Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
8 de enero de 2014 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Overall Survival (OS), Patient-reported outcome (PRO)
Tipo de estudio
Intervencionista
Inscripción (Actual)
903
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 10967
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Hamburg, Alemania, 20246
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Baden-Württemberg
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Mannheim, Baden-Württemberg, Alemania, 68167
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Ulm, Baden-Württemberg, Alemania, 89075
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Bayern
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München, Bayern, Alemania, 81377
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Regensburg, Bayern, Alemania, 93042
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Hessen
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Darmstadt, Hessen, Alemania, 64276
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Frankfurt, Hessen, Alemania, 60488
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Nordrhein-Westfalen
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Düsseldorf, Nordrhein-Westfalen, Alemania, 40225
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Sachsen
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Dresden, Sachsen, Alemania, 01307
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Capital Federal-Buenos Aires, Argentina, C1426ANZ
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Mendoza, Argentina, 5500
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DSK
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Santa Fé, Santa Fe, Argentina, S3000FFV
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Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2605
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New South Wales
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Camperdown, New South Wales, Australia, 2050
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Liverpool, New South Wales, Australia, 2170
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Westmead, New South Wales, Australia, 2145
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Victoria
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Heidelberg, Victoria, Australia, 3084
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Wodonga, Victoria, Australia, 0390
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Parana
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Curitiba, Parana, Brasil, 81520-060
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90619900
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Porto Alegre, Rio Grande do Sul, Brasil, 90020-060
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Bruxelles - Brussel, Bélgica, 1000
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Bruxelles - Brussel, Bélgica, 1090
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Alberta
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Edmonton, Alberta, Canadá, T6G 1Z2
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Ontario
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Hamilton, Ontario, Canadá, L8V 5C2
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London, Ontario, Canadá, N6A 4L6
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Toronto, Ontario, Canadá, M5G 2M9
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Quebec
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Montreal, Quebec, Canadá, H3T 1E2
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Santiago de Chile, Chile
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Barcelona, España, 08035
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Madrid, España, 28040
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Valencia, España, 46009
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Bilbao
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Cruces/Barakaldo, Bilbao, España, 48903
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Arizona
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Tucson, Arizona, Estados Unidos, 85712
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California
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Los Angeles, California, Estados Unidos, 90033
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Los Angeles, California, Estados Unidos, 90057
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Sacramento, California, Estados Unidos, 95817
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
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Connecticut
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Hamden, Connecticut, Estados Unidos, 06518
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Georgia
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Atlanta, Georgia, Estados Unidos, 30309
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
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Louisiana
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Lafayette, Louisiana, Estados Unidos, 70506
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Maryland
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Frederick, Maryland, Estados Unidos, 21701
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
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Missouri
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Columbia, Missouri, Estados Unidos, 65203-3244
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St. Louis, Missouri, Estados Unidos, 63110-1093
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New York
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Bronx, New York, Estados Unidos, 10466-2604
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Brooklyn, New York, Estados Unidos, 11220
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New York, New York, Estados Unidos, 10032
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Ohio
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Canton, Ohio, Estados Unidos, 44718
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Cleveland, Ohio, Estados Unidos, 44195
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Dayton, Ohio, Estados Unidos, 45429
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Oregon
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Portland, Oregon, Estados Unidos, 97239
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107-5096
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South Carolina
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Spartanburg, South Carolina, Estados Unidos, 29303
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Texas
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Dallas, Texas, Estados Unidos, 75246
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Laredo, Texas, Estados Unidos, 78041
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San Antonio, Texas, Estados Unidos, 78212
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
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Virginia
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Richmond, Virginia, Estados Unidos, 23229
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Washington
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Seattle, Washington, Estados Unidos, 98101
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226-3596
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Barnaul, Federación Rusa, 656049
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Kazan, Federación Rusa, 420029
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Kirov, Federación Rusa, 610021
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Moscow, Federación Rusa, 125284
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Moscow, Federación Rusa, 115478
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Obninsk, Federación Rusa, 249036
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St. Petersburg, Federación Rusa, 198255
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Bordeaux, Francia, 33000
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Caen Cedex 5, Francia, 14076
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Lille Cedex, Francia, 59020
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Lyon Cedex, Francia, 69008
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Marseille, Francia, 13273
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Nantes, Francia, 44805
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Paris Cedex 15, Francia, 75908
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Strasbourg, Francia, 67091
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Toulouse, Francia, 31052
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Villejuif, Francia, 94805
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Budapest, Hungría, 1121
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Budapest, Hungría, 1032
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Debrecen, Hungría, 4004
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Zalaegerszeg, Hungría, 8900
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Haifa, Israel, 3109601
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Tel Aviv, Israel, 64239
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Milano, Italia, 20133
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Modena, Italia, 41124
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Pavia, Italia, 27100
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Perugia, Italia, 06122
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Reggio Emilia, Italia, 42100
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Roma, Italia, 00144
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Nijmegen, Países Bajos, 6525 GA
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Gdansk, Polonia, 80-210
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Krakow, Polonia, 31-115
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Lodz, Polonia, 93-509
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Lublin, Polonia, 20-090
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Poznan, Polonia, 61-878
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Szczecin, Polonia, 70-111
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Warszawa, Polonia, 02-781
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Warszawa, Polonia, 04-141
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Wroclaw, Polonia, 50-043
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Manchester, Reino Unido, M20 4BX
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Middlesex
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Northwood, Middlesex, Reino Unido, HA6 2RN
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South Glamorgan
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Cardiff, South Glamorgan, Reino Unido, CF14 2TL
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Stratchclyde
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Glasgow, Stratchclyde, Reino Unido, G11 6NT
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Surrey
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Sutton, Surrey, Reino Unido, SM2 5PT
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Tyne and Wear
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Newcastle Upon Tyne, Tyne and Wear, Reino Unido, NE4 6BE
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West Midlands
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Birmingham, West Midlands, Reino Unido, B15 2TT
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Freestate
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Bloemfontein, Freestate, Sudáfrica, 9300
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Gauteng
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Pretoria, Gauteng, Sudáfrica
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Kwazulu-Natal
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Durban, Kwazulu-Natal, Sudáfrica, 4001
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Western Cape
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Cape Town, Western Cape, Sudáfrica, 7500
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Donetsk, Ucrania, 83092
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Kharkiv, Ucrania, 61024
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Kiev, Ucrania, 115
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Lviv, Ucrania, 79031
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Poltava, Ucrania, 36024
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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Multi Kinase Inhibitor
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Comparador de placebos: Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
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Placebo
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
Periodo de tiempo: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
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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.
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From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
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Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population
Periodo de tiempo: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
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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.
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From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Final Progression-Free Survival (PFS) - Independent Radiological Review
Periodo de tiempo: From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
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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.
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From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
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Best Overall Response - Independent Radiological Review
Periodo de tiempo: From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
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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.
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From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
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Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment
Periodo de tiempo: 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.
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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.
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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.
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Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment
Periodo de tiempo: 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.
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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.
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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.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Quintanilha JCF, Geyer S, Etheridge AS, Racioppi A, Hammond K, Crona DJ, Pena CE, Jacobson SB, Marmorino F, Rossini D, Cremolini C, Sanoff HK, Abou-Alfa GK, Innocenti F. KDR genetic predictor of toxicities induced by sorafenib and regorafenib. Pharmacogenomics J. 2022 Dec;22(5-6):251-257. doi: 10.1038/s41397-022-00279-3. Epub 2022 Apr 28.
- Antoun S, Birdsell L, Sawyer MB, Venner P, Escudier B, Baracos VE. Association of skeletal muscle wasting with treatment with sorafenib in patients with advanced renal cell carcinoma: results from a placebo-controlled study. J Clin Oncol. 2010 Feb 20;28(6):1054-60. doi: 10.1200/JCO.2009.24.9730. Epub 2010 Jan 19.
