Liver Cancer Clinical Trial
Official title:
Phase I Study of Combination of Sorafenib and LBH589 in Hepatocellular Carcinoma
RATIONALE: Panobinostat and sorafenib may stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth. Sorafenib may also stop the growth of liver cancer by
blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when
given together with sorafenib in treating patients with liver cancer that is metastatic
and/or cannot be removed by surgery.
OBJECTIVES:
Primary
- Assess the safety and tolerability of panobinostat when combined with standard doses of
sorafenib tosylate in patients with metastatic and/or unresectable hepatocellular
carcinoma.
- Determine the maximum tolerated dose of panobinostat when combined with standard doses
of sorafenib tosylate in these patients.
Secondary
- Determine the response rate.
- Determine the progression-free survival.
- Determine the overall survival rate.
OUTLINE: This is a dose escalation study of panobinostat.
Patients receive panobinostat IV on days 1 and 8 and oral sorafenib tosylate twice daily on
days 1-21. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study therapy, patients are followed for 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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