A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma
This study was terminated on April 22th, 2010, based on a higher incidence of serious
adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that
sunitinib did not meet the criteria to demonstrate that it was either superior or
non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer.
Patients on sunitinib who are judged by the investigator as receiving clinical benefit may
chose to remain on study and continue treatment with sunitinib until clinical benefit as per
the investigator's judgment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival (OS)
Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
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United States: Food and Drug Administration
|Pfizer Investigational Site||Blendora, California 91740|
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