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

8 februari 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

704

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Dabrafenib plus Trametinib
BRAF inhibitor plus MEK inhibitor
Geneesmiddel: Dabrafenib
Dabrafenib 150 mg twice daily orally
Andere namen:
  • GSK2118436
Geneesmiddel: Trametinib
Trametinib 2 mg once daily orally
Andere namen:
  • GSK1120212
Actieve vergelijker: Vemurafenib
BRAF inhibitor
Geneesmiddel: Vemurafenib
Vemurafenib 960 mg twice daily orally
Andere namen:
  • Monotherapie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival (PFS), as Assessed by the Investigator
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 juni 2012

Primaire voltooiing (Werkelijk)

17 april 2014

Studie voltooiing (Werkelijk)

25 april 2019

Studieregistratiedata

Eerst ingediend

10 mei 2012

Eerst ingediend dat voldeed aan de QC-criteria

10 mei 2012

Eerst geplaatst (Schatting)

14 mei 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 februari 2021

Laatste update ingediend die voldeed aan QC-criteria

8 februari 2021

Laatst geverifieerd

1 februari 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 116513
  • CDRB436B2302 (Andere identificatie: Novartis)
  • 2011-006088-23 (EudraCT-nummer)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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