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

8 januari 2014 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Werkelijk)

903

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Capital Federal-Buenos Aires, Argentinië, C1426ANZ
      • Mendoza, Argentinië, 5500
    • Santa Fe
      • Rosario, Santa Fe, Argentinië, S2000DSK
      • Santa Fé, Santa Fe, Argentinië, S3000FFV
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australië, 2605
    • New South Wales
      • Camperdown, New South Wales, Australië, 2050
      • Liverpool, New South Wales, Australië, 2170
      • Westmead, New South Wales, Australië, 2145
    • Victoria
      • Heidelberg, Victoria, Australië, 3084
      • Wodonga, Victoria, Australië, 0390
      • Bruxelles - Brussel, België, 1000
      • Bruxelles - Brussel, België, 1090
    • Parana
      • Curitiba, Parana, Brazilië, 81520-060
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90619900
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90020-060
    • 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
      • Santiago de Chile, Chili
      • Berlin, Duitsland, 10967
      • Hamburg, Duitsland, 20246
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Duitsland, 68167
      • Ulm, Baden-Württemberg, Duitsland, 89075
    • Bayern
      • München, Bayern, Duitsland, 81377
      • Regensburg, Bayern, Duitsland, 93042
    • Hessen
      • Darmstadt, Hessen, Duitsland, 64276
      • Frankfurt, Hessen, Duitsland, 60488
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Duitsland, 40225
    • Sachsen
      • Dresden, Sachsen, Duitsland, 01307
      • Bordeaux, Frankrijk, 33000
      • Caen Cedex 5, Frankrijk, 14076
      • Lille Cedex, Frankrijk, 59020
      • Lyon Cedex, Frankrijk, 69008
      • Marseille, Frankrijk, 13273
      • Nantes, Frankrijk, 44805
      • Paris Cedex 15, Frankrijk, 75908
      • Strasbourg, Frankrijk, 67091
      • Toulouse, Frankrijk, 31052
      • Villejuif, Frankrijk, 94805
      • Budapest, Hongarije, 1121
      • Budapest, Hongarije, 1032
      • Debrecen, Hongarije, 4004
      • Zalaegerszeg, Hongarije, 8900
      • Haifa, Israël, 3109601
      • Tel Aviv, Israël, 64239
      • Milano, Italië, 20133
      • Modena, Italië, 41124
      • Pavia, Italië, 27100
      • Perugia, Italië, 06122
      • Reggio Emilia, Italië, 42100
      • Roma, Italië, 00144
      • Nijmegen, Nederland, 6525 GA
      • Donetsk, Oekraïne, 83092
      • Kharkiv, Oekraïne, 61024
      • Kiev, Oekraïne, 115
      • Lviv, Oekraïne, 79031
      • Poltava, Oekraïne, 36024
      • 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
      • Barnaul, Russische Federatie, 656049
      • Kazan, Russische Federatie, 420029
      • Kirov, Russische Federatie, 610021
      • Moscow, Russische Federatie, 125284
      • Moscow, Russische Federatie, 115478
      • Obninsk, Russische Federatie, 249036
      • St. Petersburg, Russische Federatie, 198255
      • Barcelona, Spanje, 08035
      • Madrid, Spanje, 28040
      • Valencia, Spanje, 46009
    • Bilbao
      • Cruces/Barakaldo, Bilbao, Spanje, 48903
      • Manchester, Verenigd Koninkrijk, M20 4BX
    • Middlesex
      • Northwood, Middlesex, Verenigd Koninkrijk, HA6 2RN
    • South Glamorgan
      • Cardiff, South Glamorgan, Verenigd Koninkrijk, CF14 2TL
    • Stratchclyde
      • Glasgow, Stratchclyde, Verenigd Koninkrijk, G11 6NT
    • Surrey
      • Sutton, Surrey, Verenigd Koninkrijk, SM2 5PT
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, Verenigd Koninkrijk, NE4 6BE
    • West Midlands
      • Birmingham, West Midlands, Verenigd Koninkrijk, B15 2TT
    • Arizona
      • Tucson, Arizona, Verenigde Staten, 85712
    • California
      • Los Angeles, California, Verenigde Staten, 90033
      • Los Angeles, California, Verenigde Staten, 90057
      • Sacramento, California, Verenigde Staten, 95817
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
    • Connecticut
      • Hamden, Connecticut, Verenigde Staten, 06518
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30309
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
    • Kentucky
      • Louisville, Kentucky, Verenigde Staten, 40202
    • Louisiana
      • Lafayette, Louisiana, Verenigde Staten, 70506
    • Maryland
      • Frederick, Maryland, Verenigde Staten, 21701
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55455
    • Missouri
      • Columbia, Missouri, Verenigde Staten, 65203-3244
      • St. Louis, Missouri, Verenigde Staten, 63110-1093
    • New York
      • Bronx, New York, Verenigde Staten, 10466-2604
      • Brooklyn, New York, Verenigde Staten, 11220
      • New York, New York, Verenigde Staten, 10032
    • Ohio
      • Canton, Ohio, Verenigde Staten, 44718
      • Cleveland, Ohio, Verenigde Staten, 44195
      • Dayton, Ohio, Verenigde Staten, 45429
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19107-5096
    • South Carolina
      • Spartanburg, South Carolina, Verenigde Staten, 29303
    • Texas
      • Dallas, Texas, Verenigde Staten, 75246
      • Laredo, Texas, Verenigde Staten, 78041
      • San Antonio, Texas, Verenigde Staten, 78212
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84132
    • Virginia
      • Richmond, Virginia, Verenigde Staten, 23229
    • Washington
      • Seattle, Washington, Verenigde Staten, 98101
    • Wisconsin
      • Milwaukee, Wisconsin, Verenigde Staten, 53226-3596
    • Freestate
      • Bloemfontein, Freestate, Zuid-Afrika, 9300
    • Gauteng
      • Pretoria, Gauteng, Zuid-Afrika
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, Zuid-Afrika, 4001
    • Western Cape
      • Cape Town, Western Cape, Zuid-Afrika, 7500

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Multi Kinase Inhibitor
Placebo-vergelijker: Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
Placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Final Progression-Free Survival (PFS) - Independent Radiological Review
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medewerkers

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2003

Primaire voltooiing (Werkelijk)

1 september 2006

Studie voltooiing (Werkelijk)

1 april 2010

Studieregistratiedata

Eerst ingediend

19 november 2003

Eerst ingediend dat voldeed aan de QC-criteria

20 november 2003

Eerst geplaatst (Schatting)

21 november 2003

Updates van studierecords

Laatste update geplaatst (Schatting)

6 februari 2014

Laatste update ingediend die voldeed aan QC-criteria

8 januari 2014

Laatst geverifieerd

1 januari 2014

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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