Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091117
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2004-09-07
Brief Title:
Bortezomib 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 PS-341 in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction for the CTEPSponsored Organ Dysfunction Working Group
Status:
COMPLETED
Status Verified Date:
2013-12
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:
Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth This phase I trial is studying the side effects and best dose of bortezomib in treating patients with advanced cancer and liver dysfunction
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of bortezomib in patients with advanced malignancies and varying degrees of liver dysfunction
II Determine the safety and tolerability of this drug in these patients III Determine the pharmacokinetics and pharmacodynamics of this drug in these patients with mild moderate or severe liver insufficiency
IV Examine the dietary influences on bortezomib disposition and efficacy V Examine the influences of proteasome inhibition on CYP 450 activity
OUTLINE This is a multicenter dose-escalation study Patients are stratified according to hepatic function normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction
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 per stratum receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Note Patients with normal hepatic function do not receive escalating doses of bortezomib
I Determine the maximum tolerated dose of bortezomib in patients with advanced malignancies and varying degrees of liver dysfunction
II Determine the safety and tolerability of this drug in these patients III Determine the pharmacokinetics and pharmacodynamics of this drug in these patients with mild moderate or severe liver insufficiency
IV Examine the dietary influences on bortezomib disposition and efficacy V Examine the influences of proteasome inhibition on CYP 450 activity
OUTLINE This is a multicenter dose-escalation study Patients are stratified according to hepatic function normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction
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 per stratum receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Note Patients with normal hepatic function do not receive escalating doses of bortezomib
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 |
|---|---|---|---|
| U01CA070095 | NIH | CTEP | httpsreporternihgovquickSearchU01CA070095 |
| NCI-2009-00059 | REGISTRY | None | None |
| CDR0000383782 | None | None | None |
| C-2802 | None | None | None |
| 6432 | OTHER | None | None |
| C-2802 | OTHER | None | None |
| U01CA062487 | NIH | None | None |
| U01CA062505 | NIH | None | None |
| U01CA069853 | NIH | None | None |
| U01CA062491 | NIH | None | None |