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A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC) (PROTECT)

29 października 2020 zaktualizowane przez: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

The primary objective of this ongoing study was to evaluate DFS with pazopanib 600 mg daily initial dose as compared with placebo as adjuvant therapy for subjects with localized/locally advanced RCC following nephrectomy.

Subjects with locally recurrent renal cell carcinoma (RCC), bilateral RCC, or history of another malignancy were excluded from enrolling in the study.

The study was comprised of three successive study periods: 1) the Screening/Baseline period, 2) the study treatment period, and 3) the DFS /OS follow-up period. The Screening/Baseline period had a maximum duration of 12 weeks from the date of nephrectomy to the date of randomization.

After a subject met all the eligibility criteria and completed all the required baseline assessments, the subject was randomized in a 1:1 ratio to receive once daily blinded treatment with either pazopanib 600 mg as initial dose or matching placebo based on pre-defined stratification factors.

Subjects received continuous daily treatment until completion of the 12-month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed. During the study treatment and DFS follow-up periods, subjects received routine safety and efficacy assessments.

The study treatment period was 12 months. Subjects received continuous daily treatment until completion of the 12 month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed.

All subjects, regardless of study treatment status (i.e. premature discontinuation or completion of the 12-month treatment), were to be followed with routine imaging assessments and remain blinded until objective evidence of disease recurrence was obtained or until the study achieved the required number of events for the primary endpoint of DFS (319 events). After objective evidence of disease recurrence was obtained, subjects could be unblinded and received the first-line treatment for metastatic RCC per local standard of care.

All subjects were off treatment for at least 4 years at the end of study.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

1538

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
      • San Miguel de Tucuman, Argentyna, T4000IAK
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      • Santa Fe, Argentyna, 3000
        • Novartis Investigative Site
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentyna, B1880BBF
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      • Capital Federal, Buenos Aires, Argentyna, C1426ANZ
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      • Ciudad Aut6noma de Buenos Aires, Buenos Aires, Argentyna, C1050AAK
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      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentyna, C1280AEB
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      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentyna, C1405BCH
        • Novartis Investigative Site
      • Quilmes, Buenos Aires, Argentyna, 1878
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    • Córdova
      • Cordoba, Córdova, Argentyna, X5006HBF
        • Novartis Investigative Site
      • Cordoba, Córdova, Argentyna, X5003DCE
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    • Río Negro
      • Cipolletti, Río Negro, Argentyna, R8324EMB
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    • Santa Fe
      • Rosario, Santa Fe, Argentyna, S2000KZE
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  • Austria
      • Graz, Austria, 8036
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      • Innsbruck, Austria, 6020
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      • Salzburg, Austria, 5020
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      • Salzburg, Austria, A-5020
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      • Vienna, Austria, A-1090
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      • Vienna, Austria, 1130
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  • Belgia
      • Hasselt, Belgia, 3500
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      • Jette, Belgia, 1090
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      • Liege, Belgia, 4000
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      • Namur, Belgia, 5000
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      • Roeselare, Belgia, 8800
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      • Wilrijk, Belgia, 2610
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  • Brazylia
      • Rio de Janeiro, Brazylia, 20 551-030
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      • Rio de Janeiro, Brazylia, 20231-050
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    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazylia, 30130-100
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    • Paraná
      • Curitiba, Paraná, Brazylia, 81520-060
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    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazylia, 98700-000
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      • Porto Alegre, Rio Grande Do Sul, Brazylia, 90610000
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    • São Paulo
      • Barretos, São Paulo, Brazylia, 14784-400
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      • Campinas, São Paulo, Brazylia, 13083-970
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      • Sao Paulo, São Paulo, Brazylia, 01246-000
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      • Sao Paulo, São Paulo, Brazylia, 05651-901
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      • Sao Paulo, São Paulo, Brazylia, 01308-050
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      • Sao Paulo, São Paulo, Brazylia, 08270-070
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  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7500921
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    • Valparaíso
      • Vina del Mar, Valparaíso, Chile, 254-0364
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  • Chiny
      • Beijing, Chiny, 100021
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      • Beijing, Chiny, 100034
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      • Beijing, Chiny, 100191
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      • Beijing, Chiny, 100853
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      • Shanghai, Chiny, 200032
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      • Shanghai, Chiny, 200127
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      • Shanghai, Chiny, 200025
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      • Shanghai, Chiny, 200040
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      • Tianjin, Chiny, 300060
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    • Hubei
      • Wuhan, Hubei, Chiny, 430030
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    • Zhejiang
      • Hangzhou, Zhejiang, Chiny, 310009
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      • Hangzhou, Zhejiang, Chiny, 310003
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  • Czechy
      • Brno, Czechy, 656 53
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      • Brno, Czechy, 656 91
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      • Hradec Kralove, Czechy, 500 05
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      • Novy Jicin, Czechy, 741 01
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      • Olomouc, Czechy, 775 20
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      • Ostrava - Poruba, Czechy, 708 52
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      • Plzen, Czechy, 304 60
