Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017524
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2001-06-06
Brief Title:
AG2037 in Treating Patients With Advanced Metastatic or Recurrent Solid Tumors
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Phase I Dose-Escalation Study of AG2037 Administered Once Weekly for Three Weeks to Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2012-11
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 tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of AG2037 in treating patients who have advanced metastatic or recurrent solid tumors
PURPOSE Phase I trial to study the effectiveness of AG2037 in treating patients who have advanced metastatic or recurrent solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxic effects of AG2037 in patients with advanced metastatic or recurrent solid tumor
Determine the safety and tolerance of this drug in these patients
Assess the pharmacokinetics of this drug in these patients
Document any antitumor effects of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive AG2037 IV weekly on weeks 1-3 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of AG2037 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
Patients are followed weekly for 4 weeks
PROJECTED ACCRUAL A total of 18-60 patients will be accrued for this study
Determine the maximum tolerated dose and dose-limiting toxic effects of AG2037 in patients with advanced metastatic or recurrent solid tumor
Determine the safety and tolerance of this drug in these patients
Assess the pharmacokinetics of this drug in these patients
Document any antitumor effects of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive AG2037 IV weekly on weeks 1-3 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of AG2037 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
Patients are followed weekly for 4 weeks
PROJECTED ACCRUAL A total of 18-60 patients 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 |
|---|---|---|---|
| NCI-G01-1954 | None | None | None |
| UAB-0052 | None | None | None |
| AG-2037-003-A2 | None | None | None |
| UAB-F001227008 | None | None | None |