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

29 октября 2020 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

1538

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австрия
      • Graz, Австрия, 8036
        • Novartis Investigative Site
      • Innsbruck, Австрия, 6020
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      • Salzburg, Австрия, 5020
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      • Salzburg, Австрия, A-5020
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      • Vienna, Австрия, A-1090
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      • Vienna, Австрия, 1130
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  • Аргентина
      • San Miguel de Tucuman, Аргентина, T4000IAK
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      • Santa Fe, Аргентина, 3000
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    • Buenos Aires
      • Berazategui, Buenos Aires, Аргентина, B1880BBF
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      • Capital Federal, Buenos Aires, Аргентина, C1426ANZ
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      • Ciudad Aut6noma de Buenos Aires, Buenos Aires, Аргентина, C1050AAK
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      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Аргентина, C1280AEB
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      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Аргентина, C1405BCH
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      • Quilmes, Buenos Aires, Аргентина, 1878
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      • Cordoba, Córdova, Аргентина, X5006HBF
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      • Cordoba, Córdova, Аргентина, X5003DCE
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      • Rosario, Santa Fe, Аргентина, S2000KZE
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      • Hasselt, Бельгия, 3500
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      • Liege, Бельгия, 4000
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      • Namur, Бельгия, 5000
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      • Rio de Janeiro, Бразилия, 20231-050
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  • Греция
      • Athens, Греция, 115 22
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      • Heraklion, Crete, Греция, 71100
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      • Patra, Греция, 26504
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      • Thessaloniki, Греция
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  • Дания
      • Aarhus, Дания, 8000 Aarhus C
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      • Dk-2730 Herlev, Дания, 2730
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      • Odense C, Дания, 5000
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  • Израиль
      • Haifa, Израиль, 31096
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      • Jerusalem, Израиль, 91120
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      • Petach-Tikva, Израиль, 49100
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      • Rehovot, Израиль, 76100
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      • Tel Aviv, Израиль, 64239
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      • Zrifin, Израиль, 70300
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  • Ирландия
      • Cork, Ирландия
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      • Dublin, Ирландия, 7
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      • Dublin, Ирландия, 9
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      • Galway, Ирландия
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      • Tallaght, Dublin, Ирландия, 24
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  • Испания
      • Badalona, Испания, 08916
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      • Barcelona, Испания, 08035
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      • Cordoba, Испания, 14004
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      • Dos Hermanas (Sevilla), Испания, 41700
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      • Madrid, Испания, 28041
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      • Madrid, Испания, 28007
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      • Madrid, Испания, 28033
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      • Madrid, Испания, 28050
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      • Malaga, Испания, 29010
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      • Oviedo, Испания, 33006
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      • Sevilla, Испания, 41013
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      • Valencia, Испания, 46009
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  • Италия
    • Campania
      • Napoli, Campania, Италия, 80131
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    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Италия, 40138
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      • Meldola (FC), Emilia-Romagna, Италия, 47014
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      • Modena, Emilia-Romagna, Италия, 41100
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    • Lazio
      • Roma, Lazio, Италия, 00144
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      • Roma, Lazio, Италия, 00152
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    • Lombardia
      • Milano, Lombardia, Италия, 20133
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      • Rozzano (MI), Lombardia, Италия, 20089
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    • Piemonte
      • Candiolo (TO), Piemonte, Италия, 10060
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    • Toscana
      • Arezzo, Toscana, Италия, 52100
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    • Umbria
      • Terni, Umbria, Италия, 05100
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    • Veneto
      • Negrar, Veneto, Италия, 37024
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  • Канада
      • Quebec, Канада, G1R 2J6
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    • Alberta
      • Calgary, Alberta, Канада, T2N 4N2
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      • Edmonton, Alberta, Канада, T6G 1Z2
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    • British Columbia
      • Vancouver, British Columbia, Канада, V5Z 1M9
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    • New Brunswick
      • Moncton, New Brunswick, Канада, E1C 6Z8
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    • Nova Scotia
      • Halifax, Nova Scotia, Канада, B3H 1V7
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    • Ontario
      • Hamilton, Ontario, Канада, L8V 5C2
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      • London, Ontario, Канада, N6A 4L6
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      • Oshawa, Ontario, Канада, L1G 2B9
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      • Ottawa, Ontario, Канада, K1H 8L6
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      • Toronto, Ontario, Канада, M5G 2M9
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      • Toronto, Ontario, Канада, M4N 3M5
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    • Quebec
      • Montreal, Quebec, Канада, H2L 4M1
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  • Китай
      • Beijing, Китай, 100021
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      • Beijing, Китай, 100034
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      • Beijing, Китай, 100191
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      • Beijing, Китай, 100853
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      • Shanghai, Китай, 200032
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      • Shanghai, Китай, 200127
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      • Shanghai, Китай, 200025
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      • Shanghai, Китай, 200040
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      • Tianjin, Китай, 300060
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    • Hubei
      • Wuhan, Hubei, Китай, 430030
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    • Zhejiang
      • Hangzhou, Zhejiang, Китай, 310009
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      • Hangzhou, Zhejiang, Китай, 310003
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  • Корея, Республика
      • Daejeon, Корея, Республика, 35015
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      • Goyang-si, Gyeonggi-do, Корея, Республика, 410-769
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      • Jeonju-si, Корея, Республика, 54907
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      • Seongnam-si Gyeonggi-do, Корея, Республика, 13620
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      • Seoul, Корея, Республика, 03080
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      • Seoul, Корея, Республика, 06351
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      • Seoul, Корея, Республика, 120-752
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      • Seoul, Корея, Республика, 136-705
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      • Songpa-gu, Seoul, Корея, Республика, 138-736
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  • Люксембург
      • Luxembourg, Люксембург, 1210
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      • Gdansk, Польша, 80-219
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      • Krakow, Польша, 31-108
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      • Krakow, Польша, 31-115
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      • Lublin, Польша, 20-090
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      • Warszawa, Польша, 02-781
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      • Warszawa, Польша, 04-125
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      • Warszawa, Польша, 02-776
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      • Wroclaw, Польша, 50-556
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  • Российская Федерация
      • Arkhangelsk, Российская Федерация, 163045
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      • Chelyabinsk, Российская Федерация, 454087
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      • Ekaterinburg, Российская Федерация, 620102
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      • Kazan, Российская Федерация, 420029
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      • Moscow, Российская Федерация, 115478
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      • Moscow, Российская Федерация, 117997
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      • Obninsk, Российская Федерация, 249036
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      • St. Petersburg, Российская Федерация, 197758
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  • Соединенные Штаты
    • Arkansas
      • Jonesboro, Arkansas, Соединенные Штаты, 72401
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      • Indianapolis, Indiana, Соединенные Штаты, 46202
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      • Boston, Massachusetts, Соединенные Штаты, 02115
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    • Michigan
      • Detroit, Michigan, Соединенные Штаты, 48201
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      • Rochester, Minnesota, Соединенные Штаты, 55905
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      • Saint Louis, Missouri, Соединенные Штаты, 63110
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, Соединенные Штаты, 68510
        • Novartis Investigative Site
      • Omaha, Nebraska, Соединенные Штаты, 68114
        • Novartis Investigative Site
      • Omaha, Nebraska, Соединенные Штаты, 68118
        • Novartis Investigative Site
    • Nevada
      • Las Vegas, Nevada, Соединенные Штаты, 89169
        • Novartis Investigative Site
    • New Jersey
      • Hackensack, New Jersey, Соединенные Штаты, 07601
        • Novartis Investigative Site
    • New York
      • Albany, New York, Соединенные Штаты, 12206
        • Novartis Investigative Site
      • Buffalo, New York, Соединенные Штаты, 14263
        • Novartis Investigative Site
      • New York, New York, Соединенные Штаты, 10003
        • Novartis Investigative Site
      • New York, New York, Соединенные Штаты, 10021
        • Novartis Investigative Site
      • New York, New York, Соединенные Штаты, 10065
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, Соединенные Штаты, 27710
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, Соединенные Штаты, 45242
        • Novartis Investigative Site
      • Cleveland, Ohio, Соединенные Штаты, 44195
        • Novartis Investigative Site
      • Columbus, Ohio, Соединенные Штаты, 43210
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, Соединенные Штаты, 97213
        • Novartis Investigative Site
      • Springfield, Oregon, Соединенные Штаты, 97477
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19107
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19111
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19104
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19106
        • Novartis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, Соединенные Штаты, 02903
