check_circleStudy Completed

Carcinoma, Renal Cell

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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
903
Trial Dates
November 2003 - April 2010
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Royal Prince Alfred HospitalCamperdown, 2050, Australia
Completed
UZ BrusselBRUXELLES - BRUSSEL, 1090, Belgium
Completed
Hospital Sao Lucas da Pontificia Universidade Catolica do RSPorto Alegre, 90619900, Brazil
Completed
Cross Cancer InstituteEdmonton, T6G 1Z2, Canada
Completed
Universitätsklinikum UlmUlm, 89075, Germany
Completed
Instituto Valenciano de OncologíaValencia, 46009, Spain
Completed
Velindre HospitalCardiff, CF14 2TL, United Kingdom
Completed
Universitair Medisch Centrum St. RadboudNIJMEGEN, 6525 GA, Netherlands
Completed
Hertzen Institute of OncologyMoscow, 125284, Russia
Completed
Regional Cancer DispensaryPoltava, 36024, Ukraine
Completed
Centro Oncológico de RosarioRosario, S2000DSK, Argentina
Completed
Austin HealthHeidelberg, 3084, Australia
Completed
Institut Jules Bordet/Jules Bordet InstituutBRUXELLES - BRUSSEL, 1000, Belgium
Completed
Liga Paranaense de Combate ao Cancer-Hosp Erasto GaertnerCuritiba, 81520-060, Brazil
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Centro Especializado ISISSanta Fé, S3000FFV, Argentina
Completed
Hospital Clínico Universidad de ChileSantiago de Chile, Chile
Completed
Institut Gustave Roussy - VillejuifVILLEJUIF, 94805, France
Completed
Zala Megyei KorhazZalaegerszeg, 8900, Hungary
Completed
Rambam Medical CenterHaifa, 3109601, Israel
Completed
IRCCS Istituti Fisioterapici OspitalieriRoma, 00144, Italy
Completed
Centrum Onkologii - Instytut im. M.Sklodowskiej-CurieWarszawa, 02-781, Poland
Completed
Mary Potter Oncology CentrePretoria, South Africa
Completed
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
A.O. di Reggio EmiliaReggio Emilia, 42100, Italy
Completed
Donetsk Regional Oncological Center Regional Antitumor CenteDonetsk, 83092, Ukraine
Completed
Westmead HospitalWestmead, 2145, Australia
Completed
Hospital de CrucesCruces/Barakaldo, 48903, Spain
Completed
Hopital Européen Georges Pompidou - ParisPARIS CEDEX 15, 75908, France
Completed
Centre François Baclesse - CLCC - CaenCAEN CEDEX 5, 14076, France
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Akademia Medyczna we WroclawiuWroclaw, 50-043, Poland
Completed
City Clinical Oncology CenterSt. Petersburg, 198255, Russia
Completed
Louisiana Oncology Associates, PMCLafayette, 70506, United States
Completed
Instituto Medico Especializado Alexander FlemingCapital Federal-Buenos Aires, C1426ANZ, Argentina
Completed
Irmandade Santa Casa de Misericordia de Porto AlegrePorto Alegre, 90020-060, Brazil
Completed
Princess Margaret Hospital-University Health NetworkToronto, M5G 2M9, Canada
Completed
National Institute of OncologyBudapest, 1121, Hungary
Completed
Addington Hospital DurbanDurban, 4001, South Africa
Completed
Liverpool HospitalLiverpool, 2170, Australia
Completed
Juravinski Cancer CentreHamilton, L8V 5C2, Canada
Completed
Universitätsklinikum RegensburgRegensburg, 93042, Germany
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Christie HospitalManchester, M20 4BX, United Kingdom
Completed
Newcastle General HospitalNewcastle Upon Tyne, NE4 6BE, United Kingdom
Completed
Samodzielny Publiczn Szpital Kliniczny nr 2 PUM w SzczecinieSzczecin, 70-111, Poland
Completed
Clinical Oncology DispensaryKazan, 420029, Russia
Completed
City Oncology HospitalKiev, 115, Ukraine
Completed
University of Utah Medical CenterSalt Lake City, 84132, United States
Completed
Fundación Centro Oncológico de Integración RegionalMendoza, 5500, Argentina
Completed
Hôpital Saint André - BordeauxBORDEAUX, 33000, France
Completed
Szent Margit HospitalBudapest, 1032, Hungary
Completed
Wojewodzkie Centrum OnkologiiGdansk, 80-210, Poland
Completed
The Canberra HospitalGarran, 2605, Australia
Completed
Institut Claudius Regaud - ToulouseTOULOUSE, 31052, France
Completed
University of Debrecen Medical&Health Science CenterDebrecen, 4004, Hungary
Completed
Akademia MedycznaPoznan, 61-878, Poland
Completed
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMSMoscow, 115478, Russia
Completed
Grigoriev Institute for medical radiologyKharkiv, 61024, Ukraine
Completed
Klinikum DarmstadtDarmstadt, 64276, Germany
Completed
Altay Oncological DispensaryBarnaul, 656049, Russia
Completed
Lvov Cancer CenterLviv, 79031, Ukraine
Completed
Palmetto Hematology Oncology, PCSpartanburg, 29303, United States
Completed
London Regional Cancer ProgramLondon, N6A 4L6, Canada
Completed
Mount Vernon HospitalNorthwood, HA6 2RN, United Kingdom
Completed
IRCCS Istituto Nazionale TumoriMilano, 20133, Italy
Completed
Murray Valley Private HospitalWodonga, 0390, Australia
Completed
Centre Oscar Lambret - LilleLILLE CEDEX, 59020, France
Completed
Virginia Physicians, Inc.Richmond, 23229, United States
Completed
Centre Léon BérardLYON CEDEX, 69008, France
Completed
University of BirminghamBirmingham, B15 2TT, United Kingdom
Completed
Kirov Regional Clinical Oncology DispensaryKirov, 610021, Russia
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Institut Paoli-Calmettes - MarseilleMARSEILLE, 13273, France
Completed
Virginia Mason Medical CenterSeattle, 98101, United States
Completed
Kentuckiana Cancer Institute, PLLCLouisville, 40202, United States
Completed
Western InfirmaryGlasgow, G11 6NT, United Kingdom
Completed
A.O.U. di Modena PoliclinicoModena, 41124, Italy
Completed
Petrov Research Instutute of OncologySt. Petersburg, 198255, Russia
Completed
University of StellenboschCape Town, 7500, South Africa
Completed
Vivantes Klinikum Am UrbanBerlin, 10967, Germany
Completed
A.O. di PerugiaPerugia, 06122, Italy
Completed
Centrum Onkologii Ziemi LubelskiejLublin, 20-090, Poland
Completed
Medical Radiol. Research Centre of Minzdravsocrazvitie, FGBUObninsk, 249036, Russia
Completed
Universitas HospitalBloemfontein, 9300, South Africa
Completed
Centre René Gauducheau - NantesNANTES, 44805, France
Completed
IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
Regionalny Osrodek Onkologiczny - Wojew. Szpital OnkolgicznyLodz, 93-509, Poland
Completed
University of Missouri HealthCareColumbia, 65203-3244, United States
Completed
Centrum Onkologii Instytut im. M. Sklodowskiej-CurieKrakow, 31-115, Poland
Completed
Hôpital Civil - StrasbourgSTRASBOURG, 67091, France
Completed
Wojskowy Instytut MedycznyWarszawa, 04-141, Poland
Completed
Klinikum Mannheim gGmbHMannheim, 68167, Germany
Completed
Arizona Clinical Research CenterTucson, 85712, United States
Completed
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20246, Germany
Completed
Washington University School of MedicineSt. Louis, 63110-1093, United States
Completed
Krankenhaus NordwestFrankfurt, 60488, Germany
Completed
Optima Research, LtdLaredo, 78041, United States
Completed
The Cleveland ClinicCleveland, 44195, United States
Completed
Hematology & Oncology of Dayton, Inc.Dayton, 45429, United States
Completed
Maimonides Medical CenterBrooklyn, 11220, United States
Completed
University of ChicagoChicago, 60637, United States
Completed
Frederick Memorial HospitalFrederick, 21701, United States
Completed
Beth Israel Deaconess Medical CenterBoston, 02215, United States
Completed
Our Lady of Mercy Medical CenterBronx, 10466-2604, United States
Completed
Baylor Sammons Cancer Center at DallasDallas, 75246, United States
Completed
Peachtree Hematology & Oncology Consultants, PCAtlanta, 30309, United States
Completed
Oregon Health and Science UniversityPortland, 97239, United States
Completed
New York-Presbyterian HospitalNew York, 10032, United States
Completed
University of Colorado Health Sciences CenterAurora, 80045, United States
Completed
LMU Klinikum der Universität München - GroßhadernMünchen, 81377, Germany
Completed
Kenmar Research InstituteLos Angeles, 90057, United States
Completed
Medizinische Einrichtungen der Heinrich-Heine-UniversitätDüsseldorf, 40225, Germany
Completed
University of Southern CaliforniaLos Angeles, 90033, United States
Completed
University of Minnesota Medical Center-FairviewMinneapolis, 55455, United States
Completed
Thomas Jefferson University HospitalsPhiladelphia, 19107-5096, United States
Completed
Gabrail Cancer CenterCanton, 44718, United States
Completed
Cancer Care Centers of South TexasSan Antonio, 78212, United States
Completed
Froedtert Memorial Lutheran HospitalMilwaukee, 53226-3596, United States
Completed
University of California - DavisSacramento, 95817, United States
Completed
Medical Oncology & Hematology, PCHamden, 06518, United States

Primary Outcome

  • Final Overall Survival - Primary Analysis in the ITT (Intent To Treat) population
    date_rangeTime Frame:
    From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
    enhanced_encryption
    Safety Issue:
    No
  • Final Overall Survival - Secondary Analysis (Placebo data censored at 30June2005) in the ITT population
    date_rangeTime Frame:
    From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Final Progression-Free Survival (PFS) - Independent radiological review
    date_rangeTime Frame:
    From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Best Overall Response - Independent radiological review
    date_rangeTime Frame:
    From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
    enhanced_encryption
    Safety Issue:
    No
  • Health-related quality of life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) assessment
    date_rangeTime Frame:
    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.
    enhanced_encryption
    Safety Issue:
    No
  • Health-related quality of life (HRQOL) by Physical Well-Being (PWB) score of the FACT-G (Functional Assessment of Cancer Therapy-General version) assessment
    date_rangeTime Frame:
    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.
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Phase III randomized study of BAY43-9006 in patients with unresectable and/or metastatic renal cell cancer.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2