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

8. februar 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

704

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • Australia
    • New South Wales
      • North Sydney, New South Wales, Australia, 2060
        • Novartis Investigative Site
      • Westmead, New South Wales, Australia, 2145
        • Novartis Investigative Site
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Novartis Investigative Site
      • Herston, Queensland, Australia, 4029
        • Novartis Investigative Site
      • South Brisbane, Queensland, Australia, 4101
        • Novartis Investigative Site
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Novartis Investigative Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Novartis Investigative Site
      • Melbourne, Victoria, Australia, 3004
        • Novartis Investigative Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Novartis Investigative Site
  • Belgia
      • Brasschaat, Belgia, 2930
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      • Brussel, Belgia, 1090
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      • Brussels, Belgia, 1200
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      • Gent, Belgia, 9000
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      • Kortrijk, Belgia, 8500
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      • Leuven, Belgia, 3000
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      • Namur, Belgia, 5000
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      • Wilrijk, Belgia, 2610
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  • Brasil
      • Sao Paulo - SP, Brasil, 01323-900
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    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brasil, 98700-000
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    • Santa Catarina
      • Itajai, Santa Catarina, Brasil, 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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  • Danmark
      • Arhus C, Danmark, 8000
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      • Herlev, Danmark, 2730
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      • Odense, Danmark, 5000 C
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  • Den russiske føderasjonen
      • Chelyabinsk, Den russiske føderasjonen, 454087
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      • Magnitogorsk, Den russiske føderasjonen, 455001
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      • Moscow, Den russiske føderasjonen, 115478
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      • Moscow, Den russiske føderasjonen, 143423
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      • Nizhniy Novgorod, Den russiske føderasjonen, 603081
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      • Ryazan, Den russiske føderasjonen, 390011
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      • St. Petersburg, Den russiske føderasjonen, 197758
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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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  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35243
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    • Arizona
      • Gilbert, Arizona, Forente stater, 85234
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    • California
      • Beverly Hills, California, Forente stater, 90211
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      • Vallejo, California, Forente stater, 94589
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    • Colorado
      • Aurora, Colorado, Forente stater, 80010
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    • Florida
      • Jacksonville, Florida, Forente stater, 32204
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      • Miami Beach, Florida, Forente stater, 33140
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      • Orlando, Florida, Forente stater, 32804
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    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
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    • Iowa
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    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
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      • Fridley, Minnesota, Forente stater, 55432
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      • Saint Louis, Missouri, Forente stater, 63110
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    • Nevada
      • Las Vegas, Nevada, Forente stater, 89148
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    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
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      • New Brunswick, New Jersey, Forente stater, 08901
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    • New York
      • New York, New York, Forente stater, 10029
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    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599-7600
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      • Charlotte, North Carolina, Forente stater, 28204
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      • Durham, North Carolina, Forente stater, 27710
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    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
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      • Columbus, Ohio, Forente stater, 43210
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    • Oregon
      • Bend, Oregon, Forente stater, 97701
        • Novartis Investigative Site
      • Portland, Oregon, Forente stater, 97213
        • Novartis Investigative Site
      • Portland, Oregon, Forente stater, 97239
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    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Novartis Investigative Site
      • Greenville, South Carolina, Forente stater, 29605
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    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
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    • Texas
      • Dallas, Texas, Forente stater, 75246
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    • Utah
      • Salt Lake City, Utah, Forente stater, 84106
        • Novartis Investigative Site
      • Salt Lake City, Utah, Forente stater, 84112-5550
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    • Vermont
      • Burlington, Vermont, Forente stater, 05403
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    • Virginia
      • Charlottesville, Virginia, Forente stater, 22903
        • Novartis Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Novartis Investigative Site
  • Frankrike
      • Bordeaux, Frankrike, 33075
        • Novartis Investigative Site
      • Grenoble, Frankrike, 38043
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      • Lille, Frankrike, 59037
        • Novartis Investigative Site
      • Marseille cedex 5, Frankrike, 13385
        • Novartis Investigative Site
      • Montpellier cedex 5, Frankrike, 34295
        • Novartis Investigative Site
      • Nantes, Frankrike, 44093
        • Novartis Investigative Site
      • Nice, Frankrike, 06202
        • Novartis Investigative Site
      • Paris Cedex 10, Frankrike, 75475
        • Novartis Investigative Site
      • Reims Cedex, Frankrike, 51092
        • Novartis Investigative Site
      • Rennes Cedex, Frankrike, 35042
        • Novartis Investigative Site
      • Villejuif cedex, Frankrike, 94805
        • 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
  • Italia
    • Campania
      • Napoli, Campania, Italia, 80131
        • Novartis Investigative Site
    • Lazio
      • Roma, Lazio, Italia, 00167
        • Novartis Investigative Site
    • Liguria
      • Genova, Liguria, Italia, 16132
        • Novartis Investigative Site
    • Lombardia
      • Bergamo, Lombardia, Italia, 24128
        • Novartis Investigative Site
      • Milano, Lombardia, Italia, 20133
        • Novartis Investigative Site
      • Milano, Lombardia, Italia, 20141
        • Novartis Investigative Site
    • Toscana
      • Pisa, Toscana, Italia, 56126
        • Novartis Investigative Site
    • Veneto
      • Padova, Veneto, Italia, 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
  • Nederland
      • Amsterdam, Nederland, 1066 CX
        • Novartis Investigative Site
      • Amsterdam, Nederland, 1081 HV
        • Novartis Investigative Site
      • Groningen, Nederland, 9713 GZ
        • Novartis Investigative Site
      • Leeuwarden, Nederland, 8934 AD
        • Novartis Investigative Site
      • Leiden, Nederland, 2333 ZA
        • Novartis Investigative Site
      • Rotterdam, Nederland, 3015 GD
        • 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
  • Spania
      • Barcelona, Spania, 08036
        • Novartis Investigative Site
      • Hospitalet de Llobregat, Barcelona, Spania, 08907
        • Novartis Investigative Site
      • Las Palmas De Gran Canaria, Spania, 35016
        • Novartis Investigative Site
      • Madrid, Spania, 28007
        • Novartis Investigative Site
      • Madrid, Spania, 28050
        • Novartis Investigative Site
      • Palma de Mallorca, Spania, 07010
        • Novartis Investigative Site
      • Pamplona, Spania, 31008
        • Novartis Investigative Site
      • Valencia, Spania, 46014
        • Novartis Investigative Site
      • Valencia, Spania, 46009
        • Novartis Investigative Site
  • Storbritannia
      • Cambridge, Storbritannia, CB2 0QQ
        • Novartis Investigative Site
      • Glasgow, Storbritannia, G12 0YN
        • Novartis Investigative Site
      • London, Storbritannia, NW3 2QG
        • Novartis Investigative Site
      • London, Storbritannia, SE1 7EH
        • Novartis Investigative Site
      • Manchester, Storbritannia, M20 4BX
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      • Southampton, Storbritannia, SO16 6YD
        • Novartis Investigative Site
      • Swansea, Storbritannia, SA2 8QA
        • Novartis Investigative Site
  • Sveits
      • Basel, Sveits, 4031
        • Novartis Investigative Site
      • Lausanne, Sveits, 1011
        • Novartis Investigative Site
      • Zurich, Sveits, 8091
        • Novartis Investigative Site
  • Sverige
      • Linkoping, Sverige, SE-581 85
        • Novartis Investigative Site
      • Umea, Sverige, SE-901 85
        • Novartis Investigative Site
  • Taiwan
      • Tainan, Taiwan, 704
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      • Taipei, Taiwan, 100
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 333
        • Novartis Investigative Site
  • Tsjekkia
      • Olomouc, Tsjekkia, 775 20
        • Novartis Investigative Site
      • Ostrava, Tsjekkia, 708 52
        • Novartis Investigative Site
      • Praha 10, Tsjekkia, 100 34
        • Novartis Investigative Site
      • Praha 2, Tsjekkia, 128 08
        • Novartis Investigative Site
      • Zlin, Tsjekkia, 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
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      • Muenchen, Bayern, Tyskland, 80802
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      • Nuernberg, Bayern, Tyskland, 90419
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      • Regensburg, Bayern, Tyskland, 93053
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      • Wuerzburg, Bayern, Tyskland, 97080
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    • Niedersachsen
      • Buxtehude, Niedersachsen, Tyskland, 21614
        • Novartis Investigative Site
      • Hannover, Niedersachsen, Tyskland, 30625
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    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Tyskland, 53127
        • Novartis Investigative Site
      • Essen, Nordrhein-Westfalen, Tyskland, 45122
        • Novartis Investigative Site
      • Koeln, Nordrhein-Westfalen, Tyskland, 50937
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    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Tyskland, 67063
        • Novartis Investigative Site
      • Mainz, Rheinland-Pfalz, Tyskland, 55131
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    • Sachsen
      • Dresden, Sachsen, Tyskland, 01307
        • Novartis Investigative Site
      • Leipzig, Sachsen, Tyskland, 04103
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    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Tyskland, 39120
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    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Tyskland, 24105
        • Novartis Investigative Site
      • Luebeck, Schleswig-Holstein, Tyskland, 23538
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    • Thueringen
      • Erfurt, Thueringen, Tyskland, 99089
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      • Gera, Thueringen, Tyskland, 07548
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  • Ukraina
      • Dnipropetrovsk, Ukraina, 49102
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      • Donetsk, Ukraina, 83092
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      • Kharkiv, Ukraina, 61070
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      • Kyiv, Ukraina, 03022
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      • Lviv, Ukraina, 79031
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      • Sumy, Ukraina, 40005
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      • Uzhgorod, Ukraina, 88017
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  • Ungarn
      • Budapest, Ungarn, H-1122
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      • Debrecen, Ungarn, 4032
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      • Kaposvar, Ungarn, 7400
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  • Østerrike
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Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dabrafenib plus Trametinib
BRAF inhibitor plus MEK inhibitor
Legemiddel: Dabrafenib
Dabrafenib 150 mg twice daily orally
Andre navn:
  • GSK2118436
Legemiddel: Trametinib
Trametinib 2 mg once daily orally
Andre navn:
  • GSK1120212
Aktiv komparator: Vemurafenib
BRAF inhibitor
Legemiddel: Vemurafenib
Vemurafenib 960 mg twice daily orally
Andre navn:
  • Monoterapi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. juni 2012

Primær fullføring (Faktiske)

17. april 2014

Studiet fullført (Faktiske)

25. april 2019

Datoer for studieregistrering

Først innsendt

10. mai 2012

Først innsendt som oppfylte QC-kriteriene

10. mai 2012

Først lagt ut (Anslag)

14. mai 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. februar 2021

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Kyrgyzstan

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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