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

8 de febrero de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

704

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Alemania, 69120
        • Novartis Investigative Site
      • Heilbronn, Baden-Wuerttemberg, Alemania, 74078
        • Novartis Investigative Site
      • Mannheim, Baden-Wuerttemberg, Alemania, 68167
        • Novartis Investigative Site
      • Tuebingen, Baden-Wuerttemberg, Alemania, 72076
        • Novartis Investigative Site
    • Bayern
      • Erlangen, Bayern, Alemania, 91054
        • Novartis Investigative Site
      • Muenchen, Bayern, Alemania, 80337
        • Novartis Investigative Site
      • Muenchen, Bayern, Alemania, 80804
        • Novartis Investigative Site
      • Muenchen, Bayern, Alemania, 80802
        • Novartis Investigative Site
      • Nuernberg, Bayern, Alemania, 90419
        • Novartis Investigative Site
      • Regensburg, Bayern, Alemania, 93053
        • Novartis Investigative Site
      • Wuerzburg, Bayern, Alemania, 97080
        • Novartis Investigative Site
    • Niedersachsen
      • Buxtehude, Niedersachsen, Alemania, 21614
        • Novartis Investigative Site
      • Hannover, Niedersachsen, Alemania, 30625
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Alemania, 53127
        • Novartis Investigative Site
      • Essen, Nordrhein-Westfalen, Alemania, 45122
        • Novartis Investigative Site
      • Koeln, Nordrhein-Westfalen, Alemania, 50937
        • Novartis Investigative Site
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Alemania, 67063
        • Novartis Investigative Site
      • Mainz, Rheinland-Pfalz, Alemania, 55131
        • Novartis Investigative Site
    • Sachsen
      • Dresden, Sachsen, Alemania, 01307
        • Novartis Investigative Site
      • Leipzig, Sachsen, Alemania, 04103
        • Novartis Investigative Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Alemania, 39120
        • Novartis Investigative Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Alemania, 24105
        • Novartis Investigative Site
      • Luebeck, Schleswig-Holstein, Alemania, 23538
        • Novartis Investigative Site
    • Thueringen
      • Erfurt, Thueringen, Alemania, 99089
        • Novartis Investigative Site
      • Gera, Thueringen, Alemania, 07548
        • Novartis Investigative Site
  • 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
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      • Westmead, New South Wales, Australia, 2145
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    • 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
  • Austria
      • Graz, Austria, A-8036
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      • Innsbruck, Austria, 6020
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      • Salzburg, Austria, A-5020
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      • Wien, Austria, 1090
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      • Wien, Austria, A-1030
        • Novartis Investigative Site
  • 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
        • Novartis Investigative Site
  • Bélgica
      • Brasschaat, Bélgica, 2930
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      • Brussel, Bélgica, 1090
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      • Brussels, Bélgica, 1200
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      • Gent, Bélgica, 9000
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      • Kortrijk, Bélgica, 8500
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      • Leuven, Bélgica, 3000
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      • Namur, Bélgica, 5000
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      • Wilrijk, Bélgica, 2610
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  • Canadá
      • Quebec, Canadá, G1R 2J6
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    • Alberta
      • Calgary, Alberta, Canadá, T2N 4N2
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    • British Columbia
      • Kelowna, British Columbia, Canadá, V1Y 5L3
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canadá, V5Z 4E6
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    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3E 0V9
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    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 2Y9
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    • Ontario
      • Kingston, Ontario, Canadá, K7L 5P9
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      • Oshawa, Ontario, Canadá, L1G 2B9
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      • Ottawa, Ontario, Canadá, K1H 8L6
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      • Toronto, Ontario, Canadá, M5G 2M9
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      • Toronto, Ontario, Canadá, M4N 3M5
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    • Quebec
      • Montreal, Quebec, Canadá, H2L 4M1
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  • Chequia
      • Olomouc, Chequia, 775 20
        • Novartis Investigative Site
      • Ostrava, Chequia, 708 52
        • Novartis Investigative Site
      • Praha 10, Chequia, 100 34
        • Novartis Investigative Site
      • Praha 2, Chequia, 128 08
        • Novartis Investigative Site
      • Zlin, Chequia, 76275
        • Novartis Investigative Site
  • Corea, república de
      • Goyang-si, Gyeonggi-Do, Corea, república de, 410-769
        • Novartis Investigative Site
      • Seoul, Corea, república de, 03080
        • Novartis Investigative Site
      • Seoul, Corea, república de, 135-710
        • Novartis Investigative Site
  • Dinamarca
      • Arhus C, Dinamarca, 8000
        • Novartis Investigative Site
      • Herlev, Dinamarca, 2730
        • Novartis Investigative Site
      • Odense, Dinamarca, 5000 C
        • Novartis Investigative Site
  • España
      • Barcelona, España, 08036
        • Novartis Investigative Site
      • Hospitalet de Llobregat, Barcelona, España, 08907
        • Novartis Investigative Site
      • Las Palmas De Gran Canaria, España, 35016
        • Novartis Investigative Site
      • Madrid, España, 28007
        • Novartis Investigative Site
      • Madrid, España, 28050
        • Novartis Investigative Site
      • Palma de Mallorca, España, 07010
        • Novartis Investigative Site
      • Pamplona, España, 31008
        • Novartis Investigative Site
      • Valencia, España, 46014
        • Novartis Investigative Site
      • Valencia, España, 46009
        • Novartis Investigative Site
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35243
        • Novartis Investigative Site
    • Arizona
      • Gilbert, Arizona, Estados Unidos, 85234
        • Novartis Investigative Site
    • California
      • Beverly Hills, California, Estados Unidos, 90211
        • Novartis Investigative Site
      • San Francisco, California, Estados Unidos, 94115
        • Novartis Investigative Site
      • Vallejo, California, Estados Unidos, 94589
        • Novartis Investigative Site
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80010
        • Novartis Investigative Site
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32204
        • Novartis Investigative Site
      • Miami Beach, Florida, Estados Unidos, 33140
        • Novartis Investigative Site
      • Orlando, Florida, Estados Unidos, 32804
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Novartis Investigative Site
      • Atlanta, Georgia, Estados Unidos, 30341
        • Novartis Investigative Site
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • Novartis Investigative Site
    • Minnesota
      • Fridley, Minnesota, Estados Unidos, 55432
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Novartis Investigative Site
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89148
        • Novartis Investigative Site
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Novartis Investigative Site
      • New Brunswick, New Jersey, Estados Unidos, 08901
        • Novartis Investigative Site
    • New York
      • New York, New York, Estados Unidos, 10029
        • Novartis Investigative Site
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599-7600
        • Novartis Investigative Site
      • Charlotte, North Carolina, Estados Unidos, 28204
        • Novartis Investigative Site
      • Durham, North Carolina, Estados Unidos, 27710
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
        • Novartis Investigative Site
      • Columbus, Ohio, Estados Unidos, 43210
        • Novartis Investigative Site
    • Oregon
      • Bend, Oregon, Estados Unidos, 97701
        • Novartis Investigative Site
      • Portland, Oregon, Estados Unidos, 97213
        • Novartis Investigative Site
      • Portland, Oregon, Estados Unidos, 97239
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Novartis Investigative Site
      • Greenville, South Carolina, Estados Unidos, 29605
        • Novartis Investigative Site
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, Estados Unidos, 75246
        • Novartis Investigative Site
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84106
        • Novartis Investigative Site
      • Salt Lake City, Utah, Estados Unidos, 84112-5550
        • Novartis Investigative Site
    • Vermont
      • Burlington, Vermont, Estados Unidos, 05403
        • Novartis Investigative Site
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • Novartis Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Novartis Investigative Site
  • Federación Rusa
      • Chelyabinsk, Federación Rusa, 454087
        • Novartis Investigative Site
      • Magnitogorsk, Federación Rusa, 455001
        • Novartis Investigative Site
      • Moscow, Federación Rusa, 115478
        • Novartis Investigative Site
      • Moscow, Federación Rusa, 143423
        • Novartis Investigative Site
      • Nizhniy Novgorod, Federación Rusa, 603081
        • Novartis Investigative Site
      • Ryazan, Federación Rusa, 390011
        • Novartis Investigative Site
      • St. Petersburg, Federación Rusa, 197758
        • Novartis Investigative Site
  • Finlandia
      • Helsinki, Finlandia, 00029
        • Novartis Investigative Site
      • Jyvaskyla, Finlandia, 40620
        • Novartis Investigative Site
      • Tampere, Finlandia, 33520
        • Novartis Investigative Site
      • Turku, Finlandia, 20520
        • Novartis Investigative Site
  • Francia
      • Bordeaux, Francia, 33075
        • Novartis Investigative Site
      • Grenoble, Francia, 38043
        • Novartis Investigative Site
      • Lille, Francia, 59037
        • Novartis Investigative Site
      • Marseille cedex 5, Francia, 13385
        • Novartis Investigative Site
      • Montpellier cedex 5, Francia, 34295
        • Novartis Investigative Site
      • Nantes, Francia, 44093
        • Novartis Investigative Site
      • Nice, Francia, 06202
        • Novartis Investigative Site
      • Paris Cedex 10, Francia, 75475
        • Novartis Investigative Site
      • Reims Cedex, Francia, 51092
        • Novartis Investigative Site
      • Rennes Cedex, Francia, 35042
        • Novartis Investigative Site
      • Villejuif cedex, Francia, 94805
        • Novartis Investigative Site
  • Hungría
      • Budapest, Hungría, H-1122
        • Novartis Investigative Site
      • Budapest, Hungría, 1062
        • Novartis Investigative Site
      • Debrecen, Hungría, 4032
        • Novartis Investigative Site
      • Gyor, Hungría, H-9024
        • Novartis Investigative Site
      • Kaposvar, Hungría, 7400
        • Novartis Investigative Site
      • Miskolc, Hungría, 3526
        • Novartis Investigative Site
      • Szeged, Hungría, 6720
        • Novartis Investigative Site
  • Irlanda
      • Co.Cork, Irlanda
        • Novartis Investigative Site
      • Dublin, Irlanda, 7
        • Novartis Investigative Site
      • Dublin, Irlanda, 9
        • Novartis Investigative Site
      • Dublin, Irlanda, 4
        • Novartis Investigative Site
      • Galway, Irlanda
        • 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
  • Noruega
      • Kristiansand, Noruega, 4604
        • Novartis Investigative Site
      • Lorenskog, Noruega, 1478
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      • Oslo, Noruega, 0310
        • Novartis Investigative Site
  • Nueva Zelanda
      • Christchurch, Nueva Zelanda, 8011
        • Novartis Investigative Site
      • Newtown, Wellington, Nueva Zelanda, 6002
        • Novartis Investigative Site
  • Países Bajos
      • Amsterdam, Países Bajos, 1066 CX
        • Novartis Investigative Site
      • Amsterdam, Países Bajos, 1081 HV
        • Novartis Investigative Site
      • Groningen, Países Bajos, 9713 GZ
        • Novartis Investigative Site
      • Leeuwarden, Países Bajos, 8934 AD
        • Novartis Investigative Site
      • Leiden, Países Bajos, 2333 ZA
        • Novartis Investigative Site
      • Rotterdam, Países Bajos, 3015 GD
        • Novartis Investigative Site
  • Polonia
      • Gdansk, Polonia, 80-215
        • Novartis Investigative Site
      • Konin, Polonia, 62-500
        • Novartis Investigative Site
      • Poznan, Polonia, 60-693
        • Novartis Investigative Site
      • Warszawa, Polonia, 02-781
        • Novartis Investigative Site
  • Reino Unido
      • Cambridge, Reino Unido, CB2 0QQ
        • Novartis Investigative Site
      • Glasgow, Reino Unido, G12 0YN
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      • London, Reino Unido, NW3 2QG
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      • London, Reino Unido, SE1 7EH
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      • Manchester, Reino Unido, M20 4BX
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      • Southampton, Reino Unido, SO16 6YD
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      • Swansea, Reino Unido, SA2 8QA
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  • Suecia
      • Linkoping, Suecia, SE-581 85
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      • Umea, Suecia, SE-901 85
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  • Suiza
      • Basel, Suiza, 4031
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      • Lausanne, Suiza, 1011
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      • Zurich, Suiza, 8091
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  • Taiwán
      • Tainan, Taiwán, 704
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      • Taipei, Taiwán, 100
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      • Taoyuan, Taiwán, 333
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  • Ucrania
      • Dnipropetrovsk, Ucrania, 49102
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      • Donetsk, Ucrania, 83092
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      • Kharkiv, Ucrania, 61070
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      • Kyiv, Ucrania, 03022
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      • Lviv, Ucrania, 79031
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      • Sumy, Ucrania, 40005
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      • Uzhgorod, Ucrania, 88017
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Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Dabrafenib plus Trametinib
BRAF inhibitor plus MEK inhibitor
Droga: Dabrafenib
Dabrafenib 150 mg twice daily orally
Otros nombres:
  • GSK2118436
Droga: Trametinib
Trametinib 2 mg once daily orally
Otros nombres:
  • GSK1120212
Comparador activo: Vemurafenib
BRAF inhibitor
Droga: Vemurafenib
Vemurafenib 960 mg twice daily orally
Otros nombres:
  • Monoterapia

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-Free Survival (PFS), as Assessed by the Investigator
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

4 de junio de 2012

Finalización primaria (Actual)

17 de abril de 2014

Finalización del estudio (Actual)

25 de abril de 2019

Fechas de registro del estudio

Enviado por primera vez

10 de mayo de 2012

Primero enviado que cumplió con los criterios de control de calidad

10 de mayo de 2012

Publicado por primera vez (Estimar)

14 de mayo de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de febrero de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

8 de febrero de 2021

Última verificación

1 de febrero de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 116513
  • CDRB436B2302 (Otro identificador: Novartis)
  • 2011-006088-23 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Sí

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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