Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499811
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2007-07-10
Brief Title:
Vorinostat in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma and Liver Dysfunction
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I and Pharmacokinetic Study of Vorinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction
Status:
COMPLETED
Status Verified Date:
2011-10
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 I trial is studying the side effects and best dose of vorinostat in treating patients with metastatic or unresectable solid tumors or lymphoma and liver dysfunction closed for accrual as of 04052010 Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Vorinostat may have different effects in patients who have changes in their liver function
Detailed Description:
PRIMARY OBJECTIVES
I Determine the pharmacokinetic disposition of vorinostat SAHA in patients with metastatic or unresectable solid tumors or lymphoma and varying degrees of hepatic dysfunction
II Establish the maximum tolerated dose MTD and dose-limiting toxicity DLT of vorinostat in groups of patients with varying degrees of hepatic dysfunction mild moderate or severe
SECONDARY OBJECTIVES
I Document the non-DLTs associated with administration of vorinostat in patients with hepatic dysfunction
II Determine the association of the Child-Pugh classification of hepatic dysfunction with the observed toxicities plasma pharmacokinetics and pharmacodynamics of vorinostat administration
III Document any antitumor activity associated with vorinostat treatment in patients enrolled on this study
OUTLINE This is a parallel-group dose-escalation study Patients are stratified according to level of hepatic dysfunction normal vs mild vs moderate vs severe closed for accrual as of 04052010
PART I Vorinostat SAHA will be administered as a single oral dose on day -6 for all patients Blood samples are obtained periodically on day -6 for pharmacokinetic studies
PART II One week later day 1 the first course of oral vorinostat will be initiated on a continuous daily oral regimen Each treatment course will consist of 21 days of therapy Treatment continues in the absence of disease progression or unacceptable toxicity
Dose escalation will proceed within each hepatic dysfunction group except in the normal group Only dose-limiting toxicities DLTs that occur during the first cycle of treatment will be used to guide dose escalation The maximum tolerated dose MTD is the highest dose at which no more than one instance of DLT is observed among 6 patients treated Once the MTD has been determined for a given hepatic dysfunction group a maximum of 12 patients will be accrued to this dose level
After completion of study treatment patients are followed for 4 weeks
I Determine the pharmacokinetic disposition of vorinostat SAHA in patients with metastatic or unresectable solid tumors or lymphoma and varying degrees of hepatic dysfunction
II Establish the maximum tolerated dose MTD and dose-limiting toxicity DLT of vorinostat in groups of patients with varying degrees of hepatic dysfunction mild moderate or severe
SECONDARY OBJECTIVES
I Document the non-DLTs associated with administration of vorinostat in patients with hepatic dysfunction
II Determine the association of the Child-Pugh classification of hepatic dysfunction with the observed toxicities plasma pharmacokinetics and pharmacodynamics of vorinostat administration
III Document any antitumor activity associated with vorinostat treatment in patients enrolled on this study
OUTLINE This is a parallel-group dose-escalation study Patients are stratified according to level of hepatic dysfunction normal vs mild vs moderate vs severe closed for accrual as of 04052010
PART I Vorinostat SAHA will be administered as a single oral dose on day -6 for all patients Blood samples are obtained periodically on day -6 for pharmacokinetic studies
PART II One week later day 1 the first course of oral vorinostat will be initiated on a continuous daily oral regimen Each treatment course will consist of 21 days of therapy Treatment continues in the absence of disease progression or unacceptable toxicity
Dose escalation will proceed within each hepatic dysfunction group except in the normal group Only dose-limiting toxicities DLTs that occur during the first cycle of treatment will be used to guide dose escalation The maximum tolerated dose MTD is the highest dose at which no more than one instance of DLT is observed among 6 patients treated Once the MTD has been determined for a given hepatic dysfunction group a maximum of 12 patients will be accrued to this dose level
After completion of study treatment patients are followed for 4 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 |
|---|---|---|---|
| NCI-2009-00272 | REGISTRY | None | None |
| NCI-07-C-0228 | None | None | None |
| CDR0000555102 | None | None | None |
| PCI-UPCI 07-013 | None | None | None |
| UPCI 07-013 | OTHER | None | None |
| 8057 | OTHER | None | None |
| N01CM62208 | NIH | None | None |
| U01CA099168 | NIH | None | None |
| U01CA062505 | NIH | None | None |
| U01CA062491 | NIH | None | None |
| U01CA062487 | NIH | None | None |
| P30CA047904 | NIH | CTEP | httpsreporternihgovquickSearchP30CA047904 |