, California, Stati Uniti, 94305-5820
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06520
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02118
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
    • Missouri
      • Saint Louis, Missouri, Stati Uniti, 63110
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87106
    • New York
      • New York, New York, Stati Uniti, 10029
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213-1863
    • Texas
      • Houston, Texas, Stati Uniti, 77030
    • Washington
      • Seattle, Washington, Stati Uniti, 98109-1023
  • Svezia
      • Göteborg, Svezia, 413 45
      • Linköping, Svezia, 581 85
      • Lund, Svezia, 221 85
      • Stockholm, Svezia, 171 76

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
Comparatore placebo: Placebo
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
Droga: Placebo
Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bayer

Collaboratori

Amgen

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 ottobre 2009

Completamento primario (Effettivo)

31 agosto 2012

Completamento dello studio (Effettivo)

30 agosto 2017

Date di iscrizione allo studio

Primo inviato

24 settembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

24 settembre 2009

Primo Inserito (Stima)

25 settembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 settembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 agosto 2018

Ultimo verificato

1 agosto 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 14295 (Altro identificatore: City of Hope Medical Center)
  • 2009-012007-25 (Numero EudraCT)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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