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

15 de agosto de 2018 actualizado 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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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(either double only or double blind and open label) for reasons other than death, lost to follow-up or consent withdrawn entered long-term follow up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

Intervencionista

Inscripción (Actual)

417

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
    • Bayern
      • Erlangen, Bayern, Alemania, 91054
      • München, Bayern, Alemania, 81377
      • Würzburg, Bayern, Alemania, 97080
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Alemania, 45122
      • Köln, Nordrhein-Westfalen, Alemania, 50924
    • Sachsen
      • Leipzig, Sachsen, Alemania, 04103
  • Arabia Saudita
      • Riyadh, Arabia Saudita, 11211
  • Austria
      • Wien, Austria, 1090
  • Bulgaria
      • Sofia, Bulgaria, 1527
  • Bélgica
      • Bruxelles - Brussel, Bélgica, 1000
  • Corea, república de
      • Daejeon, Corea, república de, 301-721
      • Seoul, Corea, república de, 137-701
      • Seoul, Corea, república de, 110-744
      • Seoul, Corea, república de, 120-752
      • Seoul, Corea, república de, 135-710
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Corea, república de, 138-736
        • Asan Medical Center
  • Dinamarca
      • Odense C, Dinamarca, 5000
  • España
      • Barcelona, España, 08035
    • Madrid
      • Majadahonda, Madrid, España, 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
  • Federación Rusa
      • Obninsk, Federación Rusa, 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
  • 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
  • Japón
    • Aichi
      • Nagoya, Aichi, Japón, 466-8560
      • Nagoya, Aichi, Japón, 464-8681
    • Chiba
      • Kashiwa, Chiba, Japón, 277-8577
    • Tokyo
      • Koto-ku, Tokyo, Japón, 135-8550
  • Países Bajos
      • Groningen, Países Bajos, 9713 GZ
      • Leiden, Países Bajos, 2333 ZA
  • Polonia
      • Gliwice, Polonia, 44-101
      • Poznan, Polonia, 60-355
      • Warszawa, Polonia, 02-781
      • Warszawa, Polonia, 04-141
  • Porcelana
      • Beijing, Porcelana, 100730
      • Beijing, Porcelana, 100021
      • Chengdu, Porcelana, 610041
      • Hangzhou, Porcelana, 310022
      • Shanghai, Porcelana, 200127
      • Shanghai, Porcelana, 200030
      • Tianjin, Porcelana, 300060
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510060
  • 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
  • Suecia
      • Göteborg, Suecia, 413 45
      • Linköping, Suecia, 581 85
      • Lund, Suecia, 221 85
      • Stockholm, Suecia, 171 76

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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
Droga: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
Comparador de placebos: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Bayer

Colaboradores

Amgen

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de octubre de 2009

Finalización primaria (Actual)

31 de agosto de 2012

Finalización del estudio (Actual)

30 de agosto de 2017

Fechas de registro del estudio

Enviado por primera vez

24 de septiembre de 2009

Primero enviado que cumplió con los criterios de control de calidad

24 de septiembre de 2009

Publicado por primera vez (Estimar)

25 de septiembre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de septiembre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

15 de agosto de 2018

Última verificación

1 de agosto de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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