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Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma (COMBI-v)

2021年2月8日 更新者：Novartis Pharmaceuticals

A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Screening/Subject eligibility: Subjects with histologically confirmed cutaneous melanoma that was either unresectable or metastatic (Stages IIIC or IV), were screened for eligibility. Eligible subjects were BRAF V600E or V600K mutation positive. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed.

Randomization: A total of 704 subjects were randomized in a ratio of 1:1 to receive combination therapy (352 subjects) or vemurafenib treatment (352 subjects). Subjects were stratified by LDH level (> the ULN versus =< ULN) and BRAF mutation (V600E versus V600K).

Study treatment: Dabrafenib and trametinib were administered orally at their recommended doses of 150 mg b.i.d. and 2.0 mg once daily, respectively. Subjects randomized in the combination therapy arm received both the agents. Subjects randomized in the vemurafenib arm received vemurafenib at the recommended dose of 960 mg orally b.i.d. Subjects in both the arms continued treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent. The protocol was amended on 07-Aug-2014 which allowed subjects who were still receiving vemurafenib to cross over to the dabrafenib and trametinib combination arm, including those subjects who were still receiving vemurafenib monotherapy treatment after disease progression. A washout period of a minimum of 7 days was considered prior to initiating dabrafenib in combination with trametinib. Subjects who experienced disease progression on the vemurafenib monotherapy arm, discontinued vemurafenib monotherapy, and subsequently received another anticancer therapy were ineligible for cross over to the dabrafenib and trametinib combination arm.

Follow-up/Study closure: After study treatment discontinuation, subjects were followed for survival and disease progression as applicable. This study completed once all the subjects had at least the 5-years of follow-up.

研究类型

介入性

注册 (实际的)

704

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Arhus C、丹麦、8000
        • Novartis Investigative Site
      • Herlev、丹麦、2730
        • Novartis Investigative Site
      • Odense、丹麦、5000 C
        • Novartis Investigative Site
  • 乌克兰
      • Dnipropetrovsk、乌克兰、49102
        • Novartis Investigative Site
      • Donetsk、乌克兰、83092
        • Novartis Investigative Site
      • Kharkiv、乌克兰、61070
        • Novartis Investigative Site
      • Kyiv、乌克兰、03022
        • Novartis Investigative Site
      • Lviv、乌克兰、79031
        • Novartis Investigative Site
      • Sumy、乌克兰、40005
        • Novartis Investigative Site
      • Uzhgorod、乌克兰、88017
        • Novartis Investigative Site
  • 以色列
      • Jerusalem、以色列
        • Novartis Investigative Site
      • Ramat Gan、以色列、52621
        • Novartis Investigative Site
  • 俄罗斯联邦
      • Chelyabinsk、俄罗斯联邦、454087
        • Novartis Investigative Site
      • Magnitogorsk、俄罗斯联邦、455001
        • Novartis Investigative Site
      • Moscow、俄罗斯联邦、115478
        • Novartis Investigative Site
      • Moscow、俄罗斯联邦、143423
        • Novartis Investigative Site
      • Nizhniy Novgorod、俄罗斯联邦、603081
        • Novartis Investigative Site
      • Ryazan、俄罗斯联邦、390011
        • Novartis Investigative Site
      • St. Petersburg、俄罗斯联邦、197758
        • Novartis Investigative Site
  • 加拿大
      • Quebec、加拿大、G1R 2J6
        • Novartis Investigative Site
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N2
        • Novartis Investigative Site
    • British Columbia
      • Kelowna、British Columbia、加拿大、V1Y 5L3
        • Novartis Investigative Site
      • Vancouver、British Columbia、加拿大、V5Z 4E6
        • Novartis Investigative Site
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3E 0V9
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 2Y9
        • Novartis Investigative Site
    • Ontario
      • Kingston、Ontario、加拿大、K7L 5P9
        • Novartis Investigative Site
      • Oshawa、Ontario、加拿大、L1G 2B9
        • Novartis Investigative Site
      • Ottawa、Ontario、加拿大、K1H 8L6
        • Novartis Investigative Site
      • Toronto、Ontario、加拿大、M5G 2M9
        • Novartis Investigative Site
      • Toronto、Ontario、加拿大、M4N 3M5
        • Novartis Investigative Site
    • Quebec
      • Montreal、Quebec、加拿大、H2L 4M1
        • Novartis Investigative Site
  • 匈牙利
      • Budapest、匈牙利、H-1122
        • Novartis Investigative Site
      • Budapest、匈牙利、1062
        • Novartis Investigative Site
      • Debrecen、匈牙利、4032
        • Novartis Investigative Site
      • Gyor、匈牙利、H-9024
        • Novartis Investigative Site
      • Kaposvar、匈牙利、7400
        • Novartis Investigative Site
      • Miskolc、匈牙利、3526
        • Novartis Investigative Site
      • Szeged、匈牙利、6720
        • Novartis Investigative Site
  • 台湾
      • Tainan、台湾、704
        • Novartis Investigative Site
      • Taipei、台湾、100
        • Novartis Investigative Site
      • Taoyuan、台湾、333
        • Novartis Investigative Site
  • 大韩民国
      • Goyang-si, Gyeonggi-Do、大韩民国、410-769
        • Novartis Investigative Site
      • Seoul、大韩民国、03080
        • Novartis Investigative Site
      • Seoul、大韩民国、135-710
        • Novartis Investigative Site
  • 奥地利
      • Graz、奥地利、A-8036
        • Novartis Investigative Site
      • Innsbruck、奥地利、6020
        • Novartis Investigative Site
      • Salzburg、奥地利、A-5020
        • Novartis Investigative Site
      • Wien、奥地利、1090
        • Novartis Investigative Site
      • Wien、奥地利、A-1030
        • Novartis Investigative Site
  • 巴西
      • Sao Paulo - SP、巴西、01323-900
        • Novartis Investigative Site
    • Rio Grande Do Sul
      • Ijui、Rio Grande Do Sul、巴西、98700-000
        • Novartis Investigative Site
    • Santa Catarina
      • Itajai、Santa Catarina、巴西、88301-215
        • Novartis Investigative Site
  • 德国
    • Baden-Wuerttemberg
      • Heidelberg、Baden-Wuerttemberg、德国、69120
        • Novartis Investigative Site
      • Heilbronn、Baden-Wuerttemberg、德国、74078
        • Novartis Investigative Site
      • Mannheim、Baden-Wuerttemberg、德国、68167
        • Novartis Investigative Site
      • Tuebingen、Baden-Wuerttemberg、德国、72076
        • Novartis Investigative Site
    • Bayern
      • Erlangen、Bayern、德国、91054
        • Novartis Investigative Site
      • Muenchen、Bayern、德国、80337
        • Novartis Investigative Site
      • Muenchen、Bayern、德国、80804
        • Novartis Investigative Site
      • Muenchen、Bayern、德国、80802
        • Novartis Investigative Site
      • Nuernberg、Bayern、德国、90419
        • Novartis Investigative Site
      • Regensburg、Bayern、德国、93053
        • Novartis Investigative Site
      • Wuerzburg、Bayern、德国、97080
        • Novartis Investigative Site
    • Niedersachsen
      • Buxtehude、Niedersachsen、德国、21614
        • Novartis Investigative Site
      • Hannover、Niedersachsen、德国、30625
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Bonn、Nordrhein-Westfalen、德国、53127
        • Novartis Investigative Site
      • Essen、Nordrhein-Westfalen、德国、45122
        • Novartis Investigative Site
      • Koeln、Nordrhein-Westfalen、德国、50937
        • Novartis Investigative Site
    • Rheinland-Pfalz
      • Ludwigshafen、Rheinland-Pfalz、德国、67063
        • Novartis Investigative Site
      • Mainz、Rheinland-Pfalz、德国、55131
        • Novartis Investigative Site
    • Sachsen
      • Dresden、Sachsen、德国、01307
        • Novartis Investigative Site
      • Leipzig、Sachsen、德国、04103
        • Novartis Investigative Site
    • Sachsen-Anhalt
      • Magdeburg、Sachsen-Anhalt、德国、39120
        • Novartis Investigative Site
    • Schleswig-Holstein
      • Kiel、Schleswig-Holstein、德国、24105
        • Novartis Investigative Site
      • Luebeck、Schleswig-Holstein、德国、23538
        • Novartis Investigative Site
    • Thueringen
      • Erfurt、Thueringen、德国、99089
        • Novartis Investigative Site
      • Gera、Thueringen、德国、07548
        • Novartis Investigative Site
  • 意大利
    • Campania
      • Napoli、Campania、意大利、80131
        • Novartis Investigative Site
    • Lazio
      • Roma、Lazio、意大利、00167
        • Novartis Investigative Site
    • Liguria
      • Genova、Liguria、意大利、16132
        • Novartis Investigative Site
    • Lombardia
      • Bergamo、Lombardia、意大利、24128
        • Novartis Investigative Site
      • Milano、Lombardia、意大利、20133
        • Novartis Investigative Site
      • Milano、Lombardia、意大利、20141
        • Novartis Investigative Site
    • Toscana
      • Pisa、Toscana、意大利、56126
        • Novartis Investigative Site
    • Veneto
      • Padova、Veneto、意大利、35128
        • Novartis Investigative Site
  • 挪威
      • Kristiansand、挪威、4604
        • Novartis Investigative Site
      • Lorenskog、挪威、1478
        • Novartis Investigative Site
      • Oslo、挪威、0310
        • Novartis Investigative Site
  • 捷克语
      • Olomouc、捷克语、775 20
        • Novartis Investigative Site
      • Ostrava、捷克语、708 52
        • Novartis Investigative Site
      • Praha 10、捷克语、100 34
        • Novartis Investigative Site
      • Praha 2、捷克语、128 08
        • Novartis Investigative Site
      • Zlin、捷克语、76275
        • Novartis Investigative Site
  • 新西兰
      • Christchurch、新西兰、8011
        • Novartis Investigative Site
      • Newtown, Wellington、新西兰、6002
        • Novartis Investigative Site
  • 比利时
      • Brasschaat、比利时、2930
        • Novartis Investigative Site
      • Brussel、比利时、1090
        • Novartis Investigative Site
      • Brussels、比利时、1200
        • Novartis Investigative Site
      • Gent、比利时、9000
        • Novartis Investigative Site
      • Kortrijk、比利时、8500
        • Novartis Investigative Site
      • Leuven、比利时、3000
        • Novartis Investigative Site
      • Namur、比利时、5000
        • Novartis Investigative Site
      • Wilrijk、比利时、2610
        • Novartis Investigative Site
  • 法国
      • Bordeaux、法国、33075
        • Novartis Investigative Site
      • Grenoble、法国、38043
        • Novartis Investigative Site
      • Lille、法国、59037
        • Novartis Investigative Site
      • Marseille cedex 5、法国、13385
        • Novartis Investigative Site
      • Montpellier cedex 5、法国、34295
        • Novartis Investigative Site
      • Nantes、法国、44093
        • Novartis Investigative Site
      • Nice、法国、06202
        • Novartis Investigative Site
      • Paris Cedex 10、法国、75475
        • Novartis Investigative Site
      • Reims Cedex、法国、51092
        • Novartis Investigative Site
      • Rennes Cedex、法国、35042
        • Novartis Investigative Site
      • Villejuif cedex、法国、94805
        • Novartis Investigative Site
  • 波兰
      • Gdansk、波兰、80-215
        • Novartis Investigative Site
      • Konin、波兰、62-500
        • Novartis Investigative Site
      • Poznan、波兰、60-693
        • Novartis Investigative Site
      • Warszawa、波兰、02-781
        • Novartis Investigative Site
  • 澳大利亚
    • New South Wales
      • North Sydney、New South Wales、澳大利亚、2060
        • Novartis Investigative Site
      • Westmead、New South Wales、澳大利亚、2145
        • Novartis Investigative Site
    • Queensland
      • Greenslopes、Queensland、澳大利亚、4120
        • Novartis Investigative Site
      • Herston、Queensland、澳大利亚、4029
        • Novartis Investigative Site
      • South Brisbane、Queensland、澳大利亚、4101
        • Novartis Investigative Site
    • South Australia
      • Woodville、South Australia、澳大利亚、5011
        • Novartis Investigative Site
    • Victoria
      • Box Hill、Victoria、澳大利亚、3128
        • Novartis Investigative Site
      • Melbourne、Victoria、澳大利亚、3004
        • Novartis Investigative Site
    • Western Australia
      • Nedlands、Western Australia、澳大利亚、6009
        • Novartis Investigative Site
  • 爱尔兰
      • Co.Cork、爱尔兰
        • Novartis Investigative Site
      • Dublin、爱尔兰、7
        • Novartis Investigative Site
      • Dublin、爱尔兰、9
        • Novartis Investigative Site
      • Dublin、爱尔兰、4
        • Novartis Investigative Site
      • Galway、爱尔兰
        • Novartis Investigative Site
  • 瑞典
      • Linkoping、瑞典、SE-581 85
        • Novartis Investigative Site
      • Umea、瑞典、SE-901 85
        • Novartis Investigative Site
  • 瑞士
      • Basel、瑞士、4031
        • Novartis Investigative Site
      • Lausanne、瑞士、1011
        • Novartis Investigative Site
      • Zurich、瑞士、8091
        • Novartis Investigative Site
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35243
        • Novartis Investigative Site
    • Arizona
      • Gilbert、Arizona、美国、85234
        • Novartis Investigative Site
    • California
      • Beverly Hills、California、美国、90211
        • Novartis Investigative Site
      • San Francisco、California、美国、94115
        • Novartis Investigative Site
      • Vallejo、California、美国、94589
        • Novartis Investigative Site
    • Colorado
      • Aurora、Colorado、美国、80010
        • Novartis Investigative Site
    • Florida
      • Jacksonville、Florida、美国、32204
        • Novartis Investigative Site
      • Miami Beach、Florida、美国、33140
        • Novartis Investigative Site
      • Orlando、Florida、美国、32804
        • Novartis Investigative Site
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Novartis Investigative Site
      • Atlanta、Georgia、美国、30341
        • Novartis Investigative Site
    • Iowa
      • Iowa City、Iowa、美国、52242
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • Novartis Investigative Site
    • Minnesota
      • Fridley、Minnesota、美国、55432
        • Novartis Investigative Site
    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Novartis Investigative Site
    • Nevada
      • Las Vegas、Nevada、美国、89148
        • Novartis Investigative Site
    • New Jersey
      • Hackensack、New Jersey、美国、07601
        • Novartis Investigative Site
      • New Brunswick、New Jersey、美国、08901
        • Novartis Investigative Site
    • New York
      • New York、New York、美国、10029
        • Novartis Investigative Site
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599-7600
        • Novartis Investigative Site
      • Charlotte、North Carolina、美国、28204
        • Novartis Investigative Site
      • Durham、North Carolina、美国、27710
        • Novartis Investigative Site
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • Novartis Investigative Site
      • Columbus、Ohio、美国、43210
        • Novartis Investigative Site
    • Oregon
      • Bend、Oregon、美国、97701
        • Novartis Investigative Site
      • Portland、Oregon、美国、97213
        • Novartis Investigative Site
      • Portland、Oregon、美国、97239
        • Novartis Investigative Site
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Novartis Investigative Site
      • Greenville、South Carolina、美国、29605
        • Novartis Investigative Site
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Novartis Investigative Site
    • Texas
      • Dallas、Texas、美国、75246
        • Novartis Investigative Site
    • Utah
      • Salt Lake City、Utah、美国、84106
        • Novartis Investigative Site
      • Salt Lake City、Utah、美国、84112-5550
        • Novartis Investigative Site
    • Vermont
      • Burlington、Vermont、美国、05403
        • Novartis Investigative Site
    • Virginia
      • Charlottesville、Virginia、美国、22903
        • Novartis Investigative Site
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Novartis Investigative Site
  • 芬兰
      • Helsinki、芬兰、00029
        • Novartis Investigative Site
      • Jyvaskyla、芬兰、40620
        • Novartis Investigative Site
      • Tampere、芬兰、33520
        • Novartis Investigative Site
      • Turku、芬兰、20520
        • Novartis Investigative Site
  • 英国
      • Cambridge、英国、CB2 0QQ
        • Novartis Investigative Site
      • Glasgow、英国、G12 0YN
        • Novartis Investigative Site
      • London、英国、NW3 2QG
        • Novartis Investigative Site
      • London、英国、SE1 7EH
        • Novartis Investigative Site
      • Manchester、英国、M20 4BX
        • Novartis Investigative Site
      • Southampton、英国、SO16 6YD
        • Novartis Investigative Site
      • Swansea、英国、SA2 8QA
        • Novartis Investigative Site
  • 荷兰
      • Amsterdam、荷兰、1066 CX
        • Novartis Investigative Site
      • Amsterdam、荷兰、1081 HV
        • Novartis Investigative Site
      • Groningen、荷兰、9713 GZ
        • Novartis Investigative Site
      • Leeuwarden、荷兰、8934 AD
        • Novartis Investigative Site
      • Leiden、荷兰、2333 ZA
        • Novartis Investigative Site
      • Rotterdam、荷兰、3015 GD
        • Novartis Investigative Site
  • 西班牙
      • Barcelona、西班牙、08036
        • Novartis Investigative Site
      • Hospitalet de Llobregat, Barcelona、西班牙、08907
        • Novartis Investigative Site
      • Las Palmas De Gran Canaria、西班牙、35016
        • Novartis Investigative Site
      • Madrid、西班牙、28007
        • Novartis Investigative Site
      • Madrid、西班牙、28050
        • Novartis Investigative Site
      • Palma de Mallorca、西班牙、07010
        • Novartis Investigative Site
      • Pamplona、西班牙、31008
        • Novartis Investigative Site
      • Valencia、西班牙、46014
        • Novartis Investigative Site
      • Valencia、西班牙、46009
        • Novartis Investigative Site
  • 阿根廷
      • Ciudad Autonoma de Buenos Aires、阿根廷、C1121ABE
        • Novartis Investigative Site
      • San Miguel de Tucuman、阿根廷、T4000IAK
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      • Santa Fe、阿根廷、3000
        • Novartis Investigative Site
    • Buenos Aires
      • Capital Federal、Buenos Aires、阿根廷、C1426ANZ
        • Novartis Investigative Site
    • Río Negro
      • Viedma、Río Negro、阿根廷、R8500ACE
        • Novartis Investigative Site
    • Santa Fe
      • Rosario、Santa Fe、阿根廷、S2000KZE
        • Novartis Investigative Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key Inclusion Criteria:

  • >= 18 years of age
  • Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma
  • Measurable disease according to RECIST 1.1
  • Women of childbearing potential with negative serum pregnancy test prior to randomisation
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate baseline organ function

Key Exclusion Criteria:

  • Any prior use of a BRAF or MEK inhibitor
  • Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior systemic treatment in the adjuvant setting is allowed
  • History of another malignancy (except subjects who have been disease free for 3 years or with a history of completely resected non-melanoma skin cancer)
  • Known HIV, HBV, HCV infection (except chronic or cleared HBV and HCV infection which will be allowed)
  • Brain metastases (except if all known lesions were previously treated with surgery or stereotactic radiosurgery and lesions, if still present, are confirmed stable for >= 12 weeks prior to randomisation or if no longer present are confirmed no evidence of disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for >= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4 weeks prior to randomisation
  • History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by anti-hypertensive therapy)
  • History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Dabrafenib plus Trametinib
BRAF inhibitor plus MEK inhibitor
药品：Dabrafenib
Dabrafenib 150 mg twice daily orally
其他名称：
  • GSK2118436
药品：Trametinib
Trametinib 2 mg once daily orally
其他名称：
  • GSK1120212
有源比较器：Vemurafenib
BRAF inhibitor
药品：Vemurafenib
Vemurafenib 960 mg twice daily orally
其他名称：
  • 单一疗法

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间：From the date of randomization until date of death due to any cause (up to approximately 6 years)
Overall Survival (OS) was defined as the interval of time between the date of randomization and the date of death due to any cause. For patients who did not die, OS was censored at the date of last contact.
From the date of randomization until date of death due to any cause (up to approximately 6 years)

次要结果测量

结果测量
措施说明
大体时间
Progression-Free Survival (PFS), as Assessed by the Investigator
大体时间：From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years)
Progression-free survival (PFS) was defined as the interval of time between the date of randomization and the first documented occurrence of disease progression or death due to any cause. PFS for investigator-assessed response was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression was 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.
From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years)
Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator
大体时间：From randomization until the first documented complete response or partial response (up to approximately 6 years)
Overall response was defined as the percentage of confirmed responders (complete response [CR] + partial response [PR] per RECIST, Version 1.1) as summarized by Investigator assessment. CR was defined as the disappearance of all evidence of target lesions. PR was defined as at least a 30% reduction from Baseline in the sum of the longest diameter (LD) of all target lesions. Data were reported as those participants with measureable disease at Baseline.
From randomization until the first documented complete response or partial response (up to approximately 6 years)
Duration of Response (DOR), as Assessed by the Investigator
大体时间：From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years)
Duration of Response (DOR) was defined as the time from the first documented evidence of a CR (disappearance of all evidence of target lesions) or a PR (at least a 30% reduction from Baseline in the sum of the longest diameter of all target lesions) until disease progression or death due to any cause. PD was 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 at least1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Data were summarized per RECIST, Version 1.1.
From the time of the first documented response (CR or PR) until disease progression (up to approximately 6 years)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

出版物和有用的链接

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一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年6月4日

初级完成 (实际的)

2014年4月17日

研究完成 (实际的)

2019年4月25日

研究注册日期

首次提交

2012年5月10日

首先提交符合 QC 标准的

2012年5月10日

首次发布 (估计)

2012年5月14日

研究记录更新

最后更新发布 (实际的)

2021年2月24日

上次提交的符合 QC 标准的更新

2021年2月8日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 116513
  • CDRB436B2302 (其他标识符：Novartis)
  • 2011-006088-23 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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