Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
NCT ID: NCT00984282
Last Updated: 2018-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
417 participants
INTERVENTIONAL
2009-10-15
2017-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sorafenib (Nexavar, BAY43-9006)
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
Placebo
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
Placebo
Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).
Interventions
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Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
Placebo
Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).
Eligibility Criteria
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Inclusion Criteria
* Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are eligible provided that the histology has no medullary differentiation nor anaplastic features
* Progression within 14 months (RECIST \[Response Evaluation Criteria in Solid Tumors\] should be used as a basis for the assessment of disease progression)
* RAI (radioactive iodine) refractory
Exclusion Criteria
* Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF (vascular endothelial growth factor) or VEGF Receptors or other targeted agents
* Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose chemotherapy for radiosensitization is allowed) or Thalidomide or any of its derivatives
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Los Angeles, California, United States
Stanford, California, United States
New Haven, Connecticut, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
Seattle, Washington, United States
Vienna, , Austria
Bruxelles - Brussel, , Belgium
Sofia, , Bulgaria
Guangzhou, Guangdong, China
Beijing, , China
Beijing, , China
Chengdu, , China
Hangzhou, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Odense C, , Denmark
Angers, , France
Bordeaux, , France
Caen, , France
Lille, , France
Lyon, , France
Marseille, , France
Paris, , France
Villejuif, , France
Erlangen, Bavaria, Germany
München, Bavaria, Germany
Würzburg, Bavaria, Germany
Cologne, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Leipzig, Saxony, Germany
Napoli, Campania, Italy
Genoa, Liguria, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Catania, Sicily, Italy
Pisa, Tuscany, Italy
Siena, Tuscany, Italy
Perugia, Umbria, Italy
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Kashiwa, Chiba, Japan
Koto-ku, Tokyo, Japan
Groningen, , Netherlands
Leiden, , Netherlands
Gliwice, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Obninsk, , Russia
Riyadh, , Saudi Arabia
Asan Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Daejeon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Majadahonda, Madrid, Spain
Barcelona, , Spain
Gothenburg, , Sweden
Linköping, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Aberdeen, Aberdeenshire, United Kingdom
Cardiff, , United Kingdom
Glasgow, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Sutton, , United Kingdom
Countries
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References
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Worden F, Fassnacht M, Shi Y, Hadjieva T, Bonichon F, Gao M, Fugazzola L, Ando Y, Hasegawa Y, Park DJ, Shong YK, Smit JW, Chung J, Kappeler C, Meinhardt G, Schlumberger M, Brose MS. Safety and tolerability of sorafenib in patients with radioiodine-refractory thyroid cancer. Endocr Relat Cancer. 2015 Dec;22(6):877-87. doi: 10.1530/ERC-15-0252.
Brose MS, Nutting CM, Jarzab B, Elisei R, Siena S, Bastholt L, de la Fouchardiere C, Pacini F, Paschke R, Shong YK, Sherman SI, Smit JW, Chung J, Kappeler C, Pena C, Molnar I, Schlumberger MJ; DECISION investigators. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014 Jul 26;384(9940):319-28. doi: 10.1016/S0140-6736(14)60421-9. Epub 2014 Apr 24.
Brose MS, Nutting CM, Sherman SI, Shong YK, Smit JW, Reike G, Chung J, Kalmus J, Kappeler C, Schlumberger M. Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer. BMC Cancer. 2011 Aug 11;11:349. doi: 10.1186/1471-2407-11-349.
Brose MS, Schlumbeger M, Jeffers M, Kappeler C, Meinhardt G, Pena CEA. Analysis of Biomarkers and Association With Clinical Outcomes in Patients With Differentiated Thyroid Cancer: Subanalysis of the Sorafenib Phase III DECISION Trial. Clin Cancer Res. 2019 Dec 15;25(24):7370-7380. doi: 10.1158/1078-0432.CCR-18-3439. Epub 2019 Sep 26.
Capdevila J, Matos I, Mancuso FM, Iglesias C, Nuciforo P, Zafon C, Palmer HG, Ogbah Z, Muinos L, Hernando J, Villacampa G, Pena CE, Tabernero J, Brose MS, Schlumberger M, Vivancos A. Identification of Expression Profiles Defining Distinct Prognostic Subsets of Radioactive-Iodine Refractory Differentiated Thyroid Cancer from the DECISION Trial. Mol Cancer Ther. 2020 Jan;19(1):312-317. doi: 10.1158/1535-7163.MCT-19-0211. Epub 2019 Sep 20.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2009-012007-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14295
Identifier Type: -
Identifier Source: org_study_id
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