- Bellmunt J, Eisen T, Fishman M, Quinn D. Experience with sorafenib and adverse event management. Crit Rev Oncol Hematol. 2011 Apr;78(1):24-32. doi: 10.1016/j.critrevonc.2010.03.006. Epub 2010 Apr 18.
- Massard C, Zonierek J, Gross-Goupil M, Fizazi K, Szczylik C, Escudier B. Incidence of brain metastases in renal cell carcinoma treated with sorafenib. Ann Oncol. 2010 May;21(5):1027-31. doi: 10.1093/annonc/mdp411. Epub 2009 Oct 22.
- Negrier S, Jager E, Porta C, McDermott D, Moore M, Bellmunt J, Anderson S, Cihon F, Lewis J, Escudier B, Bukowski R. Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET. Med Oncol. 2010 Sep;27(3):899-906. doi: 10.1007/s12032-009-9303-z. Epub 2009 Sep 12.
- Pena C, Lathia C, Shan M, Escudier B, Bukowski RM. Biomarkers predicting outcome in patients with advanced renal cell carcinoma: Results from sorafenib phase III Treatment Approaches in Renal Cancer Global Evaluation Trial. Clin Cancer Res. 2010 Oct 1;16(19):4853-63. doi: 10.1158/1078-0432.CCR-09-3343. Epub 2010 Jul 22.
- Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM. Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009 Jul 10;27(20):3312-8. doi: 10.1200/JCO.2008.19.5511. Epub 2009 May 18.
- Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R, Cihon F, Anderson S, Shah S, Bukowski R, Escudier B; TARGET Study Group. Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial. J Natl Cancer Inst. 2008 Oct 15;100(20):1454-63. doi: 10.1093/jnci/djn319. Epub 2008 Oct 7.
- Bukowski R, Cella D, Gondek K, Escudier B; Sorafenib TARGETs Clinical Trial Group. Effects of sorafenib on symptoms and quality of life: results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol. 2007 Jun;30(3):220-7. doi: 10.1097/01.coc.0000258732.80710.05.
- Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. doi: 10.1056/NEJMoa060655. Erratum In: N Engl J Med. 2007 Jul 12;357(2):203.
- Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, Liang C, Booth B, Chidambaram N, Morse D, Sridhara R, Garvey P, Justice R, Pazdur R. Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res. 2006 Dec 15;12(24):7271-8. doi: 10.1158/1078-0432.CCR-06-1249.
- Lamuraglia M, Escudier B, Chami L, Schwartz B, Leclere J, Roche A, Lassau N. To predict progression-free survival and overall survival in metastatic renal cancer treated with sorafenib: pilot study using dynamic contrast-enhanced Doppler ultrasound. Eur J Cancer. 2006 Oct;42(15):2472-9. doi: 10.1016/j.ejca.2006.04.023. Epub 2006 Sep 11. Erratum In: Eur J Cancer. 2007 May;43(8):1336.
- Quintanilha JCF, Racioppi A, Wang J, Etheridge AS, Denning S, Pena CE, Skol AD, Crona DJ, Lin D, Innocenti F. PIK3R5 genetic predictors of hypertension induced by VEGF-pathway inhibitors. Pharmacogenomics J. 2022 Feb;22(1):82-88. doi: 10.1038/s41397-021-00261-5. Epub 2021 Nov 13. Erratum In: Pharmacogenomics J. 2021 Dec 21;:
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2003
Finalización primaria (Actual)
1 de septiembre de 2006
Finalización del estudio (Actual)
1 de abril de 2010
Fechas de registro del estudio
Enviado por primera vez
19 de noviembre de 2003
Primero enviado que cumplió con los criterios de control de calidad
20 de noviembre de 2003
Publicado por primera vez (Estimar)
21 de noviembre de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de febrero de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
8 de enero de 2014
Última verificación
1 de enero de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias Urológicas
- Neoplasias urogenitales
- Neoplasias por sitio
- Enfermedades Renales
- Enfermedades urológicas
- Adenocarcinoma
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Renales
- Carcinoma De Célula Renal
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Sorafenib
Otros números de identificación del estudio
- 11213
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .