Phase 2
N=137
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
Carcinoma, Hepatocellular
Bottom Line
View on ClinicalTrials.gov: NCT00044512 ↗Enrolled (actual)
137
Serious AEs
56.2%
Results posted
Aug 2009
Primary outcome: Primary: Percentage of Participants for Each Type of Response — 0; 2.2; 5.8; 54.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sorafenib (Nexavar, BAY43-9006) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants for Each Type of Response |
0; 2.2; 5.8; 54.7; 13.9; 22.6 | — |
| SECONDARY Duration of Response |
374 | — |
| SECONDARY Time to Response |
144 | — |
| SECONDARY Time to Progression |
167 | — |
| SECONDARY Duration of Stable Disease |
166 | — |
| SECONDARY Time to Minor Response |
84 | — |
| SECONDARY Duration of Minor Response |
122 | — |
| SECONDARY Overall Survival |
280 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Fibrolamellar disease mixed histology
- Metastatic brain or meningeal tumors
Data sourced from ClinicalTrials.gov (NCT00044512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.