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A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

15. juni 2012 oppdatert av: Pfizer

Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated

To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.

Studietype

Intervensjonell

Registrering (Faktiske)

482

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1405BCH
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1034ACO
        • Pfizer Investigational Site
      • Cordoba, Argentina, X5000AAI
        • Pfizer Investigational Site
      • Tucuman, Argentina, T4000IAK
        • Pfizer Investigational Site
    • Prov. de Buenos Aires
      • Bahia Blanca, Prov. de Buenos Aires, Argentina, B8001HXM
        • Pfizer Investigational Site
    • Rio Negro
      • Viedma, Rio Negro, Argentina, 8500
        • Pfizer Investigational Site
    • Santa Fé
      • Rosario, Santa Fé, Argentina, (2000)
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Pfizer Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Pfizer Investigational Site
      • Parkville, Victoria, Australia, 3050
        • Pfizer Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Pfizer Investigational Site
  • Brasil
    • PR
      • Curitiba, PR, Brasil, 80530-010
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brasil, 20560-120
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brasil, 90610-000
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brasil, 91350-200
        • Pfizer Investigational Site
    • SP
      • São Paulo, SP, Brasil, 01509-900
        • Pfizer Investigational Site
      • São Paulo, SP, Brasil, 01246-000
        • Pfizer Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1233
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1527
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1756
        • Pfizer Investigational Site
      • Stara Zagora, Bulgaria, 6000
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1S 4L8
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Pfizer Investigational Site
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Pfizer Investigational Site
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Pfizer Investigational Site
  • Chile
    • IX Región
      • Temuco, IX Región, Chile, 4810469
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • Filippinene
      • Quezon City, Filippinene, 1100
        • Pfizer Investigational Site
      • Quezon City, Filippinene, 1102
        • Pfizer Investigational Site
      • Quezon City, Filippinene, 1104
        • Pfizer Investigational Site
      • San Juan City, Filippinene, 1000
        • Pfizer Investigational Site
  • Frankrike
      • Bayonne, Frankrike, 64100
        • Pfizer Investigational Site
      • Besancon, Frankrike, 25030
        • Pfizer Investigational Site
      • Clermont Ferrand, Frankrike, 63011
        • Pfizer Investigational Site
      • Lille, Frankrike, 59020 Cedex
        • Pfizer Investigational Site
      • Neuilly Sur Seine, Frankrike, 92200
        • Pfizer Investigational Site
      • Nice, Frankrike, 06100
        • Pfizer Investigational Site
      • Rennes Cedex, Frankrike, 35042
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Pfizer Investigational Site
      • Kowloon, Hong Kong
        • Pfizer Investigational Site
      • Tuen Mun, Hong Kong
        • Pfizer Investigational Site
      • Wan Chai,, Hong Kong
        • Pfizer Investigational Site
  • India
    • Gujarat
      • Navrangpura / Ahmedabad, Gujarat, India, 380 009
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 078
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141 008
        • Pfizer Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302013
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Pfizer Investigational Site
  • Italia
      • Firenze, Italia, 50134
        • Pfizer Investigational Site
      • Milano, Italia, 20162
        • Pfizer Investigational Site
      • Napoli, Italia, 80131
        • Pfizer Investigational Site
      • Reggio Emilia, Italia, 42100
        • Pfizer Investigational Site
  • Japan
      • Fukuoka, Japan
        • Pfizer Investigational Site
      • Osaka, Japan
        • Pfizer Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Pfizer Investigational Site
    • Ehime
      • Matsuyama-shi, Ehime, Japan
        • Pfizer Investigational Site
    • Fukuoka
      • Kitakyushu-City, Fukuoka, Japan
        • Pfizer Investigational Site
    • Osaka
      • Suita, Osaka, Japan
        • Pfizer Investigational Site
    • Saitama
      • Kita-adachi-gun, Saitama, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Chuo-Ku, Tokyo, Japan
        • Pfizer Investigational Site
  • Korea, Republikken
      • Daegu, Korea, Republikken, 705-717
        • Pfizer Investigational Site
      • Incheon, Korea, Republikken, 400-711
        • Pfizer Investigational Site
      • Pusan, Korea, Republikken, 602-739
        • Pfizer Investigational Site
      • Seoul, Korea, Republikken, 110-744
        • Pfizer Investigational Site
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republikken, 410-769
        • Pfizer Investigational Site
  • Mexico
      • Chihuahua, Mexico, 31000
        • Pfizer Investigational Site
      • Puebla, Mexico, 72530
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 11000
        • Pfizer Investigational Site
    • Estado de Mexico
      • Toluca, Estado de Mexico, Mexico, 50180
        • Pfizer Investigational Site
    • Guerrero
      • Acapulco, Guerrero, Mexico, 39670
        • Pfizer Investigational Site
    • Michoacan
      • Morelia, Michoacan, Mexico, 58020
        • Pfizer Investigational Site
    • Sonora
      • Ciudad Obregon, Sonora, Mexico, 85000
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, 05127
        • Pfizer Investigational Site
      • Lima, Peru, L 27
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Pfizer Investigational Site
      • Singapore, Singapore, 169610
        • Pfizer Investigational Site
  • Spania
      • Cordoba, Spania, 14004
        • Pfizer Investigational Site
      • Gerona, Spania, 17007
        • Pfizer Investigational Site
      • Jaen, Spania, 23007
        • Pfizer Investigational Site
      • La Coruña, Spania, 15006
        • Pfizer Investigational Site
      • Las Palmas de Gran Canaria, Spania, 35016
        • Pfizer Investigational Site
      • Madrid, Spania, 28040
        • Pfizer Investigational Site
      • Madrid, Spania, 28033
        • Pfizer Investigational Site
      • Malaga, Spania, 29010
        • Pfizer Investigational Site
      • Salamanca, Spania, 37007
        • Pfizer Investigational Site
    • Barcelona
      • Mataro, Barcelona, Spania, 08304
        • Pfizer Investigational Site
      • Sabadell, Barcelona, Spania, 08208
        • Pfizer Investigational Site
    • Cantabria
      • Santander, Cantabria, Spania, 39008
        • Pfizer Investigational Site
    • Madrid
      • Alcorcon, Madrid, Spania, 28922
        • Pfizer Investigational Site
    • Vizcaya
      • Bilbao, Vizcaya, Spania, 48013
        • Pfizer Investigational Site
  • Storbritannia
      • London, Storbritannia, SE1 9RT
        • Pfizer Investigational Site
      • Nottingham, Storbritannia, NG5 1PB
        • Pfizer Investigational Site
      • Somerset, Storbritannia, BA21 4AT
        • Pfizer Investigational Site
    • South Wales
      • Cardiff, South Wales, Storbritannia, CF14 2TL
        • Pfizer Investigational Site
  • Sør-Afrika
      • Parktown, Sør-Afrika, 2193
        • Pfizer Investigational Site
      • Sandton, Sør-Afrika, 2199
        • Pfizer Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Pfizer Investigational Site
      • Kaohsiung, Taiwan, 807
        • Pfizer Investigational Site
      • Tainan, Taiwan, 704
        • Pfizer Investigational Site
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
      • Taipei, Taiwan, 106
        • Pfizer Investigational Site
      • Taoyuan, Taiwan, 333
        • Pfizer Investigational Site
  • Tyrkia
      • Ankara, Tyrkia, 06100
        • Pfizer Investigational Site
      • Istanbul, Tyrkia, 34390
        • Pfizer Investigational Site
  • Tyskland
      • Berlin, Tyskland, 12200
        • Pfizer Investigational Site
      • Frankfurt, Tyskland, 60488
        • Pfizer Investigational Site
      • Freiburg, Tyskland, 79106
        • Pfizer Investigational Site
      • Jena, Tyskland, 07743
        • Pfizer Investigational Site
      • Kiel, Tyskland, 24103
        • Pfizer Investigational Site
      • Leer, Tyskland, 26789
        • Pfizer Investigational Site
      • Luebeck, Tyskland, 23538
        • Pfizer Investigational Site
      • Magdeburg, Tyskland, 39130
        • Pfizer Investigational Site
      • Mainz, Tyskland, 55101
        • Pfizer Investigational Site
      • Meiningen, Tyskland, 98617
        • Pfizer Investigational Site
      • Muenchen, Tyskland, 81675
        • Pfizer Investigational Site
      • Offenburg, Tyskland, 77652
        • Pfizer Investigational Site
      • Tuebingen, Tyskland, 72076
        • Pfizer Investigational 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

Hunn

Beskrivelse

Inclusion Criteria:

  • breast adenocarcinoma
  • prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Exclusion Criteria:

  • Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
  • Any prior regimen with capecitabine

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: A
1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Legemiddel: Capecitabine
1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Andre navn:
  • xeloda
Eksperimentell: B
37.5 mg daily, continuous dosing
Legemiddel: Sunitinib malate
37.5 mg daily, continuous dosing
Andre navn:
  • sunitinib

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: From time of randomization to every 6 weeks thereafter through 22 months or until death
Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.
From time of randomization to every 6 weeks thereafter through 22 months or until death

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Tumor Progression (TTP)
Tidsramme: From time of randomization to every 6 weeks thereafter through 22 months
Time from randomization to first documentation of objective tumor progression.
From time of randomization to every 6 weeks thereafter through 22 months
Number of Participants With Overall Response (OR)
Tidsramme: From time of randomization to every 6 weeks thereafter through 22 months
OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
From time of randomization to every 6 weeks thereafter through 22 months
Duration of Response (DR)
Tidsramme: From time of randomization to every 6 weeks thereafter through 22 months or death
Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
From time of randomization to every 6 weeks thereafter through 22 months or death
Time to Tumor Response (TTR)
Tidsramme: From time of randomization to every 6 weeks thereafter through 22 months
Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
From time of randomization to every 6 weeks thereafter through 22 months
Overall Survival (OS)
Tidsramme: From time of randomization until death
Average time from randomization to first documentation of death due to any cause.
From time of randomization until death
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Tidsramme: From Day 1 of Cycle 1, then odd numbered cycles thereafter

EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).

Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.
From Day 1 of Cycle 1, then odd numbered cycles thereafter
EORTC QLQ Breast Cancer Module (BR23)
Tidsramme: From Day 1 of Cycle 1, then odd numbered cycles thereafter

BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much.

Scale score range: 0 to 100. Higher symptom score implied a greater degree of symptoms.
From Day 1 of Cycle 1, then odd numbered cycles thereafter

Samarbeidspartnere og etterforskere

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

Sponsor

Pfizer

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.

Hjelpsomme linker

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

1. november 2006

Primær fullføring (Faktiske)

1. oktober 2009

Studiet fullført (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først innsendt

5. september 2006

Først innsendt som oppfylte QC-kriteriene

5. september 2006

Først lagt ut (Anslag)

7. september 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. juni 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2012

Sist bekreftet

1. juni 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A6181107

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. .

Kliniske studier på Brystneoplasmer

Kliniske studier på Capecitabine

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Colombia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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