Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093613
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2004-10-06
Brief Title:
Sorafenib in Treating Patients With Recurrent or Progressive Malignant Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of BAY 43-9006 for Patients With Recurrent or Progressive Malignant Glioma
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:
This phase I trial is studying the side effects and best dose of sorafenib in treating patients with recurrent or progressive malignant glioma Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of BAY 43-9006 when administered to adults with recurrent malignant glioma receiving Group A or not receiving Group B anticonvulsants known to be metabolized by the P450 hepatic enzyme complex
II To assess and estimate the dose-related toxicities III To describe the pharmacokinetics of this route of administration measuring BAY 43-9006 and to assess the pharmacokinetic difference between patients taking enzyme-inducing agents and those who are not
IV To estimate overall survival
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to the concurrent use of cytochrome P450-inducing anticonvulsants yes vs no
Patients receive oral sorafenib twice daily on days 1-28 once daily on day 1 of course 1 only Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients per stratum receive escalating doses of sorafenib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity
Patients are followed every 2 months
I To determine the maximum tolerated dose MTD of BAY 43-9006 when administered to adults with recurrent malignant glioma receiving Group A or not receiving Group B anticonvulsants known to be metabolized by the P450 hepatic enzyme complex
II To assess and estimate the dose-related toxicities III To describe the pharmacokinetics of this route of administration measuring BAY 43-9006 and to assess the pharmacokinetic difference between patients taking enzyme-inducing agents and those who are not
IV To estimate overall survival
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to the concurrent use of cytochrome P450-inducing anticonvulsants yes vs no
Patients receive oral sorafenib twice daily on days 1-28 once daily on day 1 of course 1 only Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients per stratum receive escalating doses of sorafenib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity
Patients are followed every 2 months
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-2012-03102 | REGISTRY | None | None |
| NABTT-0401 | None | None | None |
| ABTC-0401 | None | None | None |
| NABTT 0401 | OTHER | None | None |
| NABTT-0401 | OTHER | None | None |
| U01CA062475 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062475 |