Hepatocellular Cancer Clinical Trial
Official title:
Phase I Open-Label, Dose-Finding Study of BAY 43-9006 (Sorafenib) in High-risk Hepatocellular Cancer Patients After Liver Transplantation
This Phase I study of sorafenib in high risk hepatocellular cancer patients after liver transplantation will study 24 subjects for about 5 years. Each subject will receive sorafenib for 6 months. Safety and effectiveness on the post transplant, high risk HCC patients will be studied.
Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor with effects on tumor
proliferation and angiogenesis. Sorafenib is approved for the treatment of patients with
advanced renal cancer and unresectable hepatocellular carcinoma (HCC). The recommended daily
dose of Sorafenib is 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1
hour before or 2 hours after a meal). Studies of single-agent sorafenib showed treatment was
well-tolerated with manageable side effects. The results seen with sorafenib in the Phase
III (SHARP) trial suggest that VEGF and RAF kinase inhibition prolong survival in patients
with advanced HCC. It is not known whether a drug which is considered primarily cytostatic
will be effective in preventing cancer recurrences in the setting of minimal residual
disease.
This is a phase I, single center, open-label, dose-escalation study to determine the maximum
tolerated dose (MTD) and overall safety profile of daily sorafenib as therapy to prevent HCC
recurrence in liver transplant subjects with high-risk HCC. For each subject, the study will
consist of two phases: a treatment phase and an extension phase.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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