Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

8. februar 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

704

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dabrafenib plus Trametinib
BRAF inhibitor plus MEK inhibitor
Medicin: Dabrafenib
Dabrafenib 150 mg twice daily orally
Andre navne:
  • GSK2118436
Medicin: Trametinib
Trametinib 2 mg once daily orally
Andre navne:
  • GSK1120212
Aktiv komparator: Vemurafenib
BRAF inhibitor
Medicin: Vemurafenib
Vemurafenib 960 mg twice daily orally
Andre navne:
  • Monoterapi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS), as Assessed by the Investigator
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. juni 2012

Primær færdiggørelse (Faktiske)

17. april 2014

Studieafslutning (Faktiske)

25. april 2019

Datoer for studieregistrering

Først indsendt

10. maj 2012

Først indsendt, der opfyldte QC-kriterier

10. maj 2012

Først opslået (Skøn)

14. maj 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 116513
  • CDRB436B2302 (Anden identifikator: Novartis)
  • 2011-006088-23 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Melanom

Kliniske forsøg med Dabrafenib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Algeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner