Spots Global Cancer Trial Database for Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
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Trial Identification
Brief Title: Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
Official Title: 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
Study ID: NCT00984282
Conditions
Study Description
Brief Summary: Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine
Detailed Description: Eligible subjects were randomized 1:1 to sorafenib 800 mg daily or matching placebo. Progression was assessed every 8 weeks by modified RECIST criteria. Subjects had the option to unblind study treatment after progression and to receive open label sorafenib regardless of initial treatment assignment. Following discontinuation of study treatment, subjects were followed for survival every 3 months in long-term follow-up. Subjects who terminated study treatment (either double only or double blind and open label) for reasons other than death, lost to follow-up or consent withdrawn entered long-term follow up
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, 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
, Saint 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
, Wien, , 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 cedex, , France
, Lyon, , France
, MARSEILLE cedex, , France
, Paris, , France
, Villejuif, , France
, Erlangen, Bayern, Germany
, München, Bayern, Germany
, Würzburg, Bayern, Germany
, Essen, Nordrhein-Westfalen, Germany
, Köln, Nordrhein-Westfalen, Germany
, Leipzig, Sachsen, Germany
, Napoli, Campania, Italy
, Genova, Liguria, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Catania, Sicilia, Italy
, Pisa, Toscana, Italy
, Siena, Toscana, Italy
, Perugia, Umbria, Italy
, Nagoya, Aichi, Japan
, Nagoya, Aichi, Japan
, Kashiwa, Chiba, Japan
, Koto-ku, Tokyo, Japan
Asan Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
, Daejeon, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Groningen, , Netherlands
, Leiden, , Netherlands
, Gliwice, , Poland
, Poznan, , Poland
, Warszawa, , Poland
, Warszawa, , Poland
, Obninsk, , Russian Federation
, Riyadh, , Saudi Arabia
, Majadahonda, Madrid, Spain
, Barcelona, , Spain
, Göteborg, , 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
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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