NCT00984282

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 417 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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(either double only or double blind and open label) for reasons other than death, lost to follow-up or consent withdrawn entered long-term follow up

Conditions

• Thyroid Neoplasms

Interventions

Type	Name	Description
DRUG	Sorafenib (Nexavar, BAY43-9006)	Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
DRUG	Placebo	Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).

Timeline

• Start date: 2009-10-15
• Primary completion: 2012-08-31
• Completion: 2017-08-30
• First posted: 2009-09-25
• Last updated: 2018-09-13
• Results posted: 2013-12-10

Locations

81 sites across 18 countries: United States, Austria, Belgium, Bulgaria, China, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Russia, Saudi Arabia, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study