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      • Praha 2, Czechy, 12808
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      • Praha 8, Czechy, 180 00
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      • Usti nad Labem, Czechy, 40113
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  • Dania
      • Aarhus, Dania, 8000 Aarhus C
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      • Dk-2730 Herlev, Dania, 2730
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      • Odense C, Dania, 5000
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  • Federacja Rosyjska
      • Arkhangelsk, Federacja Rosyjska, 163045
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      • Barnaul, Federacja Rosyjska, 656049
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      • Chelyabinsk, Federacja Rosyjska, 454087
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      • Ekaterinburg, Federacja Rosyjska, 620102
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      • Kazan, Federacja Rosyjska, 420029
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      • Moscow, Federacja Rosyjska, 115478
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      • Moscow, Federacja Rosyjska, 117997
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      • Obninsk, Federacja Rosyjska, 249036
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      • Omsk, Federacja Rosyjska, 644013
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      • Rostov-na-Donu, Federacja Rosyjska
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      • Ryazan, Federacja Rosyjska, 390011
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      • Saint Petersburg, Federacja Rosyjska
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      • St. Petersburg, Federacja Rosyjska, 197758
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      • Stavropol, Federacja Rosyjska, 355047
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      • Ufa,, Federacja Rosyjska, 450054
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  • Francja
      • ANGERS Cedex 2, Francja, 49055
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      • Besancon cedex, Francja, 25030
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      • Bordeaux, Francja, 33075
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      • Caen Cedex, Francja, 14076
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      • Hyeres, Francja, 83400
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      • Le Mans, Francja, 72000
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      • Marseille cedex 5, Francja, 13385
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      • Montpellier Cedex 5, Francja, 34295
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      • Paris, Francja, 75014
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      • Paris Cedex 15, Francja, 75908
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      • Poitiers Cedex, Francja, 86021
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      • Reims, Francja, 51100
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      • Rennes, Francja, 35042
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      • Saint Herblain, Francja, 44805
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      • Strasbourg Cedex, Francja, 67091
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      • Strasbourg cedex, Francja, 67085
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      • Toulouse, Francja, 31076
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      • Tours Cedex 9, Francja, 37044
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  • Grecja
      • Athens, Grecja, 115 22
        • Novartis Investigative Site
      • Heraklion, Crete, Grecja, 71100
        • Novartis Investigative Site
      • Patra, Grecja, 26504
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      • Thessaloniki, Grecja
        • Novartis Investigative Site
  • Hiszpania
      • Badalona, Hiszpania, 08916
        • Novartis Investigative Site
      • Barcelona, Hiszpania, 08035
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      • Cordoba, Hiszpania, 14004
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      • Dos Hermanas (Sevilla), Hiszpania, 41700
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      • Madrid, Hiszpania, 28041
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      • Madrid, Hiszpania, 28007
        • Novartis Investigative Site
      • Madrid, Hiszpania, 28033
        • Novartis Investigative Site
      • Madrid, Hiszpania, 28050
        • Novartis Investigative Site
      • Malaga, Hiszpania, 29010
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      • Oviedo, Hiszpania, 33006
        • Novartis Investigative Site
      • Sevilla, Hiszpania, 41013
        • Novartis Investigative Site
      • Valencia, Hiszpania, 46009
        • Novartis Investigative Site
  • Indyk
      • Ankara, Indyk, 06100
        • Novartis Investigative Site
      • Ankara, Indyk, 06590
        • Novartis Investigative Site
      • Istanbul, Indyk, 34390
        • Novartis Investigative Site
      • Izmir, Indyk, 35100
        • Novartis Investigative Site
  • Irlandia
      • Cork, Irlandia
        • Novartis Investigative Site
      • Dublin, Irlandia, 7
        • Novartis Investigative Site
      • Dublin, Irlandia, 9
        • Novartis Investigative Site
      • Galway, Irlandia
        • Novartis Investigative Site
      • Tallaght, Dublin, Irlandia, 24
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  • Izrael
      • Haifa, Izrael, 31096
        • Novartis Investigative Site
      • Jerusalem, Izrael, 91120
        • Novartis Investigative Site
      • Petach-Tikva, Izrael, 49100
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      • Rehovot, Izrael, 76100
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      • Tel Aviv, Izrael, 64239
        • Novartis Investigative Site
      • Zrifin, Izrael, 70300
        • Novartis Investigative Site
  • Japonia
      • Fukuoka, Japonia, 812-8582
        • Novartis Investigative Site
      • Hokkaido, Japonia, 060-8543
        • Novartis Investigative Site
      • Hokkaido, Japonia, 060-8648
        • Novartis Investigative Site
      • Kanagawa, Japonia, 236-0004
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      • Okayama, Japonia, 700-8558
        • Novartis Investigative Site
      • Osaka, Japonia, 589-8511
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      • Shizuoka, Japonia, 431-3192
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      • Tokyo, Japonia, 162-8666
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      • Tokyo, Japonia, 113-8603
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      • Tokyo, Japonia, 160-8582
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      • Yamagata, Japonia, 990-9585
        • Novartis Investigative Site
  • Kanada
      • Quebec, Kanada, G1R 2J6
        • Novartis Investigative Site
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4N2
        • Novartis Investigative Site
      • Edmonton, Alberta, Kanada, T6G 1Z2
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z 1M9
        • Novartis Investigative Site
    • New Brunswick
      • Moncton, New Brunswick, Kanada, E1C 6Z8
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3H 1V7
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Kanada, L8V 5C2
        • Novartis Investigative Site
      • London, Ontario, Kanada, N6A 4L6
        • Novartis Investigative Site
      • Oshawa, Ontario, Kanada, L1G 2B9
        • Novartis Investigative Site
      • Ottawa, Ontario, Kanada, K1H 8L6
        • Novartis Investigative Site
      • Toronto, Ontario, Kanada, M5G 2M9
        • Novartis Investigative Site
      • Toronto, Ontario, Kanada, M4N 3M5
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Kanada, H2L 4M1
        • Novartis Investigative Site
  • Luksemburg
      • Luxembourg, Luksemburg, 1210
        • Novartis Investigative Site
  • Niemcy
      • Berlin, Niemcy, 10967
        • Novartis Investigative Site
      • Berlin, Niemcy, 12200
        • Novartis Investigative Site
      • Berlin, Niemcy, 10719
        • Novartis Investigative Site
      • Bremen, Niemcy, 28177
        • Novartis Investigative Site
      • Hamburg, Niemcy, 20246
        • Novartis Investigative Site
    • Baden-Wuerttemberg
      • Kirchheim, Baden-Wuerttemberg, Niemcy, 73230
        • Novartis Investigative Site
      • Ravensburg, Baden-Wuerttemberg, Niemcy, 88212
        • Novartis Investigative Site
      • Sigmaringen, Baden-Wuerttemberg, Niemcy, 72488
        • Novartis Investigative Site
      • Stuttgart, Baden-Wuerttemberg, Niemcy, 70174
        • Novartis Investigative Site
      • Tuebingen, Baden-Wuerttemberg, Niemcy, 72076
        • Novartis Investigative Site
      • Ulm, Baden-Wuerttemberg, Niemcy, 89075
        • Novartis Investigative Site
    • Bayern
      • Erlangen, Bayern, Niemcy, 91054
        • Novartis Investigative Site
      • Fuerth, Bayern, Niemcy, 90766
        • Novartis Investigative Site
      • Muenchen, Bayern, Niemcy, 81675
        • Novartis Investigative Site
      • Regensburg, Bayern, Niemcy, 93053
        • Novartis Investigative Site
      • Weiden, Bayern, Niemcy, 92637
        • Novartis Investigative Site
    • Hessen
      • Frankfurt, Hessen, Niemcy, 60590
        • Novartis Investigative Site
      • Marburg, Hessen, Niemcy, 35043
        • Novartis Investigative Site
      • Offenbach, Hessen, Niemcy, 63069
        • Novartis Investigative Site
    • Niedersachsen
      • Braunschweig, Niedersachsen, Niemcy, 38126
        • Novartis Investigative Site
      • Goslar, Niedersachsen, Niemcy, 38642
        • Novartis Investigative Site
      • Hannover, Niedersachsen, Niemcy, 30625
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Niemcy, 52074
        • Novartis Investigative Site
      • Bergisch Gladbach, Nordrhein-Westfalen, Niemcy, 51465
        • Novartis Investigative Site
      • Bonn, Nordrhein-Westfalen, Niemcy, 53127
        • Novartis Investigative Site
      • Duisburg, Nordrhein-Westfalen, Niemcy, 47179
        • Novartis Investigative Site
      • Essen, Nordrhein-Westfalen, Niemcy, 45122
        • Novartis Investigative Site
      • Moenchengladbach, Nordrhein-Westfalen, Niemcy, 41063
        • Novartis Investigative Site
      • Muenster, Nordrhein-Westfalen, Niemcy, 48149
        • Novartis Investigative Site
      • Neuss, Nordrhein-Westfalen, Niemcy, 41464
        • Novartis Investigative Site
      • Velbert, Nordrhein-Westfalen, Niemcy, 42551
        • Novartis Investigative Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Niemcy, 55131
        • Novartis Investigative Site
    • Saarland
      • Homburg, Saarland, Niemcy, 66421
        • Novartis Investigative Site
    • Sachsen
      • Chemnitz, Sachsen, Niemcy, 09130
        • Novartis Investigative Site
      • Leipzig, Sachsen, Niemcy, 04277
        • Novartis Investigative Site
      • Plauen, Sachsen, Niemcy, 08523
        • Novartis Investigative Site
    • Sachsen-Anhalt
      • Dessau, Sachsen-Anhalt, Niemcy, 06846
        • Novartis Investigative Site
      • Eisleben, Sachsen-Anhalt, Niemcy, 06295
        • Novartis Investigative Site
      • Halle, Sachsen-Anhalt, Niemcy, 06120
        • Novartis Investigative Site
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Niemcy, 23566
        • Novartis Investigative Site
    • Thueringen
      • Jena, Thueringen, Niemcy, 07768
        • Novartis Investigative Site
  • Polska
      • Gdansk, Polska, 80-219
        • Novartis Investigative Site
      • Konin, Polska, 62-500
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      • Krakow, Polska, 31-108
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      • Krakow, Polska, 31-115
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      • Lublin, Polska, 20-090
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      • Warszawa, Polska, 02-781
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      • Warszawa, Polska, 04-125
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      • Warszawa, Polska, 02-776
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      • Wroclaw, Polska, 50-556
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  • Republika Korei
      • Daejeon, Republika Korei, 35015
        • Novartis Investigative Site
      • Goyang-si, Gyeonggi-do, Republika Korei, 410-769
        • Novartis Investigative Site
      • Jeonju-si, Republika Korei, 54907
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      • Seongnam-si Gyeonggi-do, Republika Korei, 13620
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      • Seoul, Republika Korei, 03080
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      • Seoul, Republika Korei, 06351
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      • Seoul, Republika Korei, 120-752
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      • Seoul, Republika Korei, 136-705
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      • Songpa-gu, Seoul, Republika Korei, 138-736
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  • Stany Zjednoczone
    • Arkansas
      • Jonesboro, Arkansas, Stany Zjednoczone, 72401
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    • California
      • Antioch, California, Stany Zjednoczone, 94531
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      • Beverly Hills, California, Stany Zjednoczone, 90211
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      • Fresno, California, Stany Zjednoczone, 93720
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      • La Jolla, California, Stany Zjednoczone, 92093
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      • Los Angeles, California, Stany Zjednoczone, 90033
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      • Los Angeles, California, Stany Zjednoczone, 90095
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      • Los Angeles, California, Stany Zjednoczone, 90048-0750
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      • Oakland, California, Stany Zjednoczone, 94611
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      • Sacramento, California, Stany Zjednoczone, 95825
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      • San Francisco, California, Stany Zjednoczone, 94115
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      • South San Francisco, California, Stany Zjednoczone, 94080
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      • Stanford, California, Stany Zjednoczone, 94305
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      • Vallejo, California, Stany Zjednoczone, 94589
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    • Colorado
      • Fort Collins, Colorado, Stany Zjednoczone, 80528
        • Novartis Investigative Site
    • District of Columbia
      • Washington, District of Columbia, Stany Zjednoczone, 20007
        • Novartis Investigative Site
    • Florida
      • Fort Myers, Florida, Stany Zjednoczone, 33916
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      • Tampa, Florida, Stany Zjednoczone, 33612
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    • Georgia
      • Athens, Georgia, Stany Zjednoczone, 30607
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      • Macon, Georgia, Stany Zjednoczone, 31201
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    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60637
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46202
        • Novartis Investigative Site
    • Iowa
      • Iowa City, Iowa, Stany Zjednoczone, 52242
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21231
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Novartis Investigative Site
      • Boston, Massachusetts, Stany Zjednoczone, 02115
        • Novartis Investigative Site
      • Boston, Massachusetts, Stany Zjednoczone, 02215
        • Novartis Investigative Site
      • Burlington, Massachusetts, Stany Zjednoczone, 01805
        • Novartis Investigative Site
    • Michigan
      • Detroit, Michigan, Stany Zjednoczone, 48201
        • Novartis Investigative Site
    • Minnesota
      • Rochester, Minnesota, Stany Zjednoczone, 55905
        • Novartis Investigative Site
      • Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, Stany Zjednoczone, 63110
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, Stany Zjednoczone, 68510
        • Novartis Investigative Site
      • Omaha, Nebraska, Stany Zjednoczone, 68114
        • Novartis Investigative Site
      • Omaha, Nebraska, Stany Zjednoczone, 68118
        • Novartis Investigative Site
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89169
        • Novartis Investigative Site
    • New Jersey
      • Hackensack, New Jersey, Stany Zjednoczone, 07601
        • Novartis Investigative Site
    • New York
      • Albany, New York, Stany Zjednoczone, 12206
        • Novartis Investigative Site
      • Buffalo, New York, Stany Zjednoczone, 14263
        • Novartis Investigative Site
      • New York, New York, Stany Zjednoczone, 10003
        • Novartis Investigative Site
      • New York, New York, Stany Zjednoczone, 10021
        • Novartis Investigative Site
      • New York, New York, Stany Zjednoczone, 10065
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, Stany Zjednoczone, 27710
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone, 45242
        • Novartis Investigative Site
      • Cleveland, Ohio, Stany Zjednoczone, 44195
        • Novartis Investigative Site
      • Columbus, Ohio, Stany Zjednoczone, 43210
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97213
        • Novartis Investigative Site
      • Springfield, Oregon, Stany Zjednoczone, 97477
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19107
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19111
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19106
        • Novartis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, Stany Zjednoczone, 02903
        • Novartis Investigative Site
      • Providence, Rhode Island, Stany Zjednoczone, 02906
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29425
        • Novartis Investigative Site
    • Tennessee
      • Chattanooga, Tennessee, Stany Zjednoczone, 37404
        • Novartis Investigative Site
      • Memphis, Tennessee, Stany Zjednoczone, 38120
        • Novartis Investigative Site
      • Nashville, Tennessee, Stany Zjednoczone, 37203
        • Novartis Investigative Site
      • Nashville, Tennessee, Stany Zjednoczone, 37232
        • Novartis Investigative Site
    • Texas
      • Bedford, Texas, Stany Zjednoczone, 76022
        • Novartis Investigative Site
      • Dallas, Texas, Stany Zjednoczone, 75246
        • Novartis Investigative Site
      • Houston, Texas, Stany Zjednoczone, 77030
        • Novartis Investigative Site
      • Houston, Texas, Stany Zjednoczone, 77024
        • Novartis Investigative Site
      • San Antonio, Texas, Stany Zjednoczone, 78217
        • Novartis Investigative Site
      • Tyler, Texas, Stany Zjednoczone, 75702
        • Novartis Investigative Site
    • Virginia
      • Hampton, Virginia, Stany Zjednoczone, 23666
        • Novartis Investigative Site
      • Richmond, Virginia, Stany Zjednoczone, 23230
        • Novartis Investigative Site
      • Virginia Beach, Virginia, Stany Zjednoczone, 23462
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98109
        • Novartis Investigative Site
  • Słowacja
      • Banska Bystrica, Słowacja, 975 17
        • Novartis Investigative Site
      • Bratislava, Słowacja, 833 05
        • Novartis Investigative Site
      • Kosice, Słowacja, 041 66
        • Novartis Investigative Site
      • Martin, Słowacja, 036 59
        • Novartis Investigative Site
      • Zilina, Słowacja, 012 07
        • Novartis Investigative Site
  • Węgry
      • Budapest, Węgry, 1082
        • Novartis Investigative Site
      • Budapest, Węgry, 1097
        • Novartis Investigative Site
      • Budapest, Węgry, 1122
        • Novartis Investigative Site
      • Miskolc, Węgry, 3526
        • Novartis Investigative Site
      • Nyiregyhaza, Węgry, 4400
        • Novartis Investigative Site
      • Szombathely, Węgry, 9700
        • Novartis Investigative Site
  • Włochy
    • Campania
      • Napoli, Campania, Włochy, 80131
        • Novartis Investigative Site
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Włochy, 40138
        • Novartis Investigative Site
      • Meldola (FC), Emilia-Romagna, Włochy, 47014
        • Novartis Investigative Site
      • Modena, Emilia-Romagna, Włochy, 41100
        • Novartis Investigative Site
    • Lazio
      • Roma, Lazio, Włochy, 00144
        • Novartis Investigative Site
      • Roma, Lazio, Włochy, 00152
        • Novartis Investigative Site
    • Lombardia
      • Milano, Lombardia, Włochy, 20133
        • Novartis Investigative Site
      • Rozzano (MI), Lombardia, Włochy, 20089
        • Novartis Investigative Site
    • Piemonte
      • Candiolo (TO), Piemonte, Włochy, 10060
        • Novartis Investigative Site
    • Toscana
      • Arezzo, Toscana, Włochy, 52100
        • Novartis Investigative Site
    • Umbria
      • Terni, Umbria, Włochy, 05100
        • Novartis Investigative Site
    • Veneto
      • Negrar, Veneto, Włochy, 37024
        • Novartis Investigative Site
  • Zjednoczone Królestwo
      • Brighton, Zjednoczone Królestwo, BN2 5BE
        • Novartis Investigative Site
      • Cornwall, Zjednoczone Królestwo, TR1 3LJ
        • Novartis Investigative Site
      • Guildford, Zjednoczone Królestwo, GU2 7XX
        • Novartis Investigative Site
      • London, Zjednoczone Królestwo, SE1 9RT
        • Novartis Investigative Site
      • London, Zjednoczone Królestwo, NW3 2QG
        • Novartis Investigative Site
      • Manchester, Zjednoczone Królestwo, M20 4BX
        • Novartis Investigative Site
      • Preston, Zjednoczone Królestwo, PR2 9HT
        • Novartis Investigative Site
      • Swansea, Zjednoczone Królestwo, SA2 8QA
        • Novartis Investigative Site
      • Wolverhampton, Zjednoczone Królestwo, WV10 0QP
        • Novartis Investigative Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Signed written informed consent
  • Diagnosis of RCC with clear-cell or predominant clear-cell histology

  • Subjects with non-metastatic disease (M0) fulfilling any of the following combinations of pathologic staging based on American Joint Committee on Cancer (AJCC) TNM staging version 2010 and Fuhrman nuclear grading.

    • pT2, G3 or G4, N0; or,
    • pT3, G any, N0; or,
    • pT4, G any, N0; or,
    • pT any, G any, N1

  • Fulfill all of the following criteria of disease-free status at baseline:

    • Had complete gross surgical resection of all RCC via radical or partial nephrectomy using either open or laparoscopic technique.
    • Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual tumor lesions as confirmed centrally by an independent radiologist.
  • Received no prior adjuvant or neo-adjuvant treatment for RCC
  • Recovered from nephrectomy: any surgery related toxicities should be reduced to ≤ grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE) (Version 4)
  • Karnofsky performance scale (KPS) of ≥ 80
  • Adequate organ system function

Exclusion Criteria:

  • History of another malignancy. Exception: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible

  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:

    • Active peptic ulcer disease
    • Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
    • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
  • Active diarrhea of any grade

  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:

    • Malabsorption syndrome
    • Major resection of the stomach or small bowel
  • History of human immunodeficiency virus (HIV) infection
  • History of active hepatitis
  • Presence of uncontrolled infection.

  • History of any one or more of the following cardiovascular conditions within the past 6 months:

    • Cardiac angioplasty or stenting
    • Myocardial infarction
    • Unstable angina
    • Coronary artery bypass graft surgery
    • Symptomatic peripheral vascular disease
  • History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure
  • History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Corrected QT interval (QTc) > 480 milliseconds (msec)
  • Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg.

Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study (see Section 7.6.2 for instruction on blood pressure measurement and obtaining mean blood pressure values).

  • Evidence of active bleeding or bleeding diathesis
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
  • Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study treatment and for the duration of the study.
  • Concurrent therapy given to treat cancer including treatment with an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug.
  • Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
  • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or excipients that in the opinion of the investigator contraindicates their participation.
  • Prior or current use of systemic anti-VEGF inhibitors, cytokines (e.g. interferon, interleukin 2).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: pazopanib
Pazopanib oral agent, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.
Lek: pazopanib
Pazopanib monohydrochloride salt was supplied as aqueous, film-coated tablets containing 200 mg of the free base. The 200 mg tablets were oval-shaped and white in color.
Inne nazwy:
  • PZP034
Lek: pazopanib
Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
Inne nazwy:
  • Votrient
Komparator placebo: placebo
placebo matching pazopanib 200 mg tablets, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.
Lek: placebo
Placebo matching pazopanib was supplied as aqueous, film-coated tablets containing 200 mg of the free base. The 200 mg tablets were oval-shaped and white in color.
Lek: placebo
placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Ramy czasowe: approximately 5 years
DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.
approximately 5 years

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Ramy czasowe: approximately 8.5 years

Overall survival is defined as the time from randomization until death due to any cause.

For subjects who did not die, time to death was censored at the last date of known contact.
approximately 8.5 years
DFS Rates at Yearly Time Points With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Ramy czasowe: yearly for 4 years
yearly for 4 years
DFS With Pazopanib vs. Placebo
Ramy czasowe: approximately 5 years
DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.
approximately 5 years
OS With Pazopanib vs. Placebo
Ramy czasowe: approximately 8.5 years

Overall survival is defined as the time from randomization until death due to any cause.

For subjects who do not die, time to death will be censored at the last date of known contact.
approximately 8.5 years
DFS Rates at Yearly Time Points With Pazopanib vs. Placebo
Ramy czasowe: yearly for 4 years
yearly for 4 years
DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo
Ramy czasowe: approximately 5 years
DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.
approximately 5 years
OS With Pazopanib 800 mg Daily Initial Dose vs. Placebo
Ramy czasowe: approximately 8.5 years

Overall survival is defined as the time from randomization until death due to any cause.

For subjects who did not die, time to death was censored at the last date of known contact.
approximately 8.5 years
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index -19 (FACT FKSI-19) Total Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (FKSI-DRS-P, FKSI-DRS-E, FKSI-TSE, FKSI-FWB) experienced in the past 7 days. Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). A negative mean indicates a worsening of condition. DFS: disease-free survival; FU: follow up
Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). A negative mean indicates a worsening of condition.
Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative mean indicates a worsening of condition.
Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.
Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.
Week 52, 24M DFS FU, 36M DFS FU,48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health outcome and quality of life measured by EQ-5D thermometer (thermo) score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (FKSI-DRS-P, FKSI-DRS-E, FKSI-TSE, FKSI-FWB) experienced in the past 7 days. Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). A negative mean indicates a worsening of condition. DFS: disease-free survival; FU: follow up
Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). A negative mean indicates a worsening of condition.
Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-emotional (DRS-E) Domain Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4).A negative mean indicates a worsening of condition.
Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.
Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). A negative mean indicates a worsening of condition.
Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score
Ramy czasowe: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health outcome and quality of life measured by using EQ-5D thermometer score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Pharmaceuticals

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 listopada 2010

Zakończenie podstawowe (Rzeczywisty)

15 października 2015

Ukończenie studiów (Rzeczywisty)

15 kwietnia 2019

Daty rejestracji na studia

Pierwszy przesłany

14 października 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 listopada 2010

Pierwszy wysłany (Oszacować)

7 listopada 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 listopada 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 października 2020

Ostatnia weryfikacja

1 października 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 113387
  • 2010-020965-26 (Numer EudraCT)
  • CPZP034D2301 (Inny identyfikator: Novartis)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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