The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.
The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,035
Site Reference ID/Investigator# 23247
Beverly Hills, California, United States
Site Reference ID/Investigator# 23608
LaVerne, California, United States
Site Reference ID/Investigator# 23852
Orange, California, United States
Site Reference ID/Investigator# 40162
Orange, California, United States
Site Reference ID/Investigator# 23254
Newark, Delaware, United States
Overall Survival
Time frame: From randomization until patient death; assessed monthly
Time To Progression (TTP)
Time frame: From randomization until patient progression; assessed every 6 weeks
Overall Response Rate (ORR)
Time frame: Assessed Every 6 weeks
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Site Reference ID/Investigator# 23253
Gainesville, Georgia, United States
Site Reference ID/Investigator# 23609
Honolulu, Hawaii, United States
Site Reference ID/Investigator# 24848
Honolulu, Hawaii, United States
Site Reference ID/Investigator# 23250
Louisville, Kentucky, United States
Site Reference ID/Investigator# 23257
St Louis, Missouri, United States
...and 153 more locations