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

8. januar 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

903

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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

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:

  • 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

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: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Sorafenib (Nexavar, BAY43-9006)
Multi Kinase Inhibitor
Placebo komparator: Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
Medicin: Placebo
Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Final Progression-Free Survival (PFS) - Independent Radiological Review
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

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

Sponsor

Bayer

Samarbejdspartnere

Amgen

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

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. november 2003

Primær færdiggørelse (Faktiske)

1. september 2006

Studieafslutning (Faktiske)

1. april 2010

Datoer for studieregistrering

Først indsendt

19. november 2003

Først indsendt, der opfyldte QC-kriterier

20. november 2003

Først opslået (Skøn)

21. november 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11213

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 .

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