At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 417 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006) +1 moredrug
Likely dose
Sorafenib (Nexavar, BAY43-9006) 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) and Placebo for Thyroid Neoplasms. Completed, enrolled 417 participants across 81 sites in 18 countries.
Detailed Summary
Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Neoplasms
CountriesAustria, Belgium, Bulgaria, China, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Russia, Saudi Arabia, South Korea, Spain, Sweden, United Kingdom, United States
CollaboratorsAmgen
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2009
Enrollment StartOct 2009
Primary CompletionAug 2012
Study CompletionAug 2017
TodayJul 2026
First PostedSep 25, 2009
Enrollment StartOct 15, 2009
Primary CompletionAug 31, 2012
Study CompletionAug 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.8 years ago
Interventions
Sorafenib (Nexavar, BAY43-9006)drug
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
Placebodrug
Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).