        • Novartis Investigative Site
      • Providence, Rhode Island, Соединенные Штаты, 02906
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Соединенные Штаты, 29425
        • Novartis Investigative Site
    • Tennessee
      • Chattanooga, Tennessee, Соединенные Штаты, 37404
        • Novartis Investigative Site
      • Memphis, Tennessee, Соединенные Штаты, 38120
        • Novartis Investigative Site
      • Nashville, Tennessee, Соединенные Штаты, 37203
        • Novartis Investigative Site
      • Nashville, Tennessee, Соединенные Штаты, 37232
        • Novartis Investigative Site
    • Texas
      • Bedford, Texas, Соединенные Штаты, 76022
        • Novartis Investigative Site
      • Dallas, Texas, Соединенные Штаты, 75246
        • Novartis Investigative Site
      • Houston, Texas, Соединенные Штаты, 77030
        • Novartis Investigative Site
      • Houston, Texas, Соединенные Штаты, 77024
        • Novartis Investigative Site
      • San Antonio, Texas, Соединенные Штаты, 78217
        • Novartis Investigative Site
      • Tyler, Texas, Соединенные Штаты, 75702
        • Novartis Investigative Site
    • Virginia
      • Hampton, Virginia, Соединенные Штаты, 23666
        • Novartis Investigative Site
      • Richmond, Virginia, Соединенные Штаты, 23230
        • Novartis Investigative Site
      • Virginia Beach, Virginia, Соединенные Штаты, 23462
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, Соединенные Штаты, 98109
        • Novartis Investigative Site
  • Турция
      • Ankara, Турция, 06100
        • Novartis Investigative Site
      • Ankara, Турция, 06590
        • Novartis Investigative Site
      • Istanbul, Турция, 34390
        • Novartis Investigative Site
      • Izmir, Турция, 35100
        • Novartis Investigative Site
  • Франция
      • ANGERS Cedex 2, Франция, 49055
        • Novartis Investigative Site
      • Besancon cedex, Франция, 25030
        • Novartis Investigative Site
      • Bordeaux, Франция, 33075
        • Novartis Investigative Site
      • Caen Cedex, Франция, 14076
        • Novartis Investigative Site
      • Hyeres, Франция, 83400
        • Novartis Investigative Site
      • Le Mans, Франция, 72000
        • Novartis Investigative Site
      • Marseille cedex 5, Франция, 13385
        • Novartis Investigative Site
      • Montpellier Cedex 5, Франция, 34295
        • Novartis Investigative Site
      • Paris, Франция, 75014
        • Novartis Investigative Site
      • Paris Cedex 15, Франция, 75908
        • Novartis Investigative Site
      • Poitiers Cedex, Франция, 86021
        • Novartis Investigative Site
      • Reims, Франция, 51100
        • Novartis Investigative Site
      • Rennes, Франция, 35042
        • Novartis Investigative Site
      • Saint Herblain, Франция, 44805
        • Novartis Investigative Site
      • Strasbourg Cedex, Франция, 67091
        • Novartis Investigative Site
      • Strasbourg cedex, Франция, 67085
        • Novartis Investigative Site
      • Toulouse, Франция, 31076
        • Novartis Investigative Site
      • Tours Cedex 9, Франция, 37044
        • Novartis Investigative Site
  • Чехия
      • Brno, Чехия, 656 53
        • Novartis Investigative Site
      • Brno, Чехия, 656 91
        • Novartis Investigative Site
      • Hradec Kralove, Чехия, 500 05
        • Novartis Investigative Site
      • Novy Jicin, Чехия, 741 01
        • Novartis Investigative Site
      • Olomouc, Чехия, 775 20
        • Novartis Investigative Site
      • Ostrava - Poruba, Чехия, 708 52
        • Novartis Investigative Site
      • Plzen, Чехия, 304 60
        • Novartis Investigative Site
      • Praha 2, Чехия, 12808
        • Novartis Investigative Site
      • Praha 8, Чехия, 180 00
        • Novartis Investigative Site
      • Usti nad Labem, Чехия, 40113
        • Novartis Investigative Site
  • Чили
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Чили, 7500921
        • Novartis Investigative Site
    • Valparaíso
      • Vina del Mar, Valparaíso, Чили, 254-0364
        • Novartis Investigative Site
  • Япония
      • Fukuoka, Япония, 812-8582
        • Novartis Investigative Site
      • Hokkaido, Япония, 060-8543
        • Novartis Investigative Site
      • Hokkaido, Япония, 060-8648
        • Novartis Investigative Site
      • Kanagawa, Япония, 236-0004
        • Novartis Investigative Site
      • Okayama, Япония, 700-8558
        • Novartis Investigative Site
      • Osaka, Япония, 589-8511
        • Novartis Investigative Site
      • Shizuoka, Япония, 431-3192
        • Novartis Investigative Site
      • Tokyo, Япония, 162-8666
        • Novartis Investigative Site
      • Tokyo, Япония, 113-8603
        • Novartis Investigative Site
      • Tokyo, Япония, 160-8582
        • Novartis Investigative Site
      • Yamagata, Япония, 990-9585
        • Novartis Investigative Site

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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).

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Лекарство: 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.
Другие имена:
  • PZP034
Лекарство: pazopanib
Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
Другие имена:
  • Вотриент
Плацебо Компаратор: 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.
Лекарство: 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.
Лекарство: placebo
placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Временное ограничение: 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
Временное ограничение: yearly for 4 years
yearly for 4 years
DFS With Pazopanib vs. Placebo
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: yearly for 4 years
yearly for 4 years
DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Novartis Pharmaceuticals

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

30 ноября 2010 г.

Первичное завершение (Действительный)

15 октября 2015 г.

Завершение исследования (Действительный)

15 апреля 2019 г.

Даты регистрации исследования

Первый отправленный

14 октября 2010 г.

Впервые представлено, что соответствует критериям контроля качества

4 ноября 2010 г.

Первый опубликованный (Оценивать)

7 ноября 2010 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

23 ноября 2020 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

29 октября 2020 г.

Последняя проверка

1 октября 2020 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 113387
  • 2010-020965-26 (Номер EudraCT)
  • CPZP034D2301 (Другой идентификатор: Novartis)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана 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

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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