Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT00873002
Status:
TERMINATED
Last Update Posted:
2012-03-20
First Post:
2009-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Panobinostat and Sorafenib in Treating Patients With Liver Cancer That is Metastatic and/or Cannot Be Removed by Surgery
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Phase I Study of Combination of Sorafenib and LBH589 in Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Dose Limiting Toxicity
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |
| CASE6208 | OTHER | Case Comprehensive Cancer Center | View | |
| CLBH589BUS23T | None | None | View |