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Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma (COMPARZ)

19. april 2021 oppdatert av: Novartis Pharmaceuticals

Study VEG108844, A Study of Pazopanib Versus Sunitinib in the Treatment of Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma

This study is being conducted to provide a direct comparison of the efficacy, safety and tolerability for pazopanib and sunitinib (SUTENT)

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study will evaluate the efficacy and safety of pazopanib compared to sunitinib in subjects with advanced RCC who have received no prior systemic therapy for advanced or metastatic RCC. Subjects will be randomized in a 1:1 ratio to receive either 800mg pazopanib to be administered once daily orally continuous dosing or 50mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects are permitted to receive supportive care throughout the study including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoietin, or bisphosphonates, when appropriate. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdraw consent, or death.

Studietype

Intervensjonell

Registrering (Faktiske)

927

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Novartis Investigative Site
      • Kogarah, New South Wales, Australia, 2217
        • Novartis Investigative Site
      • Randwick, New South Wales, Australia, 2031
        • Novartis Investigative Site
      • Waratah, New South Wales, Australia, 2298
        • Novartis Investigative Site
      • Westmead, New South Wales, Australia, 2145
        • Novartis Investigative Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Novartis Investigative Site
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Novartis Investigative Site
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Novartis Investigative Site
      • Wodonga, Victoria, Australia, 3690
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Novartis Investigative Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Novartis Investigative Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Novartis Investigative Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Novartis Investigative Site
      • London, Ontario, Canada, N6A 4L6
        • Novartis Investigative Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Novartis Investigative Site
  • Forente stater
    • Alabama
      • Huntsville, Alabama, Forente stater, 35805
        • Novartis Investigative Site
    • Arizona
      • Tucson, Arizona, Forente stater, 85710
        • Novartis Investigative Site
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Novartis Investigative Site
    • California
      • Beverly Hills, California, Forente stater, 90211
        • Novartis Investigative Site
      • Escondido, California, Forente stater, 92025
        • Novartis Investigative Site
      • Fresno, California, Forente stater, 93720
        • Novartis Investigative Site
      • Greenbrae, California, Forente stater, 94904-2007
        • Novartis Investigative Site
      • Hayward, California, Forente stater, 94545
        • Novartis Investigative Site
      • La Jolla, California, Forente stater, 92037
        • Novartis Investigative Site
      • Los Angeles, California, Forente stater, 90095
        • Novartis Investigative Site
      • Montebello, California, Forente stater, 90640
        • Novartis Investigative Site
      • Oakland, California, Forente stater, 94611
        • Novartis Investigative Site
      • Orange, California, Forente stater, 92868
        • Novartis Investigative Site
      • Roseville, California, Forente stater, 95661
        • Novartis Investigative Site
      • Sacramento, California, Forente stater, 95817
        • Novartis Investigative Site
      • Sacramento, California, Forente stater, 95825
        • Novartis Investigative Site
      • San Bernardino, California, Forente stater, 92404
        • Novartis Investigative Site
      • San Francisco, California, Forente stater, 94115
        • Novartis Investigative Site
      • San Jose, California, Forente stater, 95119-1110
        • Novartis Investigative Site
      • Santa Clara, California, Forente stater, 95051
        • Novartis Investigative Site
      • South San Francisco, California, Forente stater, 94080
        • Novartis Investigative Site
      • Vallejo, California, Forente stater, 94589
        • Novartis Investigative Site
      • Walnut Creek, California, Forente stater, 94596
        • Novartis Investigative Site
    • Colorado
      • Denver, Colorado, Forente stater, 80218
        • Novartis Investigative Site
    • Connecticut
      • Southington, Connecticut, Forente stater, 06489
        • Novartis Investigative Site
      • Trumbull, Connecticut, Forente stater, 06611
        • Novartis Investigative Site
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20007
        • Novartis Investigative Site
    • Florida
      • Fort Myers, Florida, Forente stater, 33916
        • Novartis Investigative Site
      • Miami, Florida, Forente stater, 33136
        • Novartis Investigative Site
      • Orlando, Florida, Forente stater, 32806
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, Forente stater, 30318
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Novartis Investigative Site
      • Elk Grove Village, Illinois, Forente stater, 60007
        • Novartis Investigative Site
      • Maywood, Illinois, Forente stater, 60153
        • Novartis Investigative Site
      • Peoria, Illinois, Forente stater, 61615-7822
        • Novartis Investigative Site
    • Indiana
      • Carmel, Indiana, Forente stater, 46032
        • Novartis Investigative Site
      • Indianapolis, Indiana, Forente stater, 46202
        • Novartis Investigative Site
      • Indianapolis, Indiana, Forente stater, 46237
        • Novartis Investigative Site
    • Iowa
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40202
        • Novartis Investigative Site
      • Paducah, Kentucky, Forente stater, 42003
        • Novartis Investigative Site
    • Maryland
      • Annapolis, Maryland, Forente stater, 21401
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Novartis Investigative Site
      • Boston, Massachusetts, Forente stater, 02115
        • Novartis Investigative Site
      • Boston, Massachusetts, Forente stater, 02215
        • Novartis Investigative Site
      • Worcester, Massachusetts, Forente stater, 01608
        • Novartis Investigative Site
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Novartis Investigative Site
    • Minnesota
      • Duluth, Minnesota, Forente stater, 55805
        • Novartis Investigative Site
      • Minneapolis, Minnesota, Forente stater, 55455
        • Novartis Investigative Site
    • Mississippi
      • Tupelo, Mississippi, Forente stater, 38801
        • Novartis Investigative Site
    • Missouri
      • Kansas City, Missouri, Forente stater, 64118
        • Novartis Investigative Site
      • Kansas City, Missouri, Forente stater, 64131
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68510
        • Novartis Investigative Site
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89169
        • Novartis Investigative Site
      • Las Vegas, Nevada, Forente stater, 89135
        • Novartis Investigative Site
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Novartis Investigative Site
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Novartis Investigative Site
    • New York
      • Buffalo, New York, Forente stater, 14215
        • Novartis Investigative Site
      • New York, New York, Forente stater, 10032
        • Novartis Investigative Site
      • New York, New York, Forente stater, 10065
        • Novartis Investigative Site
    • North Carolina
      • Hickory, North Carolina, Forente stater, 28602
        • Novartis Investigative Site
      • Raleigh, North Carolina, Forente stater, 27607
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45242
        • Novartis Investigative Site
      • Cleveland, Ohio, Forente stater, 44106
        • Novartis Investigative Site
      • Columbus, Ohio, Forente stater, 43210
        • Novartis Investigative Site
      • Columbus, Ohio, Forente stater, 43219
        • Novartis Investigative Site
      • Dayton, Ohio, Forente stater, 45429
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73120
        • Novartis Investigative Site
      • Tulsa, Oklahoma, Forente stater, 74136
        • Novartis Investigative Site
    • Oregon
      • Eugene, Oregon, Forente stater, 97401
        • Novartis Investigative Site
      • Portland, Oregon, Forente stater, 97213
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19111
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, Forente stater, 19102
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Novartis Investigative Site
      • Charleston, South Carolina, Forente stater, 29403
        • Novartis Investigative Site
      • Greenville, South Carolina, Forente stater, 29605
        • Novartis Investigative Site
      • Mount Pleasant, South Carolina, Forente stater, 29464
        • Novartis Investigative Site
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37404
        • Novartis Investigative Site
      • Nashville, Tennessee, Forente stater, 37203
        • Novartis Investigative Site
    • Texas
      • Arlington, Texas, Forente stater, 76012
        • Novartis Investigative Site
      • Bedford, Texas, Forente stater, 76022
        • Novartis Investigative Site
      • Corpus Christi, Texas, Forente stater, 78463-3069
        • Novartis Investigative Site
      • Dallas, Texas, Forente stater, 75246
        • Novartis Investigative Site
      • Fort Worth, Texas, Forente stater, 76104
        • Novartis Investigative Site
      • Lubbock, Texas, Forente stater, 79410
        • Novartis Investigative Site
      • Round Rock, Texas, Forente stater, 78681
        • Novartis Investigative Site
      • San Antonio, Texas, Forente stater, 78229
        • Novartis Investigative Site
      • Tyler, Texas, Forente stater, 75702
        • Novartis Investigative Site
      • Webster, Texas, Forente stater, 77598-4420
        • Novartis Investigative Site
      • Wichita Falls, Texas, Forente stater, 76310
        • Novartis Investigative Site
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22903
        • Novartis Investigative Site
      • Hampton, Virginia, Forente stater, 23666
        • Novartis Investigative Site
      • Richmond, Virginia, Forente stater, 23230
        • Novartis Investigative Site
      • Salem, Virginia, Forente stater, 24153
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Novartis Investigative Site
      • Seattle, Washington, Forente stater, 98101
        • Novartis Investigative Site
  • Irland
      • Dublin, Irland, 7
        • Novartis Investigative Site
      • Dublin, Irland, 8
        • Novartis Investigative Site
      • Dublin, Irland, 9
        • Novartis Investigative Site
      • Galway, Irland
        • Novartis Investigative Site
      • Tallaght, Dublin, Irland, 24
        • Novartis Investigative Site
  • Italia
    • Campania
      • Napoli, Campania, Italia, 80131
        • Novartis Investigative Site
    • Emilia-Romagna
      • Meldola (FC), Emilia-Romagna, Italia, 47014
        • Novartis Investigative Site
      • Ravenna, Emilia-Romagna, Italia, 48100
        • Novartis Investigative Site
    • Friuli-Venezia-Giulia
      • Pordenone, Friuli-Venezia-Giulia, Italia, 33170
        • Novartis Investigative Site
    • Lazio
      • Roma, Lazio, Italia, 00152
        • Novartis Investigative Site
    • Lombardia
      • Milano, Lombardia, Italia, 20141
        • Novartis Investigative Site
    • Toscana
      • Arezzo, Toscana, Italia, 52100
        • Novartis Investigative Site
  • Japan
      • Ehime, Japan, 791-0280
        • Novartis Investigative Site
      • Fukuoka, Japan, 812-0033
        • Novartis Investigative Site
      • Fukuoka, Japan, 812-8582
        • Novartis Investigative Site
      • Hokkaido, Japan, 060-8543
        • Novartis Investigative Site
      • Hokkaido, Japan, 060-8648
        • Novartis Investigative Site
      • Ibaraki, Japan, 305-8576
        • Novartis Investigative Site
      • Iwate, Japan, 020-8505
        • Novartis Investigative Site
      • Kanagawa, Japan, 236-0004
        • Novartis Investigative Site
      • Kyoto, Japan, 606-8507
        • Novartis Investigative Site
      • Okayama, Japan, 700-8558
        • Novartis Investigative Site
      • Osaka, Japan, 589-8511
        • Novartis Investigative Site
      • Osaka, Japan, 565-0871
        • Novartis Investigative Site
      • Shizuoka, Japan, 431-3192
        • Novartis Investigative Site
      • Tokyo, Japan, 104-0045
        • Novartis Investigative Site
      • Tokyo, Japan, 135-8550
        • Novartis Investigative Site
      • Tokyo, Japan, 162-8666
        • Novartis Investigative Site
      • Tokyo, Japan, 160-8582
        • Novartis Investigative Site
      • Tokyo, Japan, 113-8655
        • Novartis Investigative Site
      • Tokyo, Japan, 173-8606
        • Novartis Investigative Site
      • Yamagata, Japan, 990-9585
        • Novartis Investigative Site
  • Kina
      • Beijing, Kina, 100021
        • Novartis Investigative Site
      • Beijing, Kina, 100034
        • Novartis Investigative Site
      • Beijing, Kina, 100036
        • Novartis Investigative Site
      • Beijing, Kina, 100853
        • Novartis Investigative Site
      • Shanghai, Kina, 200032
        • Novartis Investigative Site
      • Shanghai, Kina, 200127
        • Novartis Investigative Site
      • Tianjin, Kina, 300060
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210002
        • Novartis Investigative Site
  • Korea, Republikken
      • Daegu, Korea, Republikken, 700-721
        • Novartis Investigative Site
      • Daejeon, Korea, Republikken, 301-721
        • Novartis Investigative Site
      • Goyang-si, Gyeonggi-Do, Korea, Republikken, 410-769
        • Novartis Investigative Site
      • Seoul, Korea, Republikken, 138-736
        • Novartis Investigative Site
      • Seoul, Korea, Republikken, 120-752
        • Novartis Investigative Site
      • Seoul, Korea, Republikken, 135-710
        • Novartis Investigative Site
      • Seoul, Korea, Republikken, 110-744
        • Novartis Investigative Site
  • Nederland
      • Alkmaar, Nederland, 1815 JD
        • Novartis Investigative Site
      • Amsterdam, Nederland, 1066 CX
        • Novartis Investigative Site
      • Breda, Nederland, 4819 EV
        • Novartis Investigative Site
      • Den Haag, Nederland, 2545CH
        • Novartis Investigative Site
      • Groningen, Nederland, 9713 GZ
        • Novartis Investigative Site
      • Sittard-geleen, Nederland, 6162 BG
        • Novartis Investigative Site
      • Tilburg, Nederland, 5022 GC
        • Novartis Investigative Site
      • Utrecht, Nederland, 3584 CX
        • Novartis Investigative Site
  • Spania
      • Badalona, Spania, 08916
        • Novartis Investigative Site
      • Barakaldo (Vizcaya), Spania, 48903
        • Novartis Investigative Site
      • Barcelona, Spania, 08036
        • Novartis Investigative Site
      • Gerona, Spania, 17007
        • Novartis Investigative Site
      • Madrid, Spania, 28041
        • Novartis Investigative Site
      • Madrid, Spania, 28033
        • Novartis Investigative Site
      • Madrid, Spania, 28040
        • Novartis Investigative Site
      • Pamplona, Spania, 31008
        • Novartis Investigative Site
  • Storbritannia
      • Bebington, Wirral, Storbritannia, CH63 4JY
        • Novartis Investigative Site
      • Birmingham, Storbritannia, B15 2TH
        • Novartis Investigative Site
      • Cambridge, Storbritannia, CB2 0QQ
        • Novartis Investigative Site
      • Glasgow, Storbritannia, G12 OYN
        • Novartis Investigative Site
      • Leeds, Storbritannia, LS9 7TF
        • Novartis Investigative Site
      • London, Storbritannia, SE1 9RT
        • Novartis Investigative Site
      • London, Storbritannia, SW3 6JJ
        • Novartis Investigative Site
      • London, Storbritannia, NW3 2QG
        • Novartis Investigative Site
      • London, Storbritannia, EC1A 7BE
        • Novartis Investigative Site
      • Manchester, Storbritannia, M20 4BX
        • Novartis Investigative Site
      • Nottingham, Storbritannia, NG5 1PB
        • Novartis Investigative Site
      • Sheffield, Storbritannia, S10 2SJ
        • Novartis Investigative Site
      • Swansea, Storbritannia, SA2 8QA
        • Novartis Investigative Site
    • Gloucestershire
      • Bristol, Gloucestershire, Storbritannia, BS2 8ED
        • Novartis Investigative Site
    • Middlesex
      • Northwood, Middlesex, Storbritannia, HA6 2RN
        • Novartis Investigative Site
  • Sverige
      • Lund, Sverige, SE-221 85
        • Novartis Investigative Site
      • Stockholm, Sverige, SE-171 76
        • Novartis Investigative Site
      • Uppsala, Sverige, SE-751 85
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung Hsien, Taiwan, 833
        • Novartis Investigative Site
      • Taichung, Taiwan, 40705
        • Novartis Investigative Site
      • Taichung, Taiwan, 40402
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 333
        • Novartis Investigative Site
  • Tyskland
      • Berlin, Tyskland, 10117
        • Novartis Investigative Site
      • Berlin, Tyskland, 10719
        • Novartis Investigative Site
    • Baden-Wuerttemberg
      • Kirchheim, Baden-Wuerttemberg, Tyskland, 73230
        • Novartis Investigative Site
      • Sigmaringen, Baden-Wuerttemberg, Tyskland, 72488
        • Novartis Investigative Site
      • Stuttgart, Baden-Wuerttemberg, Tyskland, 70174
        • Novartis Investigative Site
    • Bayern
      • Muenchen, Bayern, Tyskland, 81377
        • Novartis Investigative Site
      • Planegg, Bayern, Tyskland, 82152
        • Novartis Investigative Site
    • Hessen
      • Marburg, Hessen, Tyskland, 35043
        • Novartis Investigative Site
      • Offenbach, Hessen, Tyskland, 63069
        • Novartis Investigative Site
    • Niedersachsen
      • Hannover, Niedersachsen, Tyskland, 30171
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Tyskland, 52074
        • Novartis Investigative Site
      • Bonn, Nordrhein-Westfalen, Tyskland, 53127
        • Novartis Investigative Site
      • Dortmund, Nordrhein-Westfalen, Tyskland, 44145
        • Novartis Investigative Site
      • Duesseldorf, Nordrhein-Westfalen, Tyskland, 40225
        • Novartis Investigative Site
      • Duisburg, Nordrhein-Westfalen, Tyskland, 47053
        • Novartis Investigative Site
      • Essen, Nordrhein-Westfalen, Tyskland, 45122
        • Novartis Investigative Site
    • Saarland
      • Homburg, Saarland, Tyskland, 66421
        • Novartis Investigative Site
    • Sachsen
      • Dresden, Sachsen, Tyskland, 01307
        • Novartis Investigative Site
      • Leipzig, Sachsen, Tyskland, 04103
        • Novartis Investigative Site
      • Plauen, Sachsen, Tyskland, 08523
        • Novartis Investigative Site
    • Sachsen-Anhalt
      • Eisleben, Sachsen-Anhalt, Tyskland, 06295
        • Novartis Investigative Site
      • Magdeburg, Sachsen-Anhalt, Tyskland, 39104
        • Novartis Investigative Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Written informed consent
  • Diagnosis of renal cell carcinoma with clear-cell component histology.
  • Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC
  • Locally advanced or metastatic renal cell carcinoma
  • Measurable disease by CT or MRI
  • Karnofsky performance scale status of >=70
  • Age >=18 years
  • A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception.
  • Adequate organ system function
  • Total serum calcium concentration <12.0mg/dL
  • Left ventricular ejection fraction >= lower limit of institutional normal.

Exclusion Criteria:

  • Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)
  • History of another malignancy (unless have been disease-free for 3 years)
  • History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for >=6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants)
  • Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, 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.
  • Presence of uncontrolled infection.
  • Prolongation of corrected QT interval (QTc) > 480 milliseconds
  • History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association
  • History of cerebrovascular accident including transient ischemic attack within the past 12 months
  • History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless had recent DVT and have been treated with therapeutic anti-coagulating agents for at least 6 weeks)
  • Poorly controlled hypertension (defined as systolic blood pressure of >=150mmHg or diastolic blood pressure of >=90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
  • Evidence of active bleeding or bleeding susceptibility
  • Spitting/coughing up blood within 6 weeks of first dose of study drug
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
  • Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study.
  • Use any prohibited medications within 14 days of the first dose of study medication.
  • Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
  • Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (eg. temsirolimus, everolimus, etc).
  • Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy)
  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Sunitinib
Control arm
Legemiddel: Sunitinib
50 mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment
Eksperimentell: Pazopanib
Experimental arm
Legemiddel: Pazopanib
800 mg administrert én gang daglig oral kontinuerlig dosering

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free Survival (PFS)
Tidsramme: From randomization until the earliest date of disease progression or death (up to Study Week 191)
PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion. The Kaplan-Meier method was used for PFS estimates.
From randomization until the earliest date of disease progression or death (up to Study Week 191)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival
Tidsramme: From randomization until death (up to Study Week 268)
Overall survival is defined as the time from randomization until death due to any cause.
From randomization until death (up to Study Week 268)
Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review
Tidsramme: From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)
The number of participants with evidence of CR (the disappearance of all target and non-target lesions), PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria), or Progressive Disease (a >=20% increase in target lesions within the first 12 weeks of treatment) was evaluated by an independent review per RECIST, Version 1.
From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)
Time to Response
Tidsramme: From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)
Time to response is defined as the time from the start of treatment until the first documented evidence of CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.
From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)
Duration of Response (DOR)
Tidsramme: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)
DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.
From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)
Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)
Tidsramme: From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268)
See the SAE/AE module for a list of all SAEs/AEs. SAE=any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly/birth defect, or a Grade 4 laboratory abnormality. Events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment.
From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268)
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Baseline (predose); Weeks 4, 10, 16, and 22
The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life (HRQoL) experienced in the past seven days. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). A negative change from Baseline represents a worsening condition. Change from Baseline was calculated as the assessment week value minus the Baseline value.
Baseline (predose); Weeks 4, 10, 16, and 22
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Baseline; Weeks 4, 10, 16, and 22
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). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Baseline; Weeks 4, 10, 16, and 22
The FKSI-19 is a disease-specific instrument measuring 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 change from Baseline (BL) represents a worsening of condition. Change from BL was calculated as the assessment week value minus the BL value.
Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Baseline; Weeks 4, 10, 16, and 22
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).Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Baseline; Weeks 4, 10, 16, and 22
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). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Baseline; Weeks 4, 10, 16, and 22
The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (DRS-P, DRS-E, TSE, and FWB). 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). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Baseline; Weeks 4, 10, 16, and 22
The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of " In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness?" by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition.
Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Baseline; Weeks 4, 10, 16, and 22
The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Participants (par.) assessed the limitations caused by their mouth/throat soreness by answering the question of "In the past 4 weeks, how much did your worst mouth/throat soreness limit you in the following activities: swallowing/eating/drinking/talking/sleeping" by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from "3" for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition.
Baseline; Weeks 4, 10, 16, and 22
Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Baseline; Weeks 4, 10, 16, and 22
The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Par. assessed the limitations caused by their foot soreness by answering the question of "In the past 4 weeks, how much did your worst foot soreness limit you in each of the following activities: standing/walking/climbing stairs/sleeping/ability to do usual activities" by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from "3" for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition.
Baseline; Weeks 4, 10, 16, and 22
Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Weeks 4, 10, 16, and 22
The CTSQ assesses 3 domains related to the participant's satisfaction with cancer therapy: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Participants shared their thoughts on their cancer therapy (9 questions), their satisfaction with their most recently administered cancer therapy (6 questions), and if they would take the same cancer therapy if given the choice to do so again. All questions were assessed on a 5-point scale; 1, never; 5, always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health.
Weeks 4, 10, 16, and 22
Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24
Tidsramme: From Day 1 up to Week 24
Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician's assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.
From Day 1 up to Week 24
MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Tidsramme: Weeks 4, 10, 16, and 22
The number of non-study laboratory visits (NSLVs), non-study radiology visits (NSRVs), and home healthcare visits (HHVs) were each collected as a single question on the eCRF. The number of non-study medical or surgical procedures (MSPs) was defined as the sum of procedures performed at outpatient or physician clinics, as well as those performed during any inpatient hospitalization.
Weeks 4, 10, 16, and 22

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. august 2008

Primær fullføring (Faktiske)

21. mai 2012

Studiet fullført (Faktiske)

24. mars 2021

Datoer for studieregistrering

Først innsendt

22. juli 2008

Først innsendt som oppfylte QC-kriteriene

22. juli 2008

Først lagt ut (Anslag)

23. juli 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mai 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 108844
  • 2008-002102-19 (EudraCT-nummer)
  • CPZP034A2301 (Annen identifikator: Novartis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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