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

29. oktober 2020 opdateret af: 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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

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.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
1538

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: 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.
Medicin: 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.
Andre navne:
  • PZP034
Medicin: pazopanib
Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
Andre navne:
  • Votrient
Placebo komparator: 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.
Medicin: 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.
Medicin: placebo
placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Tidsramme: 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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Tidsramme: 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
Tidsramme: yearly for 4 years
yearly for 4 years
DFS With Pazopanib vs. Placebo
Tidsramme: 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
Tidsramme: 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
Tidsramme: yearly for 4 years
yearly for 4 years
DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
30. november 2010

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
15. oktober 2015

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
15. april 2019

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
14. oktober 2010

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
4. november 2010

Først opslået (Skøn)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
7. november 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
23. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
29. oktober 2020

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 113387
  • 2010-020965-26 (EudraCT nummer)
  • CPZP034D2301 (Anden identifikator: Novartis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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