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

2021년 2월 8일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

704

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dabrafenib plus Trametinib
BRAF inhibitor plus MEK inhibitor
의약품: Dabrafenib
Dabrafenib 150 mg twice daily orally
다른 이름들:
  • GSK2118436
의약품: Trametinib
Trametinib 2 mg once daily orally
다른 이름들:
  • GSK1120212
활성 비교기: Vemurafenib
BRAF inhibitor
의약품: Vemurafenib
Vemurafenib 960 mg twice daily orally
다른 이름들:
  • 단일 요법

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Progression-Free Survival (PFS), as Assessed by the Investigator
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2012년 6월 4일

기본 완료 (실제)

2014년 4월 17일

연구 완료 (실제)

2019년 4월 25일

연구 등록 날짜

최초 제출

2012년 5월 10일

QC 기준을 충족하는 최초 제출

2012년 5월 10일

처음 게시됨 (추정)

2012년 5월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 2월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 2월 8일

마지막으로 확인됨

2021년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 116513
  • CDRB436B2302 (기타 식별자: Novartis)
  • 2011-006088-23 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Dabrafenib에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Moldova

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다