Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042900
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2002-08-05
Brief Title:
Pyroxamide in Treating Patients With Advanced Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Clinical And Pharmacological Study Of Pyroxamide NSC 696085 In Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2013-06
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 pyroxamide in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies
Define qualitatively and quantitatively the dose-limiting and non-dose-limiting toxic effects of this drug in these patients
Describe the pharmacologic behavior of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive pyroxamide IV continuously over 5-7 days Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of pyroxamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for resolution of adverse events
PROJECTED ACCRUAL A maximum of 32 patients will be accrued for this study
Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies
Define qualitatively and quantitatively the dose-limiting and non-dose-limiting toxic effects of this drug in these patients
Describe the pharmacologic behavior of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive pyroxamide IV continuously over 5-7 days Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of pyroxamide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for resolution of adverse events
PROJECTED ACCRUAL A maximum of 32 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-2110 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069483 | REGISTRY | None | None |