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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Multi kinase inhibitor plus Chemotherapy
Chemotherapy plus Placebo
Unnamed facility
Birmingham, Alabama, United States
Time to Progression (TTP)
TTP was defined as the time from randomization to radiological disease progression by independent assessment.
Time frame: from date of randomization of the first patient until 3 years later
Overall Survival
The time from date of randomization to date of death
Time frame: from date of randomization of the first patient until 3 years later
Progression Free Survival (PFS)
Time from the date of randomization to the date of the first documented radiological progression (as defined per independent central radiological assessment) or death, whichever occurs first
Time frame: from date of randomization of the first patient until 3 years later
Percentage of Participants in Each Category of Best Tumor Response
Percentage of participants with complete or partial response (CR or PR) confirmed according to Response Evaluation Criteria in Solid Tumors (RECIST) and achieved during treatment or 30 days after end of treatment. CR: disappearance of all clinical and radiological tumor lesions. PR: at least 30% decrease in sum of the longest diameters of tumor lesions. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.
Time frame: achieved during treatment or within 30 days after termination of active therapy
Time to Symptomatic Progression (TTSP)
Time from date of randomization to date of first documented symptomatic progression defined by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index-8 (FHSI-8) assessment
Time frame: from date of randomization of the first patient until 3 years later
Duration of Response
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Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Orange, California, United States
Unnamed facility
Palo Alto, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Sylmar, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Lafayette, Louisiana, United States
Unnamed facility
Minneapolis, Minnesota, United States
...and 18 more locations
Time from date of first objective response (complete response \[CR\] or partial response \[PR\]) to date progression is first documented (as defined per independent central radiological assessment) or death, whichever occurs first
Time frame: from date of randomization of the first patient until 3 years later
Time to Response (TTR)
Time from date of randomization to date of first objective response (complete response \[CR\] or partial response \[PR\]) is documented and confirmed according to RECIST criteria
Time frame: from date of randomization until 3 years later at end of study
Percentage of Participants for Whom Disease Control Was Achieved
Participants with disease control: those who have as best response complete response (CR), partial response (PR) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease) according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: from date of randomization to end of treatment plus 30 days