Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054483
Status:
COMPLETED
Last Update Posted:
2013-05-16
First Post:
2003-02-05
Brief Title:
Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Pharmacokinetic Study of PS341 in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group
Status:
COMPLETED
Status Verified Date:
2013-05
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 study the effectiveness of bortezomib in treating patients who have advanced cancer and kidney dysfunction Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To identify the pharmacokinetic and pharmacodynamic profile of PS-341 in patients with advanced malignancy and mild moderate or severe renal insufficiency
II Evaluate the safety tolerability and the maximum tolerated dose of PS-341 for patients with varying degrees of renal insufficiency
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to most recent creatinine clearance greater than 60 mLmin vs 40-59 mLmin vs 20-39 mLmin vs less than 20 mLmin vs any creatinine clearance and undergoing renal dialysis
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional cohort of up to 12 patients is treated at the MTD
PROJECTED ACCRUAL A total of 60-69 patients at least 12 per stratum will be accrued for this study
I To identify the pharmacokinetic and pharmacodynamic profile of PS-341 in patients with advanced malignancy and mild moderate or severe renal insufficiency
II Evaluate the safety tolerability and the maximum tolerated dose of PS-341 for patients with varying degrees of renal insufficiency
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to most recent creatinine clearance greater than 60 mLmin vs 40-59 mLmin vs 20-39 mLmin vs less than 20 mLmin vs any creatinine clearance and undergoing renal dialysis
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional cohort of up to 12 patients is treated at the MTD
PROJECTED ACCRUAL A total of 60-69 patients at least 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 |
| CO 02903 | None | None | None |
| CDR0000270687 | None | None | None |
| U01CA062491 | NIH | None | None |
| U01CA069852 | NIH | None | None |
| U01CA062505 | NIH | None | None |
| U01CA062487 | NIH | None | None |
| U01CA069853 | NIH | None | None |
| U01CA062502 | NIH | None | None |