Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT00873002
Brief 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.
Study:
NCT00873002
Study Brief:
Protocol Section:
NCT00873002