DECISION: Study Design
• Locally advanced or
metastatic, RAI-refractory
DTC
• Progression (RECIST) within
the previous 14 months
• No prior chemotherapy,
targeted therapy, or
thalidomide
417 patients
randomized
from November 2009 to
August 2011
•
Stratified by:
–
Geographical region (North America or Europe or Asia)
–
Age (<60 or ≥60 years)
• Progression assessed by independent central review
every 8 weeks
• At progression
– Patients on placebo allowed to cross over at the investigator’s discretion
– Patients on sorafenib allowed to continue on open-label sorafenib at the investigator’s discretion
Sorafenib
400 mg orally twice daily
Placebo
Orally twice daily
Randomization 1:1
Primary endpoint
Secondary endpoints
•
Overall survival
•
Response rate
•
Safety
•
Time to progression
•
Disease control rate
•
Duration of response
•
Sorafenib exposure (AUC
0-12
)
• Progression-free survival
Brose M, et al. Lancet 2014
