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GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

9 de marzo de 2018 actualizado por: GlaxoSmithKline

A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

322

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
      • Berlin, Alemania, 10117
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Alemania, 69120
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Alemania, 68167
        • GSK Investigational Site
      • Tuebingen, Baden-Wuerttemberg, Alemania, 72076
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Alemania, 80804
        • GSK Investigational Site
      • Wuerzburg, Bayern, Alemania, 97080
        • GSK Investigational Site
    • Niedersachsen
      • Buxtehude, Niedersachsen, Alemania, 21614
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Alemania, 45122
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Alemania, 01307
        • GSK Investigational Site
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Alemania, 23538
        • GSK Investigational Site
  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1121ABE
        • GSK Investigational Site
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2606
        • GSK Investigational Site
    • New South Wales
      • Port Macquarie, New South Wales, Australia, 2444
        • GSK Investigational Site
      • Waratah, New South Wales, Australia, 2300
        • GSK Investigational Site
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • GSK Investigational Site
      • Townsville, Queensland, Australia, 4810
        • GSK Investigational Site
      • Woolloongabba, Queensland, Australia, 4102
        • GSK Investigational Site
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • GSK Investigational Site
      • Woodville, South Australia, Australia, 5011
        • GSK Investigational Site
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
  • Austria
      • Graz, Austria, 8036
        • GSK Investigational Site
      • Wien, Austria, 1090
        • GSK Investigational Site
  • Bélgica
      • Brussels, Bélgica, 1200
        • GSK Investigational Site
      • Charleroi, Bélgica, 6000
        • GSK Investigational Site
      • Gent, Bélgica, 9000
        • GSK Investigational Site
      • Jette, Bélgica, 1090
        • GSK Investigational Site
      • Kortrijk, Bélgica, 8500
        • GSK Investigational Site
      • Leuven, Bélgica, 3000
        • GSK Investigational Site
      • Wilrijk, Bélgica, 2610
        • GSK Investigational Site
      • Yvoir, Bélgica, 5530
        • GSK Investigational Site
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4N2
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 4E6
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 2Y9
        • GSK Investigational Site
    • Ontario
      • Hamilton, Ontario, Canadá, L8V 5C2
        • GSK Investigational Site
      • London, Ontario, Canadá, N6A 4L6
        • GSK Investigational Site
      • Oshawa, Ontario, Canadá, L1G 2B9
        • GSK Investigational Site
      • Ottawa, Ontario, Canadá, K1H 8L6
        • GSK Investigational Site
      • Toronto, Ontario, Canadá, M5G 2M9
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canadá, H2L 4M1
        • GSK Investigational Site
      • Montreal, Quebec, Canadá, H2W 1S6
        • GSK Investigational Site
  • Chequia
      • Hradec Kralove, Chequia, 500 05
        • GSK Investigational Site
      • Ostrava, Chequia, 708 52
        • GSK Investigational Site
      • Praha 2, Chequia, 128 08
        • GSK Investigational Site
      • Zlin, Chequia, 76275
        • GSK Investigational Site
  • Estados Unidos
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85724-5024
        • GSK Investigational Site
    • Florida
      • Fort Myers, Florida, Estados Unidos, 33916
        • GSK Investigational Site
    • Georgia
      • Athens, Georgia, Estados Unidos, 30607
        • GSK Investigational Site
      • Marietta, Georgia, Estados Unidos, 30060
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • GSK Investigational Site
    • Louisiana
      • Metairie, Louisiana, Estados Unidos, 70006
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • GSK Investigational Site
    • New Jersey
      • Morristown, New Jersey, Estados Unidos, 07962-1956
        • GSK Investigational Site
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, Estados Unidos, 29210
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37404
        • GSK Investigational Site
      • Memphis, Tennessee, Estados Unidos, 38120
        • GSK Investigational Site
      • Nashville, Tennessee, Estados Unidos, 37203
        • GSK Investigational Site
  • Federación Rusa
      • Chelyabinsk, Federación Rusa, 454087
        • GSK Investigational Site
      • Magnitogorsk, Federación Rusa, 455001
        • GSK Investigational Site
      • Moscow, Federación Rusa, 115478
        • GSK Investigational Site
      • St. Petersburg, Federación Rusa, 197758
        • GSK Investigational Site
  • Francia
      • Boulogne-Billancourt, Francia, 92100
        • GSK Investigational Site
      • Grenoble, Francia, 38043
        • GSK Investigational Site
      • Montpellier, Francia, 34295
        • GSK Investigational Site
      • Nantes, Francia, 44093
        • GSK Investigational Site
      • Paris Cedex 10, Francia, 75475
        • GSK Investigational Site
      • Pierre-Benite cedex, Francia, 69495
        • GSK Investigational Site
      • Rennes, Francia, 35042
        • GSK Investigational Site
      • Tours, Francia, 37044
        • GSK Investigational Site
      • Villejuif, Francia, 94805
        • GSK Investigational Site
  • Grecia
      • Athens, Grecia, 11527
        • GSK Investigational Site
      • Athens, Grecia, 185 47
        • GSK Investigational Site
      • Thessaloniki, Grecia, 564 29
        • GSK Investigational Site
  • Italia
    • Lombardia
      • Milano, Lombardia, Italia, 20132
        • GSK Investigational Site
      • Milano, Lombardia, Italia, 20133
        • GSK Investigational Site
      • Milano, Lombardia, Italia, 20141
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italia, 56126
        • GSK Investigational Site
  • Noruega
      • Oslo, Noruega, 0310
        • GSK Investigational Site
  • Nueva Zelanda
      • Christchurch, Nueva Zelanda, 8011
        • GSK Investigational Site
      • Dunedin, Nueva Zelanda, 9016
        • GSK Investigational Site
      • Newtown, Wellington, Nueva Zelanda, 6002
        • GSK Investigational Site
  • Polonia
      • Poznan, Polonia, 61-866
        • GSK Investigational Site
      • Warszawa, Polonia, 02-781
        • GSK Investigational Site
      • Warszawa, Polonia, 04-125
        • GSK Investigational Site
  • Reino Unido
      • Aberdeen, Reino Unido, AB25 2ZN
        • GSK Investigational Site
      • Birmingham, Reino Unido, B15 2TH
        • GSK Investigational Site
      • Chelmsford, Reino Unido, CM1 7ET
        • GSK Investigational Site
      • Leeds, Reino Unido, LS9 7TF
        • GSK Investigational Site
      • London, Reino Unido, SW3 6JJ
        • GSK Investigational Site
      • London, Reino Unido, W1G 6AD
        • GSK Investigational Site
      • Manchester, Reino Unido, M20 4BX
        • GSK Investigational Site
      • Oxford, Reino Unido, OX3 7LJ
        • GSK Investigational Site
      • Southampton, Reino Unido, SO16 6YD
        • GSK Investigational Site
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Reino Unido, CB2 2QQ
        • GSK Investigational Site
    • Middlesex
      • Northwood, Middlesex, Reino Unido, HA6 2RN
        • GSK Investigational Site
    • Surrey
      • Sutton, Surrey, Reino Unido, SM2 5PT
        • GSK Investigational Site
  • Suecia
      • Goteborg, Suecia, SE-413 45
        • GSK Investigational Site
      • Linkoping, Suecia, SE-581 85
        • GSK Investigational Site
      • Lund, Suecia, SE-221 85
        • GSK Investigational Site
      • Stockholm, Suecia, SE-171 76
        • GSK Investigational Site
      • Uppsala, Suecia, SE-751 85
        • GSK Investigational Site
  • Suiza
      • Zurich, Suiza, 8091
        • GSK Investigational Site
  • Ucrania
      • Dnepropetrovsk, Ucrania, 49102
        • GSK Investigational Site
      • Kharkiv, Ucrania, 61070
        • GSK Investigational Site
      • Kyiv, Ucrania, 03022
        • GSK Investigational Site
      • Kyiv, Ucrania, 03115
        • GSK Investigational Site
      • Lviv, Ucrania, 79031
        • GSK Investigational Site
      • Sumy, Ucrania, 40005
        • GSK Investigational Site
      • Sympheropol, Ucrania, 95023
        • GSK Investigational Site
      • Ternopil, Ucrania, 46023
        • GSK Investigational Site
      • Uzhgorod, Ucrania, 88017
        • GSK Investigational Site

