A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- Registration Number
- NCT00044512
- Lead Sponsor
- Bayer
- Brief Summary
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.
- Detailed Description
In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:
* Pharmacokinetics (PK) profile of Sorafenib
* Plasma and tissue tumor biomarkers
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
- Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
- Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
- Measurable disease
- At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI)
- Presence of at least 1 of the following:
- Alpha-fetoprotein greater than the upper limit of normal (ULN)
- Hepatitis C antibody positive
- Hepatitis B surface antigen positive
- Child's Pugh class A or B
- Candidate for systemic therapy
- Fibrolamellar disease mixed histology
- Metastatic brain or meningeal tumors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sorafenib 400 mg b.i.d. Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
- Primary Outcome Measures
Name Time Method Percentage of Participants for Each Type of Response Until 30 days after termination of active therapy Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.
- Secondary Outcome Measures
Name Time Method Duration of Response up to 3 years later Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.
Time to Response up to 3 years later Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).
Time to Progression up to 3 years later Time from the first date of receiving study drug until the first documented PD.
Duration of Stable Disease up to 3 years later Time from the first day of receiving study drug until there was a documented PD or response.
Time to Minor Response up to 3 years later Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = \>25% regression.
Duration of Minor Response Time from MR to PD Time from the date that MR was first documented to the date that PD was first documented.
Overall Survival Start of treatment to death Time from the first date of receiving study medication to death.