Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
1 other identifier
interventional
903
19 countries
121
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2003
Longer than P75 for phase_3
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 19, 2003
CompletedFirst Posted
Study publicly available on registry
November 21, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
December 14, 2011
CompletedFebruary 6, 2014
January 1, 2014
2.8 years
November 19, 2003
August 2, 2011
January 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
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
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
Secondary Outcomes (4)
Final Progression-Free Survival (PFS) - Independent Radiological Review
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
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
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
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.
Study Arms (2)
Sorafenib (Nexavar, BAY43-9006)
EXPERIMENTALSorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
Placebo
PLACEBO COMPARATORPlacebo tablets matching in appearance were to be orally administered twice a day.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (121)
Unknown Facility
Tucson, Arizona, 85712, United States
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Los Angeles, California, 90033, United States
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Los Angeles, California, 90057, United States
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Sacramento, California, 95817, United States
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Aurora, Colorado, 80045, United States
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Hamden, Connecticut, 06518, United States
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Atlanta, Georgia, 30309, United States
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Chicago, Illinois, 60637, United States
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Louisville, Kentucky, 40202, United States
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Lafayette, Louisiana, 70506, United States
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Frederick, Maryland, 21701, United States
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Boston, Massachusetts, 02215, United States
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Minneapolis, Minnesota, 55455, United States
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Columbia, Missouri, 65203-3244, United States
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St Louis, Missouri, 63110-1093, United States
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Brooklyn, New York, 11220, United States
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New York, New York, 10032, United States
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The Bronx, New York, 10466-2604, United States
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Canton, Ohio, 44718, United States
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Cleveland, Ohio, 44195, United States
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Dayton, Ohio, 45429, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19107-5096, United States
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Spartanburg, South Carolina, 29303, United States
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Dallas, Texas, 75246, United States
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Laredo, Texas, 78041, United States
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San Antonio, Texas, 78212, United States
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Salt Lake City, Utah, 84132, United States
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Richmond, Virginia, 23229, United States
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Seattle, Washington, 98101, United States
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Milwaukee, Wisconsin, 53226-3596, United States
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Rosario, Santa Fe Province, S2000DSK, Argentina
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Santa Fé, Santa Fe Province, S3000FFV, Argentina
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Capital Federal-Buenos Aires, C1426ANZ, Argentina
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Mendoza, 5500, Argentina
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Garran, Australian Capital Territory, 2605, Australia
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Camperdown, New South Wales, 2050, Australia
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Liverpool, New South Wales, 2170, Australia
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Westmead, New South Wales, 2145, Australia
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Heidelberg, Victoria, 3084, Australia
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Wodonga, Victoria, 0390, Australia
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Bruxelles - Brussel, 1000, Belgium
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Bruxelles - Brussel, 1090, Belgium
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Curitiba, Paraná, 81520-060, Brazil
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Porto Alegre, Rio Grande do Sul, 90020-060, Brazil
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Porto Alegre, Rio Grande do Sul, 90619900, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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London, Ontario, N6A 4L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Santiago, Chile
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Bordeaux, 33000, France
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Caen, 14076, France
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Lille, 59020, France
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Lyon, 69008, France
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Marseille, 13273, France
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Nantes, 44805, France
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Paris, 75908, France
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Strasbourg, 67091, France
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Toulouse, 31052, France
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Villejuif, 94805, France
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Mannheim, Baden-Wurttemberg, 68167, Germany
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Ulm, Baden-Wurttemberg, 89075, Germany
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München, Bavaria, 81377, Germany
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Regensburg, Bavaria, 93042, Germany
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Hamburg, Hamburg, 20246, Germany
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Darmstadt, Hesse, 64276, Germany
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Frankfurt am Main, Hesse, 60488, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Dresden, Saxony, 01307, Germany
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Berlin, State of Berlin, 10967, Germany
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Budapest, 1032, Hungary
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Budapest, 1121, Hungary
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Debrecen, 4004, Hungary
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Zalaegerszeg, 8900, Hungary
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Haifa, 3109601, Israel
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Tel Aviv, 64239, Israel
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Milan, 20133, Italy
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Modena, 41124, Italy
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Pavia, 27100, Italy
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Perugia, 06122, Italy
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Reggio Emilia, 42100, Italy
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Roma, 00144, Italy
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Nijmegen, 6525 GA, Netherlands
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Gdansk, 80-210, Poland
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Krakow, 31-115, Poland
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Lodz, 93-509, Poland
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Lublin, 20-090, Poland
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Poznan, 61-878, Poland
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Szczecin, 70-111, Poland
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Warsaw, 02-781, Poland
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Warsaw, 04-141, Poland
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Wroclaw, 50-043, Poland
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Barnaul, 656049, Russia
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Kazan', 420029, Russia
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Kirov, 610021, Russia
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Moscow, 115478, Russia
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Moscow, 125284, Russia
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Obninsk, 249036, Russia
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Saint Petersburg, 198255, Russia
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Bloemfontein, Freestate, 9300, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, 4001, South Africa
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Cape Town, Western Cape, 7500, South Africa
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Barcelona, Barcelona, 08035, Spain
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Cruces/Barakaldo, Bilbao, 48903, Spain
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Madrid, Madrid, 28040, Spain
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Valencia, Valencia, 46009, Spain
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Donetsk, 83092, Ukraine
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Kharkiv, 61024, Ukraine
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Kiev, 115, Ukraine
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Lviv, 79031, Ukraine
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Poltava, 36024, Ukraine
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Manchester, Manchester, M20 4BX, United Kingdom
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Northwood, Middlesex, HA6 2RN, United Kingdom
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Cardiff, South Glamorgan, CF14 2TL, United Kingdom
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Glasgow, Stratchclyde, G11 6NT, United Kingdom
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Sutton, Surrey, SM2 5PT, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, NE4 6BE, United Kingdom
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Birmingham, West Midlands, B15 2TT, United Kingdom
Related Publications (13)
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.
PMID: 20085939RESULTBellmunt 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.
PMID: 20399677RESULTMassard 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.
PMID: 19850637RESULTNegrier 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.
PMID: 19757215RESULTPena 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.
PMID: 20651059RESULTEscudier 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.
PMID: 19451442RESULTEisen 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.
PMID: 18840822RESULTBukowski 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.
PMID: 17551296RESULTEscudier 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.
PMID: 17215530RESULTKane 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.
PMID: 17189398RESULTLamuraglia 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.
PMID: 16965911RESULTQuintanilha 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.
PMID: 35484400DERIVEDQuintanilha 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.
PMID: 34775477DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Per final PFS data (N=769) study unblinded; placebo-randomized subjects switched to sorafenib \~31May2005 (N=216) that diluted final OS, sorafenib treatment effect. Final ITT, N=903, reported safety data include additional data and cleaning.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2003
First Posted
November 21, 2003
Study Start
November 1, 2003
Primary Completion
September 1, 2006
Study Completion
April 1, 2010
Last Updated
February 6, 2014
Results First Posted
December 14, 2011
Record last verified: 2014-01