Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026169
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2001-11-09
Brief Title:
Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure
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 Degrees of Renal Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to determine the dose of imatinib mesylate that is most effective with the least amount of toxic side effects in treating patients who have advanced cancer and kidney failure Imatinib mesylate may stop the growth of cancer cells by stopping the enzyme necessary for cancer cell growth Kidney failure may delay the elimination of imatinib mesylate from the body which may lead to longer drug exposure and increase toxic side effects
Detailed Description:
PRIMARY OBJECTIVES
I To establish the maximum tolerated dose MTD of STI571 for cohorts of patients with varying degrees of renal dysfunction normal mild moderate and severe
II To determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of STI571
III To evaluate the safety of STI571 in patients with various degrees of renal dysfunction
OUTLINE This is a dose-escalation study Patients are stratified according to creatinine clearance at least 60 mLmin vs 40-59 mLmin vs 20-39 mLmin vs less than 20 mLmin vs any creatinine clearance and undergoing dialysis
Patients receive oral imatinib mesylate once or twice daily on days 1 and 4-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in each 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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 60-69 patients about 12 per stratum will be accrued for this study
I To establish the maximum tolerated dose MTD of STI571 for cohorts of patients with varying degrees of renal dysfunction normal mild moderate and severe
II To determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of STI571
III To evaluate the safety of STI571 in patients with various degrees of renal dysfunction
OUTLINE This is a dose-escalation study Patients are stratified according to creatinine clearance at least 60 mLmin vs 40-59 mLmin vs 20-39 mLmin vs less than 20 mLmin vs any creatinine clearance and undergoing dialysis
Patients receive oral imatinib mesylate once or twice daily on days 1 and 4-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in each 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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 60-69 patients about 12 per stratum will be accrued for this study
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 |
|---|---|---|---|
| U01CA099168 | NIH | None | httpsreporternihgovquickSearchU01CA099168 |
| CWRU 1Y01 | None | None | None |
| U01CA062487 | NIH | None | None |
| U01CA062505 | NIH | None | None |
| U01CA069853 | NIH | None | None |
| U01CA062502 | NIH | None | None |
| U01CA062491 | NIH | None | None |