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

2018年3月9日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

322

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Arizona
      • Tucson、Arizona、アメリカ、85724-5024
        • GSK Investigational Site
    • Florida
      • Fort Myers、Florida、アメリカ、33916
        • GSK Investigational Site
    • Georgia
      • Athens、Georgia、アメリカ、30607
        • GSK Investigational Site
      • Marietta、Georgia、アメリカ、30060
        • GSK Investigational Site
    • Iowa
      • Iowa City、Iowa、アメリカ、52242
        • GSK Investigational Site
    • Louisiana
      • Metairie、Louisiana、アメリカ、70006
        • GSK Investigational Site
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • GSK Investigational Site
    • New Jersey
      • Morristown、New Jersey、アメリカ、07962-1956
        • GSK Investigational Site
    • Ohio
      • Columbus、Ohio、アメリカ、43210
        • GSK Investigational Site
    • South Carolina
      • Columbia、South Carolina、アメリカ、29210
        • GSK Investigational Site
    • Tennessee
      • Chattanooga、Tennessee、アメリカ、37404
        • GSK Investigational Site
      • Memphis、Tennessee、アメリカ、38120
        • GSK Investigational Site
      • Nashville、Tennessee、アメリカ、37203
        • GSK Investigational Site
  • アルゼンチン
      • Ciudad Autonoma de Buenos Aires、アルゼンチン、C1121ABE
        • GSK Investigational Site
  • イギリス
      • Aberdeen、イギリス、AB25 2ZN
        • GSK Investigational Site
      • Birmingham、イギリス、B15 2TH
        • GSK Investigational Site
      • Chelmsford、イギリス、CM1 7ET
        • GSK Investigational Site
      • Leeds、イギリス、LS9 7TF
        • GSK Investigational Site
      • London、イギリス、SW3 6JJ
        • GSK Investigational Site
      • London、イギリス、W1G 6AD
        • GSK Investigational Site
      • Manchester、イギリス、M20 4BX
        • GSK Investigational Site
      • Oxford、イギリス、OX3 7LJ
        • GSK Investigational Site
      • Southampton、イギリス、SO16 6YD
        • GSK Investigational Site
    • Cambridgeshire
      • Cambridge、Cambridgeshire、イギリス、CB2 2QQ
        • GSK Investigational Site
    • Middlesex
      • Northwood、Middlesex、イギリス、HA6 2RN
        • GSK Investigational Site
    • Surrey
      • Sutton、Surrey、イギリス、SM2 5PT
        • GSK Investigational Site
  • イタリア
    • Lombardia
      • Milano、Lombardia、イタリア、20132
        • GSK Investigational Site
      • Milano、Lombardia、イタリア、20133
        • GSK Investigational Site
      • Milano、Lombardia、イタリア、20141
        • GSK Investigational Site
    • Toscana
      • Pisa、Toscana、イタリア、56126
        • GSK Investigational Site
  • ウクライナ
      • Dnepropetrovsk、ウクライナ、49102
        • GSK Investigational Site
      • Kharkiv、ウクライナ、61070
        • GSK Investigational Site
      • Kyiv、ウクライナ、03022
        • GSK Investigational Site
      • Kyiv、ウクライナ、03115
        • GSK Investigational Site
      • Lviv、ウクライナ、79031
        • GSK Investigational Site
      • Sumy、ウクライナ、40005
        • GSK Investigational Site
      • Sympheropol、ウクライナ、95023
        • GSK Investigational Site
      • Ternopil、ウクライナ、46023
        • GSK Investigational Site
      • Uzhgorod、ウクライナ、88017
        • GSK Investigational Site
  • オーストラリア
    • Australian Capital Territory
      • Garran、Australian Capital Territory、オーストラリア、2606
        • GSK Investigational Site
    • New South Wales
      • Port Macquarie、New South Wales、オーストラリア、2444
        • GSK Investigational Site
      • Waratah、New South Wales、オーストラリア、2300
        • GSK Investigational Site
    • Queensland
      • South Brisbane、Queensland、オーストラリア、4101
        • GSK Investigational Site
      • Townsville、Queensland、オーストラリア、4810
        • GSK Investigational Site
      • Woolloongabba、Queensland、オーストラリア、4102
        • GSK Investigational Site
    • South Australia
      • Kurralta Park、South Australia、オーストラリア、5037
        • GSK Investigational Site
      • Woodville、South Australia、オーストラリア、5011
        • GSK Investigational Site
    • Victoria
      • Heidelberg、Victoria、オーストラリア、3084
        • GSK Investigational Site
      • Melbourne、Victoria、オーストラリア、3004
        • GSK Investigational Site
  • オーストリア
      • Graz、オーストリア、8036
        • GSK Investigational Site
      • Wien、オーストリア、1090
        • GSK Investigational Site
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T2N 4N2
        • GSK Investigational Site
    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 4E6
        • GSK Investigational Site
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3H 2Y9
        • GSK Investigational Site
    • Ontario
      • Hamilton、Ontario、カナダ、L8V 5C2
        • GSK Investigational Site
      • London、Ontario、カナダ、N6A 4L6
        • GSK Investigational Site
      • Oshawa、Ontario、カナダ、L1G 2B9
        • GSK Investigational Site
      • Ottawa、Ontario、カナダ、K1H 8L6
        • GSK Investigational Site
      • Toronto、Ontario、カナダ、M5G 2M9
        • GSK Investigational Site
    • Quebec
      • Montreal、Quebec、カナダ、H2L 4M1
        • GSK Investigational Site
      • Montreal、Quebec、カナダ、H2W 1S6
        • GSK Investigational Site
  • ギリシャ
      • Athens、ギリシャ、11527
        • GSK Investigational Site
      • Athens、ギリシャ、185 47
        • GSK Investigational Site
      • Thessaloniki、ギリシャ、564 29
        • GSK Investigational Site
  • スイス
      • Zurich、スイス、8091
        • GSK Investigational Site
  • スウェーデン
      • Goteborg、スウェーデン、SE-413 45
        • GSK Investigational Site
      • Linkoping、スウェーデン、SE-581 85
        • GSK Investigational Site
      • Lund、スウェーデン、SE-221 85
        • GSK Investigational Site
      • Stockholm、スウェーデン、SE-171 76
        • GSK Investigational Site
      • Uppsala、スウェーデン、SE-751 85
        • GSK Investigational Site
  • チェコ
      • Hradec Kralove、チェコ、500 05
        • GSK Investigational Site
      • Ostrava、チェコ、708 52
        • GSK Investigational Site
      • Praha 2、チェコ、128 08
        • GSK Investigational Site
      • Zlin、チェコ、76275
        • GSK Investigational Site
  • ドイツ
      • Berlin、ドイツ、10117
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Heidelberg、Baden-Wuerttemberg、ドイツ、69120
        • GSK Investigational Site
      • Mannheim、Baden-Wuerttemberg、ドイツ、68167
        • GSK Investigational Site
      • Tuebingen、Baden-Wuerttemberg、ドイツ、72076
        • GSK Investigational Site
    • Bayern
      • Muenchen、Bayern、ドイツ、80804
        • GSK Investigational Site
      • Wuerzburg、Bayern、ドイツ、97080
        • GSK Investigational Site
    • Niedersachsen
      • Buxtehude、Niedersachsen、ドイツ、21614
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen、Nordrhein-Westfalen、ドイツ、45122
        • GSK Investigational Site
    • Sachsen
      • Dresden、Sachsen、ドイツ、01307
        • GSK Investigational Site
    • Schleswig-Holstein
      • Luebeck、Schleswig-Holstein、ドイツ、23538
        • GSK Investigational Site
  • ニュージーランド
      • Christchurch、ニュージーランド、8011
        • GSK Investigational Site
      • Dunedin、ニュージーランド、9016
        • GSK Investigational Site
      • Newtown, Wellington、ニュージーランド、6002
        • GSK Investigational Site
  • ノルウェー
      • Oslo、ノルウェー、0310
        • GSK Investigational Site
  • フランス
      • Boulogne-Billancourt、フランス、92100
        • GSK Investigational Site
      • Grenoble、フランス、38043
        • GSK Investigational Site
      • Montpellier、フランス、34295
        • GSK Investigational Site
      • Nantes、フランス、44093
        • GSK Investigational Site
      • Paris Cedex 10、フランス、75475
        • GSK Investigational Site
      • Pierre-Benite cedex、フランス、69495
        • GSK Investigational Site
      • Rennes、フランス、35042
        • GSK Investigational Site
      • Tours、フランス、37044
        • GSK Investigational Site
      • Villejuif、フランス、94805
        • GSK Investigational Site
  • ベルギー
      • Brussels、ベルギー、1200
        • GSK Investigational Site
      • Charleroi、ベルギー、6000
        • GSK Investigational Site
      • Gent、ベルギー、9000
        • GSK Investigational Site
      • Jette、ベルギー、1090
        • GSK Investigational Site
      • Kortrijk、ベルギー、8500
        • GSK Investigational Site
      • Leuven、ベルギー、3000
        • GSK Investigational Site
      • Wilrijk、ベルギー、2610
        • GSK Investigational Site
      • Yvoir、ベルギー、5530
        • GSK Investigational Site
  • ポーランド
      • Poznan、ポーランド、61-866
        • GSK Investigational Site
      • Warszawa、ポーランド、02-781
        • GSK Investigational Site
      • Warszawa、ポーランド、04-125
        • GSK Investigational Site
  • ロシア連邦
      • Chelyabinsk、ロシア連邦、454087
        • GSK Investigational Site
      • Magnitogorsk、ロシア連邦、455001
        • GSK Investigational Site
      • Moscow、ロシア連邦、115478
        • GSK Investigational Site
      • St. Petersburg、ロシア連邦、197758
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：GSK1120212
MEK inhibitor
薬：GSK1120212
MEK阻害剤
アクティブコンパレータ：Chemotherapy
Investigator Choice of DTIC or paclitaxel
薬：Chemotherapy
Investigator Choice of DTIC or paclitaxel
実験的：Crossover
MEK inhibitor after documented progression on Chemotherapy Arm
薬：GSK1120212
MEK阻害剤

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression-free Survival in All Participants
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

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スポンサー

GlaxoSmithKline

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2010年11月22日

一次修了 (実際)

2011年10月26日

研究の完了 (実際)

2016年12月16日

試験登録日

最初に提出

2010年11月18日

QC基準を満たした最初の提出物

2010年11月18日

最初の投稿 (見積もり)

2010年11月22日

学習記録の更新

投稿された最後の更新 (実際)

2018年4月5日

QC基準を満たした最後の更新が送信されました

2018年3月9日

最終確認日

2018年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 114267

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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