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

29 de outubro de 2020 atualizado por: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The primary objective of this ongoing study was to evaluate DFS with pazopanib 600 mg daily initial dose as compared with placebo as adjuvant therapy for subjects with localized/locally advanced RCC following nephrectomy.

Subjects with locally recurrent renal cell carcinoma (RCC), bilateral RCC, or history of another malignancy were excluded from enrolling in the study.

The study was comprised of three successive study periods: 1) the Screening/Baseline period, 2) the study treatment period, and 3) the DFS /OS follow-up period. The Screening/Baseline period had a maximum duration of 12 weeks from the date of nephrectomy to the date of randomization.

After a subject met all the eligibility criteria and completed all the required baseline assessments, the subject was randomized in a 1:1 ratio to receive once daily blinded treatment with either pazopanib 600 mg as initial dose or matching placebo based on pre-defined stratification factors.

Subjects received continuous daily treatment until completion of the 12-month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed. During the study treatment and DFS follow-up periods, subjects received routine safety and efficacy assessments.

The study treatment period was 12 months. Subjects received continuous daily treatment until completion of the 12 month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed.

All subjects, regardless of study treatment status (i.e. premature discontinuation or completion of the 12-month treatment), were to be followed with routine imaging assessments and remain blinded until objective evidence of disease recurrence was obtained or until the study achieved the required number of events for the primary endpoint of DFS (319 events). After objective evidence of disease recurrence was obtained, subjects could be unblinded and received the first-line treatment for metastatic RCC per local standard of care.

All subjects were off treatment for at least 4 years at the end of study.

Tipo de estudo

Intervencional

Inscrição (Real)

1538

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 10967
        • Novartis Investigative Site
      • Berlin, Alemanha, 12200
        • Novartis Investigative Site
      • Berlin, Alemanha, 10719
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      • Bremen, Alemanha, 28177
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      • Hamburg, Alemanha, 20246
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    • Baden-Wuerttemberg
      • Kirchheim, Baden-Wuerttemberg, Alemanha, 73230
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      • Ravensburg, Baden-Wuerttemberg, Alemanha, 88212
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      • Sigmaringen, Baden-Wuerttemberg, Alemanha, 72488
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      • Stuttgart, Baden-Wuerttemberg, Alemanha, 70174
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      • Tuebingen, Baden-Wuerttemberg, Alemanha, 72076
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      • Ulm, Baden-Wuerttemberg, Alemanha, 89075
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      • Muenchen, Bayern, Alemanha, 81675
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      • Wuhan, Hubei, China, 430030
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      • Hangzhou, Zhejiang, China, 310009
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      • Hangzhou, Zhejiang, China, 310003
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  • Dinamarca
      • Aarhus, Dinamarca, 8000 Aarhus C
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      • Dk-2730 Herlev, Dinamarca, 2730
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      • Odense C, Dinamarca, 5000
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  • Eslováquia
      • Banska Bystrica, Eslováquia, 975 17
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      • Martin, Eslováquia, 036 59
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  • Espanha
      • Badalona, Espanha, 08916
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      • Barcelona, Espanha, 08035
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      • Cordoba, Espanha, 14004
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      • Dos Hermanas (Sevilla), Espanha, 41700
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      • Madrid, Espanha, 28041
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      • Madrid, Espanha, 28007
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      • Madrid, Espanha, 28033
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      • Malaga, Espanha, 29010
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      • Sevilla, Espanha, 41013
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      • Valencia, Espanha, 46009
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  • Estados Unidos
    • Arkansas
      • Jonesboro, Arkansas, Estados Unidos, 72401
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    • California
      • Antioch, California, Estados Unidos, 94531
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      • Beverly Hills, California, Estados Unidos, 90211
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      • Fresno, California, Estados Unidos, 93720
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      • La Jolla, California, Estados Unidos, 92093
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      • Los Angeles, California, Estados Unidos, 90033
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      • Los Angeles, California, Estados Unidos, 90095
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      • Los Angeles, California, Estados Unidos, 90048-0750
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      • Oakland, California, Estados Unidos, 94611
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      • Sacramento, California, Estados Unidos, 95825
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      • San Francisco, California, Estados Unidos, 94115
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      • South San Francisco, California, Estados Unidos, 94080
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      • Stanford, California, Estados Unidos, 94305
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      • Vallejo, California, Estados Unidos, 94589
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    • Colorado
      • Fort Collins, Colorado, Estados Unidos, 80528
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    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20007
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    • Florida
      • Fort Myers, Florida, Estados Unidos, 33916
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      • Tampa, Florida, Estados Unidos, 33612
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    • Georgia
      • Athens, Georgia, Estados Unidos, 30607
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      • Macon, Georgia, Estados Unidos, 31201
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    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
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    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
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    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
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    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21231
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    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
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      • Boston, Massachusetts, Estados Unidos, 02115
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      • Boston, Massachusetts, Estados Unidos, 02215
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      • Burlington, Massachusetts, Estados Unidos, 01805
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    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
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    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
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      • Saint Louis Park, Minnesota, Estados Unidos, 55416
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    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
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    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68510
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      • Omaha, Nebraska, Estados Unidos, 68114
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      • Omaha, Nebraska, Estados Unidos, 68118
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    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89169
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      • Hackensack, New Jersey, Estados Unidos, 07601
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      • Albany, New York, Estados Unidos, 12206
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      • Buffalo, New York, Estados Unidos, 14263
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      • New York, New York, Estados Unidos, 10003
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      • New York, New York, Estados Unidos, 10021
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    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
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      • Cincinnati, Ohio, Estados Unidos, 45242
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      • Cleveland, Ohio, Estados Unidos, 44195
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      • Columbus, Ohio, Estados Unidos, 43210
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      • Portland, Oregon, Estados Unidos, 97213
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      • Philadelphia, Pennsylvania, Estados Unidos, 19107
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      • Philadelphia, Pennsylvania, Estados Unidos, 19111
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      • Providence, Rhode Island, Estados Unidos, 02903
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      • Charleston, South Carolina, Estados Unidos, 29425
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      • Chattanooga, Tennessee, Estados Unidos, 37404
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      • Nashville, Tennessee, Estados Unidos, 37203
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      • Nashville, Tennessee, Estados Unidos, 37232
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    • Virginia
      • Hampton, Virginia, Estados Unidos, 23666
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      • Seattle, Washington, Estados Unidos, 98109
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  • Federação Russa
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      • Roma, Lazio, Itália, 00144
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      • Milano, Lombardia, Itália, 20133
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      • Candiolo (TO), Piemonte, Itália, 10060
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      • Terni, Umbria, Itália, 05100
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    • Veneto
      • Negrar, Veneto, Itália, 37024
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  • Japão
      • Fukuoka, Japão, 812-8582
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  • Luxemburgo
      • Luxembourg, Luxemburgo, 1210
        • Novartis Investigative Site
  • Peru
      • Ankara, Peru, 06100
        • Novartis Investigative Site
      • Ankara, Peru, 06590
        • Novartis Investigative Site
      • Istanbul, Peru, 34390
        • Novartis Investigative Site
      • Izmir, Peru, 35100
        • Novartis Investigative Site
  • Polônia
      • Gdansk, Polônia, 80-219
        • Novartis Investigative Site
      • Konin, Polônia, 62-500
        • Novartis Investigative Site
      • Krakow, Polônia, 31-108
        • Novartis Investigative Site
      • Krakow, Polônia, 31-115
        • Novartis Investigative Site
      • Lublin, Polônia, 20-090
        • Novartis Investigative Site
      • Warszawa, Polônia, 02-781
        • Novartis Investigative Site
      • Warszawa, Polônia, 04-125
        • Novartis Investigative Site
      • Warszawa, Polônia, 02-776
        • Novartis Investigative Site
      • Wroclaw, Polônia, 50-556
        • Novartis Investigative Site
  • Reino Unido
      • Brighton, Reino Unido, BN2 5BE
        • Novartis Investigative Site
      • Cornwall, Reino Unido, TR1 3LJ
        • Novartis Investigative Site
      • Guildford, Reino Unido, GU2 7XX
        • Novartis Investigative Site
      • London, Reino Unido, SE1 9RT
        • Novartis Investigative Site
      • London, Reino Unido, NW3 2QG
        • Novartis Investigative Site
      • Manchester, Reino Unido, M20 4BX
        • Novartis Investigative Site
      • Preston, Reino Unido, PR2 9HT
        • Novartis Investigative Site
      • Swansea, Reino Unido, SA2 8QA
        • Novartis Investigative Site
      • Wolverhampton, Reino Unido, WV10 0QP
        • Novartis Investigative Site
  • Republica da Coréia
      • Daejeon, Republica da Coréia, 35015
        • Novartis Investigative Site
      • Goyang-si, Gyeonggi-do, Republica da Coréia, 410-769
        • Novartis Investigative Site
      • Jeonju-si, Republica da Coréia, 54907
        • Novartis Investigative Site
      • Seongnam-si Gyeonggi-do, Republica da Coréia, 13620
        • Novartis Investigative Site
      • Seoul, Republica da Coréia, 03080
        • Novartis Investigative Site
      • Seoul, Republica da Coréia, 06351
        • Novartis Investigative Site
      • Seoul, Republica da Coréia, 120-752
        • Novartis Investigative Site
      • Seoul, Republica da Coréia, 136-705
        • Novartis Investigative Site
      • Songpa-gu, Seoul, Republica da Coréia, 138-736
        • Novartis Investigative Site
  • Tcheca
      • Brno, Tcheca, 656 53
        • Novartis Investigative Site
      • Brno, Tcheca, 656 91
        • Novartis Investigative Site
      • Hradec Kralove, Tcheca, 500 05
        • Novartis Investigative Site
      • Novy Jicin, Tcheca, 741 01
        • Novartis Investigative Site
      • Olomouc, Tcheca, 775 20
        • Novartis Investigative Site
      • Ostrava - Poruba, Tcheca, 708 52
        • Novartis Investigative Site
      • Plzen, Tcheca, 304 60
        • Novartis Investigative Site
      • Praha 2, Tcheca, 12808
        • Novartis Investigative Site
      • Praha 8, Tcheca, 180 00
        • Novartis Investigative Site
      • Usti nad Labem, Tcheca, 40113
        • Novartis Investigative Site
  • Áustria
      • Graz, Áustria, 8036
        • Novartis Investigative Site
      • Innsbruck, Áustria, 6020
        • Novartis Investigative Site
      • Salzburg, Áustria, 5020
        • Novartis Investigative Site
      • Salzburg, Áustria, A-5020
        • Novartis Investigative Site
      • Vienna, Áustria, A-1090
        • Novartis Investigative Site
      • Vienna, Áustria, 1130
        • Novartis Investigative Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: pazopanib
Pazopanib oral agent, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.
Medicamento: 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.
Outros nomes:
  • PZP034
Medicamento: pazopanib
Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
Outros nomes:
  • Votrient
Comparador de Placebo: 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.
Medicamento: 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.
Medicamento: placebo
placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Prazo: approximately 5 years
DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.
approximately 5 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Prazo: 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
Prazo: yearly for 4 years
yearly for 4 years
DFS With Pazopanib vs. Placebo
Prazo: 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
Prazo: 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
Prazo: yearly for 4 years
yearly for 4 years
DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU
Health outcome and quality of life measured by using EQ-5D thermometer score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Week 52, 24M DFS FU, 36M DFS FU, 48M DFS FU, 54M DFS FU

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

30 de novembro de 2010

Conclusão Primária (Real)

15 de outubro de 2015

Conclusão do estudo (Real)

15 de abril de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

14 de outubro de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de novembro de 2010

Primeira postagem (Estimativa)

7 de novembro de 2010

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de novembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de outubro de 2020

Última verificação

1 de outubro de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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