Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321594
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2006-05-02
Brief Title:
Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of PXD101 in Patients With Unresectable Hepatocellular Carcinoma With Pharmacokinetic and Pharmacodynamic Evaluation
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial is studying the side effects and best dose of belinostat and to see how well it works in treating patients with liver cancer that cannot be removed by surgery Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the dose-limiting toxicity DLT and establish the maximum tolerated dose MTD of PXD101 belinostat in patients with unresectable hepatocellular carcinoma HCC Phase I II Assess the pharmacokinetic profiles of PXD101 in these patients Phase I III Assess tumor response in patients treated with this drug Phase II
OUTLINE This is a multicenter dose-escalation phase I study followed by a phase II study
PHASE I Patients receive belinostat intravenously IV over 30 minutes on days 1-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of belinostat until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PHASE II Patients receive belinostat as in phase I at the MTD determined in phase I
After completion of study therapy patients are followed for up to 8 weeks
I Determine the dose-limiting toxicity DLT and establish the maximum tolerated dose MTD of PXD101 belinostat in patients with unresectable hepatocellular carcinoma HCC Phase I II Assess the pharmacokinetic profiles of PXD101 in these patients Phase I III Assess tumor response in patients treated with this drug Phase II
OUTLINE This is a multicenter dose-escalation phase I study followed by a phase II study
PHASE I Patients receive belinostat intravenously IV over 30 minutes on days 1-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of belinostat until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PHASE II Patients receive belinostat as in phase I at the MTD determined in phase I
After completion of study therapy patients are followed for up to 8 weeks
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000463519 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62205 |
| CTRG-HC062105 | None | None | None |
| N01CM62205 | NIH | None | None |