Trial Condition(s):

Thyroid Neoplasms

Nexavar® versus Placebo in locally advanced/metastatic RAI-Refractory Differentiated Thyroid Cancer

Bayer Identifier:

14295

ClinicalTrials.gov Identifier:

NCT00984282

EudraCT Number:

2009-012007-25

Study Completed

Trial Purpose

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
417
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Erlangen, Germany, 91054

Status
Completed
 
Locations

Investigative Site

Essen, Germany, 45122

Status
Completed
 
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Investigative Site

Leeds, United Kingdom, LS9 7TF

Status
Completed
 
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Investigative Site

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
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Cardiff, United Kingdom, CF14 2TL

Status
Completed
 
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Investigative Site

Boston, United States, 02118

Status
Completed
 
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Houston, United States, 77030

Status
Completed
 
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Investigative Site

New Haven, United States, 06520

Status
Completed
 
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Investigative Site

Pittsburgh, United States, 15213-1863

Status
Completed
 
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Investigative Site

Ann Arbor, United States, 48109

Status
Completed
 
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Los Angeles, United States, 90048

Status
Completed
 
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Investigative Site

Würzburg, Germany, 97080

Status
Completed
 
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Investigative Site

London, United Kingdom, SM2 5PT

Status
Completed
 
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London, United Kingdom, SE1 9RT

Status
Completed
 
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Manchester, United Kingdom, M20 4BX

Status
Completed
 
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Investigative Site

St. Louis, United States, 63110

Status
Completed
 
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Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
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Investigative Site

Seattle, United States, 98109-1023

Status
Completed
 
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Stanford, United States, 94305-5820

Status
Completed
 
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Albuquerque, United States, 87106

Status
Completed
 
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Investigative Site

Atlanta, United States, 30322

Status
Completed
 
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Investigative Site

BORDEAUX, France, 33076

Status
Completed
 
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Investigative Site

VILLEJUIF, France, 94805

Status
Completed
 
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LYON, France, 69373

Status
Completed
 
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PARIS, France, 75651

Status
Completed
 
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Poznan, Poland, 60-355

Status
Completed
 
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Siena, Italy, 53100

Status
Completed
 
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Milano, Italy, 20162

Status
Completed
 
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Perugia, Italy, 06126

Status
Completed
 
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Catania, Italy, 95029

Status
Completed
 
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Milano, Italy, 20122

Status
Completed
 
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Barcelona, Spain, 08035

Status
Completed
 
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Leiden, Netherlands, 2333 ZA

Status
Completed
 
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Göteborg, Sweden, 413 45

Status
Completed
 
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CAEN, France, 14076

Status
Completed
 
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MARSEILLE cedex, France, 13273

Status
Completed
 
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Investigative Site

ANGERS, France, 49933

Status
Completed
 
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Investigative Site

LILLE cedex, France, 59037

Status
Completed
 
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Investigative Site

Warszawa, Poland, 04-141

Status
Completed
 
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Investigative Site

Warszawa, Poland, 02-781

Status
Completed
 
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Gliwice, Poland, 44-101

Status
Completed
 
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Kashiwa, Japan, 277-8577

Status
Completed
 
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Nagoya, Japan, 464-8681

Status
Completed
 
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Investigative Site

Koto-ku, Japan, 135-8550

Status
Completed
 
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Nagoya, Japan, 466-8560

Status
Completed
 
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Pisa, Italy, 56124

Status
Completed
 
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Napoli, Italy, 80131

Status
Completed
 
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Majadahonda, Spain, 28222

Status
Completed
 
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Groningen, Netherlands, 9713 GZ

Status
Completed
 
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Investigative Site

Lund, Sweden, 221 85

Status
Completed
 
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Investigative Site

Odense C, Denmark, 5000

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
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Investigative Site

Seoul, South Korea, 135-710

Status
Completed
 
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Investigative Site

Seoul, South Korea, 120-752

Status
Completed
 
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Seoul, South Korea, 110-744

Status
Completed
 
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Investigative Site

Riyadh, Saudi Arabia, 11211

Status
Completed
 
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Investigative Site

Linköping, Sweden, 581 85

Status
Completed
 
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Investigative Site

Stockholm, Sweden, 171 76

Status
Completed
 
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Investigative Site

Seoul, South Korea, 137-701

Status
Completed
 
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Investigative Site

Daejeon, South Korea, 301-721

Status
Completed
 
Locations

Investigative Site

München, Germany, 81377

Status
Completed
 
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Investigative Site

Köln, Germany, 50924

Status
Completed
 
Locations

Investigative Site

Leipzig, Germany, 04103

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
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Investigative Site

Wien, Austria, 1090

Status
Completed
 
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Investigative Site

Shanghai, China, 200030

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510060

Status
Completed
 
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Investigative Site

Beijing, China, 100730

Status
Completed
 
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Investigative Site

Beijing, China, 100021

Status
Completed
 
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Investigative Site

Tianjin, China, 300060

Status
Completed
 
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Investigative Site

chengdu, China, 610041

Status
Completed
 
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Investigative Site

hangzhou, China, 310022

Status
Completed
 
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Investigative Site

shanghai, China, 200127

Status
Completed
 
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Investigative Site

Obninsk, Russia, 249036

Status
Completed
 
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Investigative Site

Milano, Italy, 20133

Status
Completed
 
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Investigative Site

Sutton, United Kingdom, SM2 5PT

Status
Completed
 
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Investigative Site

Aberdeen, United Kingdom, AB25 2ZN

Status
Completed
 
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Investigative Site

Glasgow, United Kingdom, G12 0YN

Status
Completed
 
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Investigative Site

Genova, Italy, 16132

Status
Completed
 
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Investigative Site

Sofia, Bulgaria, 1527

Status
Completed
 
Locations

Investigative Site

New York, United States, 10029

Status
Completed
 

Trial Design