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

29 de octubre de 2020 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

1538

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

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

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 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: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: 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.
Otros nombres:
  • PZP034
Droga: pazopanib
Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
Otros nombres:
  • Votriente
Comparador de placebos: 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.
Droga: 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.
Droga: placebo
placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Periodo de tiempo: 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
Periodo de tiempo: yearly for 4 years
yearly for 4 years
DFS With Pazopanib vs. Placebo
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: yearly for 4 years
yearly for 4 years
DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

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)

30 de noviembre de 2010

Finalización primaria (Actual)

15 de octubre de 2015

Finalización del estudio (Actual)

15 de abril de 2019

Fechas de registro del estudio

Enviado por primera vez

14 de octubre de 2010

Primero enviado que cumplió con los criterios de control de calidad

4 de noviembre de 2010

Publicado por primera vez (Estimar)

7 de noviembre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de noviembre de 2020

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

29 de octubre de 2020

Última verificación

1 de octubre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 113387
  • 2010-020965-26 (Número EudraCT)
  • CPZP034D2301 (Otro identificador: Novartis)

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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