NCT00873002

Panobinostat and Sorafenib in Treating Patients With Liver Cancer That is Metastatic and/or Cannot Be Removed by Surgery

Phase I Study of Combination of Sorafenib and LBH589 in Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	panobinostat	Dose escalation: 7.5 mg/m2 day 1 and day 8 of 21 days cycle 10 mg/m2 day 1 and day 8 of 21 days cycle 15 mg/m2 day 1 and day 8 of 21 days cycle 20 mg/m2 day 1 and day 8 of 21 days cycle 30 mg/m2 day 1 and day 8 of 21 days cycle
DRUG	sorafenib tosylate	400 mg PO BID

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2009-04-01
• Last updated: 2012-03-20

Locations

1 site across 1 country: United States