Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
8 de janeiro de 2014 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Overall Survival (OS), Patient-reported outcome (PRO)
Tipo de estudo
Intervencional
Inscrição (Real)
903
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Berlin, Alemanha, 10967
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Hamburg, Alemanha, 20246
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Baden-Württemberg
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Mannheim, Baden-Württemberg, Alemanha, 68167
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Ulm, Baden-Württemberg, Alemanha, 89075
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Bayern
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München, Bayern, Alemanha, 81377
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Regensburg, Bayern, Alemanha, 93042
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Hessen
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Darmstadt, Hessen, Alemanha, 64276
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Frankfurt, Hessen, Alemanha, 60488
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Nordrhein-Westfalen
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Düsseldorf, Nordrhein-Westfalen, Alemanha, 40225
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Sachsen
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Dresden, Sachsen, Alemanha, 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, Austrália, 2605
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New South Wales
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Camperdown, New South Wales, Austrália, 2050
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Liverpool, New South Wales, Austrália, 2170
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Westmead, New South Wales, Austrália, 2145
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Victoria
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Heidelberg, Victoria, Austrália, 3084
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Wodonga, Victoria, Austrália, 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, Espanha, 08035
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Madrid, Espanha, 28040
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Valencia, Espanha, 46009
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Bilbao
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Cruces/Barakaldo, Bilbao, Espanha, 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, Federação Russa, 656049
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Kazan, Federação Russa, 420029
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Kirov, Federação Russa, 610021
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Moscow, Federação Russa, 125284
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Moscow, Federação Russa, 115478
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Obninsk, Federação Russa, 249036
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St. Petersburg, Federação Russa, 198255
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Bordeaux, França, 33000
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Caen Cedex 5, França, 14076
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Lille Cedex, França, 59020
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Lyon Cedex, França, 69008
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Marseille, França, 13273
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Nantes, França, 44805
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Paris Cedex 15, França, 75908
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Strasbourg, França, 67091
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Toulouse, França, 31052
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Villejuif, França, 94805
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Nijmegen, Holanda, 6525 GA
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Budapest, Hungria, 1121
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Budapest, Hungria, 1032
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Debrecen, Hungria, 4004
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Zalaegerszeg, Hungria, 8900
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Haifa, Israel, 3109601
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Tel Aviv, Israel, 64239
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Milano, Itália, 20133
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Modena, Itália, 41124
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Pavia, Itália, 27100
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Perugia, Itália, 06122
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Reggio Emilia, Itália, 42100
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Roma, Itália, 00144
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Gdansk, Polônia, 80-210
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Krakow, Polônia, 31-115
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Lodz, Polônia, 93-509
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Lublin, Polônia, 20-090
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Poznan, Polônia, 61-878
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Szczecin, Polônia, 70-111
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Warszawa, Polônia, 02-781
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Warszawa, Polônia, 04-141
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Wroclaw, Polônia, 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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Donetsk, Ucrânia, 83092
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Kharkiv, Ucrânia, 61024
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Kiev, Ucrânia, 115
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Lviv, Ucrânia, 79031
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Poltava, Ucrânia, 36024
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Freestate
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Bloemfontein, Freestate, África do Sul, 9300
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Gauteng
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Pretoria, Gauteng, África do Sul
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Kwazulu-Natal
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Durban, Kwazulu-Natal, África do Sul, 4001
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Western Cape
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Cape Town, Western Cape, África do Sul, 7500
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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 Placebo: Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
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Placebo
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Final Progression-Free Survival (PFS) - Independent Radiological Review
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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;:
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de novembro de 2003
Conclusão Primária (Real)
1 de setembro de 2006
Conclusão do estudo (Real)
1 de abril de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
19 de novembro de 2003
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de novembro de 2003
Primeira postagem (Estimativa)
21 de novembro de 2003
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
6 de fevereiro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de janeiro de 2014
Última verificação
1 de janeiro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias Urológicas
- Neoplasias urogenitais
- Neoplasias por local
- Doenças renais
- Doenças Urológicas
- Adenocarcinoma
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias Renais
- Carcinoma de Células Renais
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Inibidores de proteína quinase
- Sorafenibe
Outros números de identificação do estudo
- 11213
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .