Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

15 de agosto de 2018 atualizado por: 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

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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(either double only or double blind and open label) for reasons other than death, lost to follow-up or consent withdrawn entered long-term follow up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

Intervencional

Inscrição (Real)

417

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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
Medicamento: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
Comparador de Placebo: Placebo
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
Medicamento: Placebo
Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival (OS)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Bayer

Colaboradores

Amgen

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de outubro de 2009

Conclusão Primária (Real)

31 de agosto de 2012

Conclusão do estudo (Real)

30 de agosto de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

24 de setembro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de setembro de 2009

Primeira postagem (Estimativa)

25 de setembro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de setembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de agosto de 2018

Última verificação

1 de agosto de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 14295 (Outro identificador: City of Hope Medical Center)
  • 2009-012007-25 (Número EudraCT)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever