A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.
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.,
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Time to Progression (TTP)
TTP was defined as the time from randomization to radiological disease progression by independent assessment.
from date of randomization of the first patient until 3 years later
Bayer Study Director
United States: Food and Drug Administration
|Alexandria, Minnesota 56308|
|Birmingham, Alabama 35294|
|Fountain Valley, California 92708|
|Miami, Florida 33176|
|Albany, New York 12208|
|Nashville, Tennessee 37203-1632|
|Seattle, Washington 98195|
|Hackensack, New Jersey 07601|
|Metairie, Louisiana 70006|