Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017264
Status:
COMPLETED
Last Update Posted:
2009-01-13
First Post:
2001-06-06
Brief Title:
Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2004-08
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of atrasentan in treating patients who have progressive or recurrent malignant glioma
PURPOSE Phase I trial to study the effectiveness of atrasentan in treating patients who have progressive or recurrent malignant glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of atrasentan in patients with progressive or recurrent malignant glioma
Describe the pharmacokinetics of this drug in these patients
Assess preliminary evidence of therapeutic activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral atrasentan once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 2-10 patients receive escalating doses of atrasentan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 1 patient experiences dose-limiting toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL Approximately 35 patients will be accrued for this study
Determine the maximum tolerated dose of atrasentan in patients with progressive or recurrent malignant glioma
Describe the pharmacokinetics of this drug in these patients
Assess preliminary evidence of therapeutic activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral atrasentan once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 2-10 patients receive escalating doses of atrasentan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 1 patient experiences dose-limiting toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL Approximately 35 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHOC-NABTT-2008 | None | None | None |
| NABTT-2008 | None | None | None |