Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025415
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2001-10-11
Brief Title:
Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have advanced cancer and liver dysfunction
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with advanced malignancies and varying degrees of liver dysfunction
II Determine the effects of hepatic dysfunction on the pharmacodynamics and pharmacokinetics of this drug in these patients
III Determine the non-dose-limiting toxic effects of this drug in these patients
IV Determine the response rate of these patients treated with this drug V Correlate the Childs-Pugh classification of hepatic dysfunction with observed toxic effects pharmacodynamics and pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to liver dysfunction normal vs mild vs moderate vs severe
Patients receive oral imatinib mesylate daily Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients within each stratum except normal stratum receive escalating doses of imatinib mesylate 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
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 1 year
I Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with advanced malignancies and varying degrees of liver dysfunction
II Determine the effects of hepatic dysfunction on the pharmacodynamics and pharmacokinetics of this drug in these patients
III Determine the non-dose-limiting toxic effects of this drug in these patients
IV Determine the response rate of these patients treated with this drug V Correlate the Childs-Pugh classification of hepatic dysfunction with observed toxic effects pharmacodynamics and pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to liver dysfunction normal vs mild vs moderate vs severe
Patients receive oral imatinib mesylate daily Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients within each stratum except normal stratum receive escalating doses of imatinib mesylate 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
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000068959 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062487 |
| 01-028 | None | None | None |
| U01CA099168 | NIH | None | None |
| U01CA062505 | NIH | None | None |
| U01CA062491 | NIH | None | None |
| U01CA062502 | NIH | None | None |
| U01CA062487 | NIH | None | None |