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:

  • ≥18 years of age
  • Stage III unresectable (Stage IIIc) or metastatic (Stage IV) cutaneous melanoma which is also determined to be BRAF V600E/K mutation-positive by the central laboratory
  • Received no prior treatment or up to one prior regimen of chemotherapy for advanced or metastatic melanoma. Prior treatment with immunotherapy (with the exception of prior ipilimumab, which is only allowed if given in the adjuvant setting), cytokine therapy, biological or vaccine regimen is permitted. Prior use of sorafenib is allowed
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  • Women of childbearing potential and men with reproductive potential must agree to use effective contraception during the study. Additionally women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Adequate screening organ function

Exclusion Criteria:

  • Any prior use of BRAF inhibitors or MEK inhibitors.
  • Subjects who have received dacarbazine or paclitaxel prior to randomization will not be eligible to receive the same chemotherapy as study medication (i.e. a subject who received prior dacarbazine cannot receive dacarbazine on this trial and would thus receive paclitaxel if randomized to the control arm)
  • History of another malignancy. Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled. Consult GSK Medical Monitor if unsure whether second malignancies meet requirements specified above
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which will be allowed)
  • Brain metastases with the following exceptions that are ALL confirmed by the GSK Medical Monitor:

All known lesions must be previously treated with surgery or stereotactic radiosurgery, and Brain lesion(s), if still present, must be confirmed stable (i.e. no increase in lesion size) for ≥90 days prior to randomization (must be documented with two consecutive MRI or CT scans using contrast), and asymptomatic with no corticosteroids requirement for ≥ 30 days prior to randomization, and no enzyme-inducing anticonvulsants for ≥ 30 days prior to randomization

  • History or evidence of cardiovascular risk including any of the following:

    • QTcB ≥ 480 msec.
    • History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for >30 days prior to randomization are eligible
    • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
    • History or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association
  • History of interstitial lung disease or pneumonitis

  • History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):

    • History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes).
    • Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
  • Evidence of new optic disc cupping.
  • Intraocular pressure > 21 mm Hg as measured by tonography

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 cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: GSK1120212
MEK inhibitor
Droga: GSK1120212
Inhibidor de MEK
Comparador activo: Chemotherapy
Investigator Choice of DTIC or paclitaxel
Droga: Chemotherapy
Investigator Choice of DTIC or paclitaxel
Experimental: Crossover
MEK inhibitor after documented progression on Chemotherapy Arm
Droga: GSK1120212
Inhibidor de MEK

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression (PD) or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Primary Efficacy Population included all participants with BRAF V600E mutation-positive melanoma without a history of brain metastases.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival in All Participants
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed and BRIC-assessed PFS were summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Intend-To-Treat (ITT) Population included all randomized participants regardless of whether or not treatment was administered.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and Without Prior Chemotherapy as Assessed by the Investigator
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and With Prior Chemotherapy as Assessed by the Investigator
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
Overall Survival in All Participants
Periodo de tiempo: Day 1 until death due to any cause (average of 20.3 months)
Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
Day 1 until death due to any cause (average of 20.3 months)
Overall Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases
Periodo de tiempo: Day 1 until death due to any cause (average of 20.3 months)
Overall survival was defined as the time from the date of randomization to the date of death due to any cause. NA indicates data was not available.
Day 1 until death due to any cause (average of 20.3 months)
Number of BRAF V600E Mutation-positive Participants Without a History of Brain Metastases With Overall Response (OR) as Assessed by the Investigator and Independent Review
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
OR is defined as the number of participants with evidence of complete response (CR; disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
Number of Participants With OR as Assessed by the Investigator and Independent Review
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
OR is defined as the number of participants with evidence of complete response (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
Number of BRAF V600E Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
OR is defined as the number of participants with evidence of complete response (disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
Number of BRAF V600K Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
OR is defined as the number of participants with evidence of complete response (CR; disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
Number of Participants With OR Following Cross-over to Trametinib
Periodo de tiempo: Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
OR is defined as the number of participants with evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator in participants following cross-over to Trametinib. The evaluation was carried out by the Investigator per RECIST, Version 1.1. Cross-over Population included the subset of participants who were randomized to CT and who elected to cross-over to Trametinib following disease progression on CT. Only participants who received at least one dose of Trametinib were included in this population.
Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
Duration of Response (DoR) for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classified as Confirmed Responders (CR or PR) as Assessed by the Investigator Review
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause. DoR for the investigator-assessed (INVA) response data were summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
DoR for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classified as Confirmed Responders (CR or PR) as Assessed by the Independent Review
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause. DoR for the independently-assessed (INDA) response data were summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
DoR for All Confirmed Responders (CR or PR) as Assessed by the Investigator Review
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR for the INVA response data was summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
DoR for All Confirmed Responders (CR or PR) as Assessed by the Independent Review
Periodo de tiempo: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR for the INDA response data was summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
DoR for All Responders (CR or PR) Following Cross-over to Trametinib as Assessed by the Investigator
Periodo de tiempo: Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
DoR is defined as the time from the first documented evidence of CR (disappearance of all extra nodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR data were summarized per RECIST, Version 1.1Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.
Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
PFS Following Cross-over to Trametinib as Assessed by the Investigator
Periodo de tiempo: Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
PFS is defined as the time from the first dose of cross-over therapy to the first documented occurrence of PD or death. PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)

Colaboradores e Investigadores

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

Patrocinador

GlaxoSmithKline

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

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)

22 de noviembre de 2010

Finalización primaria (Actual)

26 de octubre de 2011

Finalización del estudio (Actual)

16 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

18 de noviembre de 2010

Primero enviado que cumplió con los criterios de control de calidad

18 de noviembre de 2010

Publicado por primera vez (Estimar)

22 de noviembre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de abril de 2018

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

9 de marzo de 2018

Última verificación

1 de enero de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 114267

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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