Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
2 other identifiers
interventional
417
18 countries
81
Brief Summary
Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2009
Longer than P75 for phase_3
81 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
First Submitted
Initial submission to the registry
September 24, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedStudy Start
First participant enrolled
October 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2012
CompletedResults Posted
Study results publicly available
December 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2017
CompletedSeptember 13, 2018
August 1, 2018
2.9 years
September 24, 2009
August 19, 2013
August 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.
Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years
Secondary Outcomes (7)
Overall Survival (OS)
From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Disease Control Rate (DCR) Based on Central Assessment
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Response Rate Based on Central Assessment
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Duration of Response (DOR) Based on Central Assessment
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
- +2 more secondary outcomes
Study Arms (2)
Sorafenib (Nexavar, BAY43-9006)
EXPERIMENTALParticipants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
Placebo
PLACEBO COMPARATORParticipants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
Interventions
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).
Eligibility Criteria
You may qualify if:
- Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell)
- 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
You may not qualify if:
- Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Unknown Facility
Los Angeles, California, 90048, United States
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Stanford, California, 94305-5820, United States
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New Haven, Connecticut, 06520, United States
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Atlanta, Georgia, 30322, United States
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Boston, Massachusetts, 02118, United States
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Ann Arbor, Michigan, 48109, United States
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St Louis, Missouri, 63110, United States
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Albuquerque, New Mexico, 87106, United States
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New York, New York, 10029, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15213-1863, United States
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Houston, Texas, 77030, United States
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Seattle, Washington, 98109-1023, United States
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Vienna, 1090, Austria
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Bruxelles - Brussel, 1000, Belgium
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Sofia, 1527, Bulgaria
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Guangzhou, Guangdong, 510060, China
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Beijing, 100021, China
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Beijing, 100730, China
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Chengdu, 610041, China
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Hangzhou, 310022, China
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Shanghai, 200030, China
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Shanghai, 200127, China
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Tianjin, 300060, China
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Odense C, 5000, Denmark
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Angers, 49933, France
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Bordeaux, 33076, France
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Caen, 14076, France
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Lille, 59037, France
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Lyon, 69373, France
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Marseille, 13273, France
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Paris, 75651, France
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Villejuif, 94805, France
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Erlangen, Bavaria, 91054, Germany
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München, Bavaria, 81377, Germany
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Würzburg, Bavaria, 97080, Germany
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Cologne, North Rhine-Westphalia, 50924, Germany
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Essen, North Rhine-Westphalia, 45122, Germany
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Leipzig, Saxony, 04103, Germany
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Napoli, Campania, 80131, Italy
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Genoa, Liguria, 16132, Italy
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Milan, Lombardy, 20122, Italy
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Milan, Lombardy, 20133, Italy
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Milan, Lombardy, 20162, Italy
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Catania, Sicily, 95029, Italy
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Pisa, Tuscany, 56124, Italy
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Siena, Tuscany, 53100, Italy
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Perugia, Umbria, 06126, Italy
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Nagoya, Aichi-ken, 464-8681, Japan
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Nagoya, Aichi-ken, 466-8560, Japan
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Kashiwa, Chiba, 277-8577, Japan
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Koto-ku, Tokyo, 135-8550, Japan
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Groningen, 9713 GZ, Netherlands
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Leiden, 2333 ZA, Netherlands
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Gliwice, 44-101, Poland
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Poznan, 60-355, Poland
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Warsaw, 02-781, Poland
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Warsaw, 04-141, Poland
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Obninsk, 249036, Russia
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Riyadh, 11211, Saudi Arabia
Asan Medical Center
Seoul, Seoul Teugbyeolsi, 138-736, South Korea
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Daejeon, 301-721, South Korea
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 137-701, South Korea
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Majadahonda, Madrid, 28222, Spain
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Barcelona, 08035, Spain
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Gothenburg, 413 45, Sweden
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Linköping, 581 85, Sweden
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Lund, 221 85, Sweden
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Stockholm, 171 76, Sweden
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Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SM2 5PT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Sutton, SM2 5PT, United Kingdom
Related Publications (5)
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.
PMID: 26370187RESULTBrose 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.
PMID: 24768112RESULTBrose 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.
PMID: 21834960RESULTBrose 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.
PMID: 31558473DERIVEDCapdevila 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.
PMID: 31540966DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2009
First Posted
September 25, 2009
Study Start
October 15, 2009
Primary Completion
August 31, 2012
Study Completion
August 30, 2017
Last Updated
September 13, 2018
Results First Posted
December 10, 2013
Record last verified: 2018-08