Phase I Study of Combination of Sorafenib and LBH589 in Hepatocellular Carcinoma
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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of Safety and Tolerability
•Primary objective of the phase I trial will be to assess the safety and tolerability and to determine the maximum tolerated dose (MTD) of LBH 589 when combined with standard doses of sorafenib in the treatment of hepatocellular carcinoma.
6months to 1 year
Yes
Richard Kim, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
CASE6208
NCT00873002
March 2009
June 2010
Name | Location |
---|---|
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |