Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
NCT ID: NCT00073307
Last Updated: 2014-02-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
903 participants
INTERVENTIONAL
2003-11-30
2010-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma
NCT00117637
Research Study for Patients With Metastatic Renal Cell Carcinoma
NCT00110344
An Open-Label, Non-Comparative, Phase III Study of the Raf-Kinase Inhibitor BAY 43-9006 as a Subsequent to First-Line Therapy in Patients With Advanced Renal Cell Carcinoma
NCT00492986
BAY43-9006 Phase II Study for Renal Cell Carcinoma
NCT00661375
Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer
NCT00079612
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Sorafenib (Nexavar, BAY43-9006)
Multi Kinase Inhibitor
Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sorafenib (Nexavar, BAY43-9006)
Multi Kinase Inhibitor
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sutton, Surrey, United Kingdom
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Birmingham, West Midlands, United Kingdom
Lviv, , Ukraine
Poltava, , Ukraine
Manchester, Manchester, United Kingdom
Northwood, Middlesex, United Kingdom
Cardiff, South Glamorgan, United Kingdom
Glasgow, Stratchclyde, United Kingdom
Tucson, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Aurora, Colorado, United States
Hamden, Connecticut, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Lafayette, Louisiana, United States
Frederick, Maryland, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
Brooklyn, New York, United States
New York, New York, United States
The Bronx, New York, United States
Canton, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Spartanburg, South Carolina, United States
Dallas, Texas, United States
Laredo, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Rosario, Santa Fe Province, Argentina
Santa Fé, Santa Fe Province, Argentina
Capital Federal-Buenos Aires, , Argentina
Mendoza, , Argentina
Garran, Australian Capital Territory, Australia
Camperdown, New South Wales, Australia
Liverpool, New South Wales, Australia
Westmead, New South Wales, Australia
Heidelberg, Victoria, Australia
Wodonga, Victoria, Australia
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Santiago, , Chile
Bordeaux, , France
Caen, , France
Lille, , France
Lyon, , France
Marseille, , France
Nantes, , France
Paris, , France
Strasbourg, , France
Toulouse, , France
Villejuif, , France
Mannheim, Baden-Wurttemberg, Germany
Ulm, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Regensburg, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Darmstadt, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Berlin, State of Berlin, Germany
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Zalaegerszeg, , Hungary
Haifa, , Israel
Tel Aviv, , Israel
Milan, , Italy
Modena, , Italy
Pavia, , Italy
Perugia, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Nijmegen, , Netherlands
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Szczecin, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Barnaul, , Russia
Kazan', , Russia
Kirov, , Russia
Moscow, , Russia
Moscow, , Russia
Obninsk, , Russia
Saint Petersburg, , Russia
Bloemfontein, Freestate, South Africa
Pretoria, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Barcelona, Barcelona, Spain
Cruces/Barakaldo, Bilbao, Spain
Madrid, Madrid, Spain
Valencia, Valencia, Spain
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11213
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.