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

28 ottobre 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

512

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Pfizer Investigational Site
      • St Leonards, New South Wales, Australia, 2065
        • Pfizer Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • Pfizer Investigational Site
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
      • Elizabeth Vale, South Australia, Australia, 5112
        • Pfizer Investigational Site
      • Woodville South, South Australia, Australia, 5011
        • Pfizer Investigational Site
  • Austria
      • Salzburg, Austria, 5020
        • Pfizer Investigational Site
      • Wien, Austria, 1090
        • 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
  • Cina
      • Hong Kong, Cina
        • Pfizer Investigational Site
  • Corea, Repubblica di
      • Seoul, Corea, Repubblica di, 120-752
        • Pfizer Investigational Site
      • Seoul, Corea, Repubblica di, 138-736
        • Pfizer Investigational Site
      • Seoul, Corea, Repubblica di, 110-744
        • Pfizer Investigational Site
      • Seoul, Corea, Repubblica di, 135-710
        • Pfizer Investigational Site
  • Danimarca
      • Aarhus C, Danimarca, 8000
        • Pfizer Investigational Site
      • Herlev, Danimarca, 2730
        • Pfizer Investigational Site
  • Finlandia
      • Tampere, Finlandia, 33 521
        • Pfizer Investigational Site
      • Turku, Finlandia, 20 520
        • Pfizer Investigational Site
  • Francia
      • Angers, Francia, 49100
        • Pfizer Investigational Site
      • Besancon, Francia, 25000
        • Pfizer Investigational Site
      • Bordeaux, Francia, 33075
        • Pfizer Investigational Site
      • Caen Cedex 05, Francia, 14076
        • Pfizer Investigational Site
      • Clermont-Ferrand Cedex 1, Francia, 63011
        • Pfizer Investigational Site
      • Dijon, Francia, 21079
        • Pfizer Investigational Site
      • Lille, Francia, 59000
        • Pfizer Investigational Site
      • Lyon Cedex 08, Francia, 69373
        • Pfizer Investigational Site
      • Marseille Cedex 9, Francia, 13273
        • Pfizer Investigational Site
      • Paris Cedex 15, Francia, 75908
        • Pfizer Investigational Site
      • Poitiers Cedex, Francia, 86021
        • Pfizer Investigational Site
      • Saint Herlain/Nantes Cedex, Francia, 44805
        • Pfizer Investigational Site
      • Strasbourg, Francia, 67091
        • Pfizer Investigational Site
      • Vandoeuvre Les Nancy, Francia, 54511
        • Pfizer Investigational Site
      • Villejuif Cedex, Francia, 94805
        • Pfizer Investigational Site
    • Cedex 5
      • Montpellier, Cedex 5, Francia, 34298
        • Pfizer Investigational Site
  • Germania
      • Berlin, Germania, 10117
        • Pfizer Investigational Site
      • Dresden, Germania, 01307
        • Pfizer Investigational Site
      • Heidelberg, Germania, 69120
        • Pfizer Investigational Site
      • Kassel, Germania, 34125
        • Pfizer Investigational Site
      • Luebeck, Germania, 23538
        • Pfizer Investigational Site
      • Muenchen, Germania, 81675
        • Pfizer Investigational Site
      • Neuss, Germania, 41464
        • Pfizer Investigational Site
      • Ulm, Germania, 89081
        • Pfizer Investigational Site
  • Italia
      • Chieti, Italia, 66013
        • Pfizer Investigational Site
      • Firenze, Italia, 50134
        • Pfizer Investigational Site
      • Napoli, Italia, 80131
        • Pfizer Investigational Site
      • Pavia, Italia, 27100
        • Pfizer Investigational Site
      • Roma, Italia, 00144
        • Pfizer Investigational Site
      • Roma, Italia, 00152
        • Pfizer Investigational Site
      • Roma, Italia, 0144
        • Pfizer Investigational Site
  • Olanda
      • Dordrecht, Olanda, 3318 AT
        • Pfizer Investigational Site
      • Leeuwarden, Olanda, 8934 AD
        • Pfizer Investigational Site
      • Zwolle, Olanda, 8025 AB
        • Pfizer Investigational Site
  • Regno Unito
      • Birmingham, Regno Unito, B15 2TH
        • Pfizer Investigational Site
      • London, Regno Unito, SE1 9RT
        • Pfizer Investigational Site
      • Manchester, Regno Unito, M23 9LT
        • Pfizer Investigational Site
      • Newcastle upon Tyne, Regno Unito, NE4 6BE
        • Pfizer Investigational Site
    • Birmingham
      • Edgbaston, Birmingham, Regno Unito, B5 7UG
        • Pfizer Investigational Site
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Regno Unito, CB2 0QQ
        • Pfizer Investigational Site
    • Manchester
      • Withington, Manchester, Regno Unito, M20 4BX
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 169610
        • Pfizer Investigational Site
  • Spagna
      • Barcelona, Spagna, 08025
        • Pfizer Investigational Site
      • Madrid, Spagna, 28007
        • Pfizer Investigational Site
      • Madrid, Spagna, 28041
        • Pfizer Investigational Site
      • Sevilla, Spagna, 41013
        • Pfizer Investigational Site
      • Valencia, Spagna, 46010
        • Pfizer Investigational Site
    • Asturias
      • Oviedo, Asturias, Spagna, 33006
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spagna, 08916
        • Pfizer Investigational Site
      • Sabadell, Barcelona, Spagna, 08208
        • Pfizer Investigational Site
  • Stati Uniti
    • California
      • Duarte, California, Stati Uniti, 91010
        • Pfizer Investigational Site
      • La Jolla, California, Stati Uniti, 92037
        • Pfizer Investigational Site
      • La Jolla, California, Stati Uniti, 92093
        • Pfizer Investigational Site
      • Los Angeles, California, Stati Uniti, 90095
        • Pfizer Investigational Site
      • Los Angeles, California, Stati Uniti, 90095-6984
        • Pfizer Investigational Site
      • Orange, California, Stati Uniti, 92868
        • Pfizer Investigational Site
      • Riverside, California, Stati Uniti, 92505
        • Pfizer Investigational Site
      • San Diego, California, Stati Uniti, 92103
        • Pfizer Investigational Site
    • Connecticut
      • Meriden, Connecticut, Stati Uniti, 06451
        • Pfizer Investigational Site
    • Indiana
      • Municie, Indiana, Stati Uniti, 47303
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40202
        • Pfizer Investigational Site
    • Louisiana
      • Metairie, Louisiana, Stati Uniti, 70006
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Pfizer Investigational Site
      • Bethesda, Maryland, Stati Uniti, 20817
        • Pfizer Investigational Site
    • Mississippi
      • Tupelo, Mississippi, Stati Uniti, 38801
        • Pfizer Investigational Site
    • New York
      • New York, New York, Stati Uniti, 10065
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73120
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, Stati Uniti, 74104
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Stati Uniti, 78731
        • Pfizer Investigational Site
      • Dallas, Texas, Stati Uniti, 75246
        • Pfizer Investigational Site
      • Dallas, Texas, Stati Uniti, 75226
        • Pfizer Investigational Site
      • San Antonio, Texas, Stati Uniti, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84112-5550
        • Pfizer Investigational Site
      • Salt Lake City, Utah, Stati Uniti, 84412
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Stati Uniti, 98101
        • Pfizer Investigational Site
  • Svezia
      • Göteborg, Svezia, SE-413 45
        • Pfizer Investigational Site
      • Lund, Svezia, 221 85
        • Pfizer Investigational Site
      • Malmo, Svezia, 205 02
        • Pfizer Investigational Site
  • Svizzera
      • Basel, Svizzera
        • Pfizer Investigational Site
      • Bruderholz, Svizzera
        • Pfizer Investigational Site
      • Luzern, Svizzera, 6000
        • Pfizer Investigational Site
      • Rheinstrasse 26, Svizzera
        • Pfizer Investigational Site
    • BS
      • Basel, BS, Svizzera, 4031
        • Pfizer Investigational Site
    • Basel
      • Kleinriehenstrasse 30, Basel, Svizzera
        • Pfizer Investigational Site
    • GE
      • Geneva, GE, Svizzera, 1221
        • Pfizer Investigational Site
  • Ungheria
      • Budapest, Ungheria, H-1122
        • Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 1
Droga: Sorafenib
Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).
Sperimentale: 2
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-Free Survival (PFS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival (PFS) by Investigator Assessment
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2007

Completamento primario (Effettivo)

1 gennaio 2012

Completamento dello studio (Effettivo)

1 gennaio 2013

Date di iscrizione allo studio

Primo inviato

15 maggio 2007

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2007

Primo Inserito (Stima)

17 maggio 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

21 novembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2013

Ultimo verificato

1 ottobre 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 3066K1-404
  • B1771003

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Carcinoma a cellule renali

Prove cliniche su Sorafenib

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Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in South Africa

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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