Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

8 gennaio 2014 aggiornato da: Bayer

A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Overall Survival (OS), Patient-reported outcome (PRO)

Tipo di studio

Interventistico

Iscrizione (Effettivo)

903

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
      • Capital Federal-Buenos Aires, Argentina, C1426ANZ
      • Mendoza, Argentina, 5500
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSK
      • Santa Fé, Santa Fe, Argentina, S3000FFV
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Liverpool, New South Wales, Australia, 2170
      • Westmead, New South Wales, Australia, 2145
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
      • Wodonga, Victoria, Australia, 0390
  • Belgio
      • Bruxelles - Brussel, Belgio, 1000
      • Bruxelles - Brussel, Belgio, 1090
  • Brasile
    • Parana
      • Curitiba, Parana, Brasile, 81520-060
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasile, 90619900
      • Porto Alegre, Rio Grande do Sul, Brasile, 90020-060
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
      • London, Ontario, Canada, N6A 4L6
      • Toronto, Ontario, Canada, M5G 2M9
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
  • Chile
      • Santiago de Chile, Chile
  • Federazione Russa
      • Barnaul, Federazione Russa, 656049
      • Kazan, Federazione Russa, 420029
      • Kirov, Federazione Russa, 610021
      • Moscow, Federazione Russa, 125284
      • Moscow, Federazione Russa, 115478
      • Obninsk, Federazione Russa, 249036
      • St. Petersburg, Federazione Russa, 198255
  • Francia
      • Bordeaux, Francia, 33000
      • Caen Cedex 5, Francia, 14076
      • Lille Cedex, Francia, 59020
      • Lyon Cedex, Francia, 69008
      • Marseille, Francia, 13273
      • Nantes, Francia, 44805
      • Paris Cedex 15, Francia, 75908
      • Strasbourg, Francia, 67091
      • Toulouse, Francia, 31052
      • Villejuif, Francia, 94805
  • Germania
      • Berlin, Germania, 10967
      • Hamburg, Germania, 20246
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germania, 68167
      • Ulm, Baden-Württemberg, Germania, 89075
    • Bayern
      • München, Bayern, Germania, 81377
      • Regensburg, Bayern, Germania, 93042
    • Hessen
      • Darmstadt, Hessen, Germania, 64276
      • Frankfurt, Hessen, Germania, 60488
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germania, 40225
    • Sachsen
      • Dresden, Sachsen, Germania, 01307
  • Israele
      • Haifa, Israele, 3109601
      • Tel Aviv, Israele, 64239
  • Italia
      • Milano, Italia, 20133
      • Modena, Italia, 41124
      • Pavia, Italia, 27100
      • Perugia, Italia, 06122
      • Reggio Emilia, Italia, 42100
      • Roma, Italia, 00144
  • Olanda
      • Nijmegen, Olanda, 6525 GA
  • Polonia
      • Gdansk, Polonia, 80-210
      • Krakow, Polonia, 31-115
      • Lodz, Polonia, 93-509
      • Lublin, Polonia, 20-090
      • Poznan, Polonia, 61-878
      • Szczecin, Polonia, 70-111
      • Warszawa, Polonia, 02-781
      • Warszawa, Polonia, 04-141
      • Wroclaw, Polonia, 50-043
  • Regno Unito
      • Manchester, Regno Unito, M20 4BX
    • Middlesex
      • Northwood, Middlesex, Regno Unito, HA6 2RN
    • South Glamorgan
      • Cardiff, South Glamorgan, Regno Unito, CF14 2TL
    • Stratchclyde
      • Glasgow, Stratchclyde, Regno Unito, G11 6NT
    • Surrey
      • Sutton, Surrey, Regno Unito, SM2 5PT
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, Regno Unito, NE4 6BE
    • West Midlands
      • Birmingham, West Midlands, Regno Unito, B15 2TT
  • Spagna
      • Barcelona, Spagna, 08035
      • Madrid, Spagna, 28040
      • Valencia, Spagna, 46009
    • Bilbao
      • Cruces/Barakaldo, Bilbao, Spagna, 48903
  • Stati Uniti
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85712
    • California
      • Los Angeles, California, Stati Uniti, 90033
      • Los Angeles, California, Stati Uniti, 90057
      • Sacramento, California, Stati Uniti, 95817
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
    • Connecticut
      • Hamden, Connecticut, Stati Uniti, 06518
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30309
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40202
    • Louisiana
      • Lafayette, Louisiana, Stati Uniti, 70506
    • Maryland
      • Frederick, Maryland, Stati Uniti, 21701
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55455
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65203-3244
      • St. Louis, Missouri, Stati Uniti, 63110-1093
    • New York
      • Bronx, New York, Stati Uniti, 10466-2604
      • Brooklyn, New York, Stati Uniti, 11220
      • New York, New York, Stati Uniti, 10032
    • Ohio
      • Canton, Ohio, Stati Uniti, 44718
      • Cleveland, Ohio, Stati Uniti, 44195
      • Dayton, Ohio, Stati Uniti, 45429
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19107-5096
    • South Carolina
      • Spartanburg, South Carolina, Stati Uniti, 29303
    • Texas
      • Dallas, Texas, Stati Uniti, 75246
      • Laredo, Texas, Stati Uniti, 78041
      • San Antonio, Texas, Stati Uniti, 78212
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84132
    • Virginia
      • Richmond, Virginia, Stati Uniti, 23229
    • Washington
      • Seattle, Washington, Stati Uniti, 98101
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226-3596
  • Sud Africa
    • Freestate
      • Bloemfontein, Freestate, Sud Africa, 9300
    • Gauteng
      • Pretoria, Gauteng, Sud Africa
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, Sud Africa, 4001
    • Western Cape
      • Cape Town, Western Cape, Sud Africa, 7500
  • Ucraina
      • Donetsk, Ucraina, 83092
      • Kharkiv, Ucraina, 61024
      • Kiev, Ucraina, 115
      • Lviv, Ucraina, 79031
      • Poltava, Ucraina, 36024
  • Ungheria
      • Budapest, Ungheria, 1121
      • Budapest, Ungheria, 1032
      • Debrecen, Ungheria, 4004
      • Zalaegerszeg, Ungheria, 8900

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:

  • Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
  • Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
  • Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
  • Patients who have adequate coagulation, liver and kidney functions

Exclusion Criteria:

  • Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
  • Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
  • Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
  • Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Patients with a history or presence of metastatic brain or meningeal tumors
  • Patients with seizure disorder requiring medication (such as anti-epileptics)
  • History of organ allograft or bone marrow transplant of stem cell rescue
  • Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control

  • Patients who have three or more of the following:

    • ECOG performance status greater than or equal to 2,
    • Abnormally high lactate dehydrogenase,
    • Abnormally high serum hemoglobin,
    • Abnormally high corrected serum calcium,
    • Absence of prior nephrectomy

  • Excluded therapies and medications, previous and concomitant:

    • Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
    • Significant surgery with 4 weeks of start of study
    • Investigational drug therapy during or within 30 days
    • Concomitant treatment with rifampin or St. John's Wort
    • Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
    • Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors

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 parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Sorafenib (Nexavar, BAY43-9006)
Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
Droga: Sorafenib (Nexavar, BAY43-9006)
Multi Kinase Inhibitor
Comparatore placebo: Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
Droga: Placebo
Placebo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
Lasso di tempo: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population
Lasso di tempo: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Final Progression-Free Survival (PFS) - Independent Radiological Review
Lasso di tempo: From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.
From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
Best Overall Response - Independent Radiological Review
Lasso di tempo: From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.
From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment
Lasso di tempo: From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL.
From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment
Lasso di tempo: From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.
From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.

Collaboratori e investigatori

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

Sponsor

Bayer

Collaboratori

Amgen

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

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 novembre 2003

Completamento primario (Effettivo)

1 settembre 2006

Completamento dello studio (Effettivo)

1 aprile 2010

Date di iscrizione allo studio

Primo inviato

19 novembre 2003

Primo inviato che soddisfa i criteri di controllo qualità

20 novembre 2003

Primo Inserito (Stima)

21 novembre 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 febbraio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 gennaio 2014

Ultimo verificato

1 gennaio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 11213

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, cellule renali

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Saudi Arabia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi