Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

29. října 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

1538

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: 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.
Ostatní jména:
  • PZP034
Lék: pazopanib
Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
Ostatní jména:
  • Votrient
Komparátor placeba: 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.
Lék: 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.
Lék: placebo
placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Časové okno: 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
Časové okno: yearly for 4 years
yearly for 4 years
DFS With Pazopanib vs. Placebo
Časové okno: 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
Časové okno: 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
Časové okno: yearly for 4 years
yearly for 4 years
DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novartis Pharmaceuticals

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

30. listopadu 2010

Primární dokončení (Aktuální)

15. října 2015

Dokončení studie (Aktuální)

15. dubna 2019

Termíny zápisu do studia

První předloženo

14. října 2010

První předloženo, které splnilo kritéria kontroly kvality

4. listopadu 2010

První zveřejněno (Odhad)

7. listopadu 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. listopadu 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. října 2020

Naposledy ověřeno

1. října 2020

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 113387
  • 2010-020965-26 (Číslo EudraCT)
  • CPZP034D2301 (Jiný identifikátor: Novartis)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na pazopanib

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Georgia

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit