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A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.

2. april 2013 opdateret af: Pfizer
This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

123

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Pfizer Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3G 1L5
        • Pfizer Investigational Site
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, SW3 6JJ
        • Pfizer Investigational Site
      • Manchester, Det Forenede Kongerige, M20 4BX
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
        • Pfizer Investigational Site
  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Pfizer Investigational Site
      • Littleton, Colorado, Forenede Stater, 80120
        • Pfizer Investigational Site
    • Florida
      • Orlando, Florida, Forenede Stater, 32806
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Pfizer Investigational Site
    • Illinois
      • Harvey, Illinois, Forenede Stater, 60426-4265
        • Pfizer Investigational Site
      • Harvey, Illinois, Forenede Stater, 60426
        • Pfizer Investigational Site
      • Maywood, Illinois, Forenede Stater, 60153
        • Pfizer Investigational Site
      • Tinley Park, Illinois, Forenede Stater, 60477
        • Pfizer Investigational Site
      • Zion, Illinois, Forenede Stater, 60099
        • Pfizer Investigational Site
    • Indiana
      • Munster, Indiana, Forenede Stater, 46321
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Pfizer Investigational Site
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Pfizer Investigational Site
    • Missouri
      • Creve Coeur, Missouri, Forenede Stater, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63110
        • Pfizer Investigational Site
      • St. Peters, Missouri, Forenede Stater, 63376
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89135
        • Pfizer Investigational Site
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7600
        • Pfizer Investigational Site
      • Clinton, North Carolina, Forenede Stater, 28328
        • Pfizer Investigational Site
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Pfizer Investigational Site
      • Hickory, North Carolina, Forenede Stater, 28602
        • Pfizer Investigational Site
      • Wilson, North Carolina, Forenede Stater, 27893
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, Forenede Stater, 74133
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Pfizer Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • Pfizer Investigational Site
      • Greer, South Carolina, Forenede Stater, 29650
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, Forenede Stater, 29307
        • Pfizer Investigational Site
    • Texas
      • Bedford, Texas, Forenede Stater, 76022
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75246
        • Pfizer Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76177
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78207
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78258
        • Pfizer Investigational Site
  • Frankrig
      • Lyon Cedex 08, Frankrig, 69373
        • Pfizer Investigational Site
      • Marseille Cedex 20, Frankrig, 13915
        • Pfizer Investigational Site
      • Villejuif, Frankrig, 94805
        • Pfizer Investigational Site
  • Italien
      • Bologna, Italien, 40138
        • Pfizer Investigational Site
      • Cremona, Italien, 26100
        • Pfizer Investigational Site
      • Genova, Italien, 16132
        • Pfizer Investigational Site
      • Milano, Italien, 20133
        • Pfizer Investigational Site
      • Orbassano (TO), Italien, 10043
        • Pfizer Investigational Site
      • Rozzano (MI), Italien, 20089
        • Pfizer Investigational Site
  • Spanien
      • Barcelona, Spanien, 08003
        • Pfizer Investigational Site
      • Cordoba, Spanien, 14004
        • Pfizer Investigational Site
    • Alicante
      • Elche, Alicante, Spanien, 03203
        • Pfizer Investigational Site
  • Tyskland
      • Berlin, Tyskland, 10117
        • Pfizer Investigational Site
      • Grosshansdorf, Tyskland, 22927
        • Pfizer Investigational Site
      • Hamburg, Tyskland, 20246
        • Pfizer Investigational Site
      • Wiesbaden, Tyskland, 65199
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.

Exclusion Criteria:

  • Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Medicin: SU011248
Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol
Andre navne:
  • Sutent/Sunitinib

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline up to Day 28 after last dose of study treatment
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Baseline up to Day 28 after last dose of study treatment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Baseline, every 2 months until death or up to 2 years after the last dose of study treatment
Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Baseline, every 2 months until death or up to 2 years after the last dose of study treatment
Progression-Free Survival (PFS)
Tidsramme: Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication
Time to Tumor Progression (TTP)
Tidsramme: Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2006

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

2. marts 2007

Først indsendt, der opfyldte QC-kriterier

5. marts 2007

Først opslået (Skøn)

6. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. maj 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. april 2013

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A6181078

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner