Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib (INTORSECT)

28. oktober 2013 opdateret af: Pfizer

A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy

This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

512

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1437JCP
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1426ANZ
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1122AAL
        • Pfizer Investigational Site
      • Nueva Cordoba, Argentina, X5006HBF
        • Pfizer Investigational Site
      • Tucuman, Argentina, T4000 IAK
        • Pfizer Investigational Site
    • Santa Fé
      • Rosario, Santa Fé, Argentina, S2000KZE
        • Pfizer Investigational Site
  • Australien
    • New South Wales
      • Kogarah, New South Wales, Australien, 2217
        • Pfizer Investigational Site
      • St Leonards, New South Wales, Australien, 2065
        • Pfizer Investigational Site
      • Westmead, New South Wales, Australien, 2145
        • Pfizer Investigational Site
    • Queensland
      • South Brisbane, Queensland, Australien, 4101
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Pfizer Investigational Site
      • Elizabeth Vale, South Australia, Australien, 5112
        • Pfizer Investigational Site
      • Woodville South, South Australia, Australien, 5011
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Pfizer Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Pfizer Investigational Site
      • Victoria, British Columbia, Canada, V8R 6V5
        • 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
      • Cornwall, Ontario, Canada, K6R 5S5
        • Pfizer Investigational Site
      • Hamilton, Ontario, Canada, L8N 4A6
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 4G5
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 4L6
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4K7
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Pfizer Investigational Site
  • Chile
    • Santiago
      • Providencia, Santiago, Chile
        • Pfizer Investigational Site
  • Danmark
      • Aarhus C, Danmark, 8000
        • Pfizer Investigational Site
      • Herlev, Danmark, 2730
        • Pfizer Investigational Site
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B15 2TH
        • Pfizer Investigational Site
      • London, Det Forenede Kongerige, SE1 9RT
        • Pfizer Investigational Site
      • Manchester, Det Forenede Kongerige, M23 9LT
        • Pfizer Investigational Site
      • Newcastle upon Tyne, Det Forenede Kongerige, NE4 6BE
        • Pfizer Investigational Site
    • Birmingham
      • Edgbaston, Birmingham, Det Forenede Kongerige, B5 7UG
        • Pfizer Investigational Site
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
        • Pfizer Investigational Site
    • Manchester
      • Withington, Manchester, Det Forenede Kongerige, M20 4BX
        • Pfizer Investigational Site
  • Finland
      • Tampere, Finland, 33 521
        • Pfizer Investigational Site
      • Turku, Finland, 20 520
        • Pfizer Investigational Site
  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010
        • Pfizer Investigational Site
      • La Jolla, California, Forenede Stater, 92037
        • Pfizer Investigational Site
      • La Jolla, California, Forenede Stater, 92093
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90095
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90095-6984
        • Pfizer Investigational Site
      • Orange, California, Forenede Stater, 92868
        • Pfizer Investigational Site
      • Riverside, California, Forenede Stater, 92505
        • Pfizer Investigational Site
      • San Diego, California, Forenede Stater, 92103
        • Pfizer Investigational Site
    • Connecticut
      • Meriden, Connecticut, Forenede Stater, 06451
        • Pfizer Investigational Site
    • Indiana
      • Municie, Indiana, Forenede Stater, 47303
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Pfizer Investigational Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Pfizer Investigational Site
      • Bethesda, Maryland, Forenede Stater, 20817
        • Pfizer Investigational Site
    • Mississippi
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Pfizer Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10065
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78731
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75246
        • Pfizer Investigational Site
      • Dallas, Texas, Forenede Stater, 75226
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112-5550
        • Pfizer Investigational Site
      • Salt Lake City, Utah, Forenede Stater, 84412
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • Pfizer Investigational Site
  • Frankrig
      • Angers, Frankrig, 49100
        • Pfizer Investigational Site
      • Besancon, Frankrig, 25000
        • Pfizer Investigational Site
      • Bordeaux, Frankrig, 33075
        • Pfizer Investigational Site
      • Caen Cedex 05, Frankrig, 14076
        • Pfizer Investigational Site
      • Clermont-Ferrand Cedex 1, Frankrig, 63011
        • Pfizer Investigational Site
      • Dijon, Frankrig, 21079
        • Pfizer Investigational Site
      • Lille, Frankrig, 59000
        • Pfizer Investigational Site
      • Lyon Cedex 08, Frankrig, 69373
        • Pfizer Investigational Site
      • Marseille Cedex 9, Frankrig, 13273
        • Pfizer Investigational Site
      • Paris Cedex 15, Frankrig, 75908
        • Pfizer Investigational Site
      • Poitiers Cedex, Frankrig, 86021
        • Pfizer Investigational Site
      • Saint Herlain/Nantes Cedex, Frankrig, 44805
        • Pfizer Investigational Site
      • Strasbourg, Frankrig, 67091
        • Pfizer Investigational Site
      • Vandoeuvre Les Nancy, Frankrig, 54511
        • Pfizer Investigational Site
      • Villejuif Cedex, Frankrig, 94805
        • Pfizer Investigational Site
    • Cedex 5
      • Montpellier, Cedex 5, Frankrig, 34298
        • Pfizer Investigational Site
  • Holland
      • Dordrecht, Holland, 3318 AT
        • Pfizer Investigational Site
      • Leeuwarden, Holland, 8934 AD
        • Pfizer Investigational Site
      • Zwolle, Holland, 8025 AB
        • Pfizer Investigational Site
  • Italien
      • Chieti, Italien, 66013
        • Pfizer Investigational Site
      • Firenze, Italien, 50134
        • Pfizer Investigational Site
      • Napoli, Italien, 80131
        • Pfizer Investigational Site
      • Pavia, Italien, 27100
        • Pfizer Investigational Site
      • Roma, Italien, 00144
        • Pfizer Investigational Site
      • Roma, Italien, 00152
        • Pfizer Investigational Site
      • Roma, Italien, 0144
        • Pfizer Investigational Site
  • Kina
      • Hong Kong, Kina
        • Pfizer Investigational Site
  • Korea, Republikken
      • Seoul, Korea, Republikken, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republikken, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republikken, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republikken, 135-710
        • Pfizer Investigational Site
  • Schweiz
      • Basel, Schweiz
        • Pfizer Investigational Site
      • Bruderholz, Schweiz
        • Pfizer Investigational Site
      • Luzern, Schweiz, 6000
        • Pfizer Investigational Site
      • Rheinstrasse 26, Schweiz
        • Pfizer Investigational Site
    • BS
      • Basel, BS, Schweiz, 4031
        • Pfizer Investigational Site
    • Basel
      • Kleinriehenstrasse 30, Basel, Schweiz
        • Pfizer Investigational Site
    • GE
      • Geneva, GE, Schweiz, 1221
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 169610
        • Pfizer Investigational Site
  • Spanien
      • Barcelona, Spanien, 08025
        • Pfizer Investigational Site
      • Madrid, Spanien, 28007
        • Pfizer Investigational Site
      • Madrid, Spanien, 28041
        • Pfizer Investigational Site
      • Sevilla, Spanien, 41013
        • Pfizer Investigational Site
      • Valencia, Spanien, 46010
        • Pfizer Investigational Site
    • Asturias
      • Oviedo, Asturias, Spanien, 33006
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spanien, 08916
        • Pfizer Investigational Site
      • Sabadell, Barcelona, Spanien, 08208
        • Pfizer Investigational Site
  • Sverige
      • Göteborg, Sverige, SE-413 45
        • Pfizer Investigational Site
      • Lund, Sverige, 221 85
        • Pfizer Investigational Site
      • Malmo, Sverige, 205 02
        • Pfizer Investigational Site
  • Tyskland
      • Berlin, Tyskland, 10117
        • Pfizer Investigational Site
      • Dresden, Tyskland, 01307
        • Pfizer Investigational Site
      • Heidelberg, Tyskland, 69120
        • Pfizer Investigational Site
      • Kassel, Tyskland, 34125
        • Pfizer Investigational Site
      • Luebeck, Tyskland, 23538
        • Pfizer Investigational Site
      • Muenchen, Tyskland, 81675
        • Pfizer Investigational Site
      • Neuss, Tyskland, 41464
        • Pfizer Investigational Site
      • Ulm, Tyskland, 89081
        • Pfizer Investigational Site
  • Ungarn
      • Budapest, Ungarn, H-1122
        • Pfizer Investigational Site
  • Østrig
      • Salzburg, Østrig, 5020
        • Pfizer Investigational Site
      • Wien, Østrig, 1090
        • 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:

  • Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
  • At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.

  • At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions.

    • More criteria apply

Exclusion Criteria:

  • Metastatic CNS from RCC.
  • Subjects who discontinued Sutent therapy due specifically to intolerance.
  • Prior systemic therapy for mRCC other than sunitinib.

  • Active ketonuria, secondary to poorly controlled diabetes mellitus

    • More criteria apply

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: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Medicin: Sorafenib
Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).
Eksperimentel: 2
Medicin: temsirolimus (Torisel)
Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: Baseline up to 24 Months
Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.
Baseline up to 24 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival (PFS) by Investigator Assessment
Tidsramme: Baseline up to 24 Months
Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.
Baseline up to 24 Months
Percentage of Participants With Tumor Response
Tidsramme: Baseline up to 24 Months
Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Baseline up to 24 Months
Overall Survival (OS)
Tidsramme: Baseline to date of death from any cause (up to 24 months)
Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Baseline to date of death from any cause (up to 24 months)
Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment
Tidsramme: Weeks 12, 24, and 36
PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.
Weeks 12, 24, and 36
Duration of Response (DR)
Tidsramme: Baseline up to 24 Months
Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.
Baseline up to 24 Months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline up to 24 months
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Baseline up to 24 months

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.

Generelle publikationer

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. september 2007

Primær færdiggørelse (Faktiske)

1. januar 2012

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

15. maj 2007

Først indsendt, der opfyldte QC-kriterier

15. maj 2007

Først opslået (Skøn)

17. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3066K1-404
  • B1771003

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