Carcinoma, Hepatocellular Clinical Trial
Official title:
A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.
The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).
In addition to the key secondary outcome parameters the following parameters will be
assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic
progression (TTSP), response rate (RR) and overall survival between the 2 study populations.
The possible and potential predictive assays of clinical benefit through an assessment of
the correlation between the defined baseline characteristics and key clinical endpoints.
The safety and tolerability will be assessed in the adverse event section. Doxorubicin
pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and
the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e.,
cardiotoxicity).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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