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

2020年10月29日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

1538

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アイルランド
      • Cork、アイルランド
        • Novartis Investigative Site
      • Dublin、アイルランド、7
        • Novartis Investigative Site
      • Dublin、アイルランド、9
        • Novartis Investigative Site
      • Galway、アイルランド
        • Novartis Investigative Site
      • Tallaght, Dublin、アイルランド、24
        • Novartis Investigative Site
  • アメリカ
    • Arkansas
      • Jonesboro、Arkansas、アメリカ、72401
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    • California
      • Antioch、California、アメリカ、94531
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      • Beverly Hills、California、アメリカ、90211
        • Novartis Investigative Site
      • Fresno、California、アメリカ、93720
        • Novartis Investigative Site
      • La Jolla、California、アメリカ、92093
        • Novartis Investigative Site
      • Los Angeles、California、アメリカ、90033
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      • Los Angeles、California、アメリカ、90095
        • Novartis Investigative Site
      • Los Angeles、California、アメリカ、90048-0750
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      • Oakland、California、アメリカ、94611
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      • Sacramento、California、アメリカ、95825
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      • San Francisco、California、アメリカ、94115
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      • South San Francisco、California、アメリカ、94080
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      • Stanford、California、アメリカ、94305
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      • Vallejo、California、アメリカ、94589
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    • Colorado
      • Fort Collins、Colorado、アメリカ、80528
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    • District of Columbia
      • Washington、District of Columbia、アメリカ、20007
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    • Florida
      • Fort Myers、Florida、アメリカ、33916
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      • Tampa、Florida、アメリカ、33612
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    • Georgia
      • Athens、Georgia、アメリカ、30607
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      • Macon、Georgia、アメリカ、31201
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      • Chicago、Illinois、アメリカ、60637
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    • Indiana
      • Indianapolis、Indiana、アメリカ、46202
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    • Iowa
      • Iowa City、Iowa、アメリカ、52242
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    • Maryland
      • Baltimore、Maryland、アメリカ、21231
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      • Boston、Massachusetts、アメリカ、02114
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      • Boston、Massachusetts、アメリカ、02115
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      • Boston、Massachusetts、アメリカ、02215
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      • Burlington、Massachusetts、アメリカ、01805
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    • Michigan
      • Detroit、Michigan、アメリカ、48201
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    • Minnesota
      • Rochester、Minnesota、アメリカ、55905
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      • Saint Louis Park、Minnesota、アメリカ、55416
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    • Missouri
      • Saint Louis、Missouri、アメリカ、63110
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      • Lincoln、Nebraska、アメリカ、68510
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      • Omaha、Nebraska、アメリカ、68114
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      • Omaha、Nebraska、アメリカ、68118
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      • Las Vegas、Nevada、アメリカ、89169
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    • New Jersey
      • Hackensack、New Jersey、アメリカ、07601
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      • Albany、New York、アメリカ、12206
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      • Buffalo、New York、アメリカ、14263
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      • New York、New York、アメリカ、10003
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      • New York、New York、アメリカ、10021
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      • New York、New York、アメリカ、10065
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    • North Carolina
      • Durham、North Carolina、アメリカ、27710
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    • Ohio
      • Cincinnati、Ohio、アメリカ、45242
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      • Cleveland、Ohio、アメリカ、44195
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      • Columbus、Ohio、アメリカ、43210
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      • Portland、Oregon、アメリカ、97213
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      • Philadelphia、Pennsylvania、アメリカ、19107
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      • Philadelphia、Pennsylvania、アメリカ、19106
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    • Rhode Island
      • Providence、Rhode Island、アメリカ、02903
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      • Providence、Rhode Island、アメリカ、02906
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      • Charleston、South Carolina、アメリカ、29425
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    • Tennessee
      • Chattanooga、Tennessee、アメリカ、37404
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      • Memphis、Tennessee、アメリカ、38120
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      • Nashville、Tennessee、アメリカ、37203
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      • Nashville、Tennessee、アメリカ、37232
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      • Bedford、Texas、アメリカ、76022
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      • Hampton、Virginia、アメリカ、23666
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      • Seattle、Washington、アメリカ、98109
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      • Berazategui、Buenos Aires、アルゼンチン、B1880BBF
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      • Capital Federal、Buenos Aires、アルゼンチン、C1426ANZ
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      • Ciudad Aut6noma de Buenos Aires、Buenos Aires、アルゼンチン、C1050AAK
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      • Cordoba、Córdova、アルゼンチン、X5006HBF
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      • Cordoba、Córdova、アルゼンチン、X5003DCE
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      • Cipolletti、Río Negro、アルゼンチン、R8324EMB
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    • Santa Fe
      • Rosario、Santa Fe、アルゼンチン、S2000KZE
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  • イギリス
      • Brighton、イギリス、BN2 5BE
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      • Cornwall、イギリス、TR1 3LJ
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      • Guildford、イギリス、GU2 7XX
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      • London、イギリス、SE1 9RT
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      • London、イギリス、NW3 2QG
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      • Manchester、イギリス、M20 4BX
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      • Preston、イギリス、PR2 9HT
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      • Swansea、イギリス、SA2 8QA
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      • Wolverhampton、イギリス、WV10 0QP
        • Novartis Investigative Site
  • イスラエル
      • Haifa、イスラエル、31096
        • Novartis Investigative Site
      • Jerusalem、イスラエル、91120
        • Novartis Investigative Site
      • Petach-Tikva、イスラエル、49100
        • Novartis Investigative Site
      • Rehovot、イスラエル、76100
        • Novartis Investigative Site
      • Tel Aviv、イスラエル、64239
        • Novartis Investigative Site
      • Zrifin、イスラエル、70300
        • Novartis Investigative Site
  • イタリア
    • Campania
      • Napoli、Campania、イタリア、80131
        • Novartis Investigative Site
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、イタリア、40138
        • Novartis Investigative Site
      • Meldola (FC)、Emilia-Romagna、イタリア、47014
        • Novartis Investigative Site
      • Modena、Emilia-Romagna、イタリア、41100
        • Novartis Investigative Site
    • Lazio
      • Roma、Lazio、イタリア、00144
        • Novartis Investigative Site
      • Roma、Lazio、イタリア、00152
        • Novartis Investigative Site
    • Lombardia
      • Milano、Lombardia、イタリア、20133
        • Novartis Investigative Site
      • Rozzano (MI)、Lombardia、イタリア、20089
        • Novartis Investigative Site
    • Piemonte
      • Candiolo (TO)、Piemonte、イタリア、10060
        • Novartis Investigative Site
    • Toscana
      • Arezzo、Toscana、イタリア、52100
        • Novartis Investigative Site
    • Umbria
      • Terni、Umbria、イタリア、05100
        • Novartis Investigative Site
    • Veneto
      • Negrar、Veneto、イタリア、37024
        • Novartis Investigative Site
  • オーストリア
      • Graz、オーストリア、8036
        • Novartis Investigative Site
      • Innsbruck、オーストリア、6020
        • Novartis Investigative Site
      • Salzburg、オーストリア、5020
        • Novartis Investigative Site
      • Salzburg、オーストリア、A-5020
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      • Vienna、オーストリア、A-1090
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      • Vienna、オーストリア、1130
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  • カナダ
      • Quebec、カナダ、G1R 2J6
        • Novartis Investigative Site
    • Alberta
      • Calgary、Alberta、カナダ、T2N 4N2
        • Novartis Investigative Site
      • Edmonton、Alberta、カナダ、T6G 1Z2
        • Novartis Investigative Site
    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 1M9
        • Novartis Investigative Site
    • New Brunswick
      • Moncton、New Brunswick、カナダ、E1C 6Z8
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3H 1V7
        • Novartis Investigative Site
    • Ontario
      • Hamilton、Ontario、カナダ、L8V 5C2
        • Novartis Investigative Site
      • London、Ontario、カナダ、N6A 4L6
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      • Oshawa、Ontario、カナダ、L1G 2B9
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      • Ottawa、Ontario、カナダ、K1H 8L6
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      • Toronto、Ontario、カナダ、M5G 2M9
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      • Toronto、Ontario、カナダ、M4N 3M5
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    • Quebec
      • Montreal、Quebec、カナダ、H2L 4M1
        • Novartis Investigative Site
  • ギリシャ
      • Athens、ギリシャ、115 22
        • Novartis Investigative Site
      • Heraklion, Crete、ギリシャ、71100
        • Novartis Investigative Site
      • Patra、ギリシャ、26504
        • Novartis Investigative Site
      • Thessaloniki、ギリシャ
        • Novartis Investigative Site
  • スペイン
      • Badalona、スペイン、08916
        • Novartis Investigative Site
      • Barcelona、スペイン、08035
        • Novartis Investigative Site
      • Cordoba、スペイン、14004
        • Novartis Investigative Site
      • Dos Hermanas (Sevilla)、スペイン、41700
        • Novartis Investigative Site
      • Madrid、スペイン、28041
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      • Madrid、スペイン、28007
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      • Madrid、スペイン、28033
        • Novartis Investigative Site
      • Madrid、スペイン、28050
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      • Malaga、スペイン、29010
        • Novartis Investigative Site
      • Oviedo、スペイン、33006
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      • Sevilla、スペイン、41013
        • Novartis Investigative Site
      • Valencia、スペイン、46009
        • Novartis Investigative Site
  • スロバキア
      • Banska Bystrica、スロバキア、975 17
        • Novartis Investigative Site
      • Bratislava、スロバキア、833 05
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      • Kosice、スロバキア、041 66
        • Novartis Investigative Site
      • Martin、スロバキア、036 59
        • Novartis Investigative Site
      • Zilina、スロバキア、012 07
        • Novartis Investigative Site
  • チェコ
      • Brno、チェコ、656 53
        • Novartis Investigative Site
      • Brno、チェコ、656 91
        • Novartis Investigative Site
      • Hradec Kralove、チェコ、500 05
        • Novartis Investigative Site
      • Novy Jicin、チェコ、741 01
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      • Olomouc、チェコ、775 20
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      • Ostrava - Poruba、チェコ、708 52
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      • Plzen、チェコ、304 60
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      • Praha 2、チェコ、12808
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      • Praha 8、チェコ、180 00
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      • Usti nad Labem、チェコ、40113
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  • チリ
    • Región Metro De Santiago
      • Santiago、Región Metro De Santiago、チリ、7500921
        • Novartis Investigative Site
    • Valparaíso
      • Vina del Mar、Valparaíso、チリ、254-0364
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  • デンマーク
      • Aarhus、デンマーク、8000 Aarhus C
        • Novartis Investigative Site
      • Dk-2730 Herlev、デンマーク、2730
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      • Odense C、デンマーク、5000
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  • ドイツ
      • Berlin、ドイツ、10967
        • Novartis Investigative Site
      • Berlin、ドイツ、12200
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      • Berlin、ドイツ、10719
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      • Bremen、ドイツ、28177
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      • Hamburg、ドイツ、20246
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    • Baden-Wuerttemberg
      • Kirchheim、Baden-Wuerttemberg、ドイツ、73230
        • Novartis Investigative Site
      • Ravensburg、Baden-Wuerttemberg、ドイツ、88212
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      • Sigmaringen、Baden-Wuerttemberg、ドイツ、72488
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      • Stuttgart、Baden-Wuerttemberg、ドイツ、70174
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      • Tuebingen、Baden-Wuerttemberg、ドイツ、72076
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      • Ulm、Baden-Wuerttemberg、ドイツ、89075
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    • Bayern
      • Erlangen、Bayern、ドイツ、91054
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      • Fuerth、Bayern、ドイツ、90766
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      • Muenchen、Bayern、ドイツ、81675
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      • Regensburg、Bayern、ドイツ、93053
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      • Weiden、Bayern、ドイツ、92637
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    • Hessen
      • Frankfurt、Hessen、ドイツ、60590
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      • Marburg、Hessen、ドイツ、35043
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    • Niedersachsen
      • Braunschweig、Niedersachsen、ドイツ、38126
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      • Hannover、Niedersachsen、ドイツ、30625
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    • Nordrhein-Westfalen
      • Aachen、Nordrhein-Westfalen、ドイツ、52074
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      • Bergisch Gladbach、Nordrhein-Westfalen、ドイツ、51465
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      • Bonn、Nordrhein-Westfalen、ドイツ、53127
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      • Muenster、Nordrhein-Westfalen、ドイツ、48149
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      • Neuss、Nordrhein-Westfalen、ドイツ、41464
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      • Velbert、Nordrhein-Westfalen、ドイツ、42551
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    • Rheinland-Pfalz
      • Mainz、Rheinland-Pfalz、ドイツ、55131
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    • Saarland
      • Homburg、Saarland、ドイツ、66421
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      • Chemnitz、Sachsen、ドイツ、09130
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    • Sachsen-Anhalt
      • Dessau、Sachsen-Anhalt、ドイツ、06846
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      • Eisleben、Sachsen-Anhalt、ドイツ、06295
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      • Halle、Sachsen-Anhalt、ドイツ、06120
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    • Schleswig-Holstein
      • Luebeck、Schleswig-Holstein、ドイツ、23566
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      • Jena、Thueringen、ドイツ、07768
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  • ハンガリー
      • Budapest、ハンガリー、1082
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      • Budapest、ハンガリー、1097
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      • Budapest、ハンガリー、1122
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      • Miskolc、ハンガリー、3526
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      • Nyiregyhaza、ハンガリー、4400
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      • Szombathely、ハンガリー、9700
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  • フランス
      • ANGERS Cedex 2、フランス、49055
        • Novartis Investigative Site
      • Besancon cedex、フランス、25030
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      • Bordeaux、フランス、33075
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      • Caen Cedex、フランス、14076
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      • Hyeres、フランス、83400
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      • Le Mans、フランス、72000
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      • Marseille cedex 5、フランス、13385
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      • Montpellier Cedex 5、フランス、34295
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      • Paris、フランス、75014
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      • Paris Cedex 15、フランス、75908
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      • Poitiers Cedex、フランス、86021
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      • Reims、フランス、51100
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      • Rennes、フランス、35042
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      • Saint Herblain、フランス、44805
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      • Strasbourg Cedex、フランス、67091
        • Novartis Investigative Site
      • Strasbourg cedex、フランス、67085
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      • Toulouse、フランス、31076
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      • Tours Cedex 9、フランス、37044
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  • ブラジル
      • Rio de Janeiro、ブラジル、20 551-030
        • Novartis Investigative Site
      • Rio de Janeiro、ブラジル、20231-050
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    • Minas Gerais
      • Belo Horizonte、Minas Gerais、ブラジル、30130-100
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    • Paraná
      • Curitiba、Paraná、ブラジル、81520-060
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    • Rio Grande Do Sul
      • Ijui、Rio Grande Do Sul、ブラジル、98700-000
        • Novartis Investigative Site
      • Porto Alegre、Rio Grande Do Sul、ブラジル、90610000
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    • São Paulo
      • Barretos、São Paulo、ブラジル、14784-400
        • Novartis Investigative Site
      • Campinas、São Paulo、ブラジル、13083-970
        • Novartis Investigative Site
      • Sao Paulo、São Paulo、ブラジル、01246-000
        • Novartis Investigative Site
      • Sao Paulo、São Paulo、ブラジル、05651-901
        • Novartis Investigative Site
      • Sao Paulo、São Paulo、ブラジル、01308-050
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      • Wroclaw、ポーランド、50-556
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  • ルクセンブルク
      • Luxembourg、ルクセンブルク、1210
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  • ロシア連邦
      • Arkhangelsk、ロシア連邦、163045
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      • Ekaterinburg、ロシア連邦、620102
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      • Hangzhou、Zhejiang、中国、310009
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参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.
他の名前：
  • PZP034
薬：pazopanib
Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
他の名前：
  • ボトリエント
プラセボコンパレーター：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.
薬：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.
薬：placebo
placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
時間枠：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
時間枠：yearly for 4 years
yearly for 4 years
DFS With Pazopanib vs. Placebo
時間枠：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
時間枠：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
時間枠：yearly for 4 years
yearly for 4 years
DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Novartis Pharmaceuticals

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2010年11月30日

一次修了 (実際)

2015年10月15日

研究の完了 (実際)

2019年4月15日

試験登録日

最初に提出

2010年10月14日

QC基準を満たした最初の提出物

2010年11月4日

最初の投稿 (見積もり)

2010年11月7日

学習記録の更新

投稿された最後の更新 (実際)

2020年11月23日

QC基準を満たした最後の更新が送信されました

2020年10月29日

最終確認日

2020年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 113387
  • 2010-020965-26 (EudraCT番号)
  • CPZP034D2301 (その他の識別子：Novartis)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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