Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010205
Status:
TERMINATED
Last Update Posted:
2013-01-25
First Post:
2001-02-02
Brief Title:
Benzoylphenylurea in Treating Patients With Advanced Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial Of Benzoylphenylurea NSC639829 In Advanced Malignancy
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
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 benzoylphenylurea in treating patients with advanced cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the dose-limiting toxicity and the maximum tolerated dose of benzoylphenylurea in patients with advanced malignancy
II Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive oral benzoylphenylurea weekly for 6 weeks Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of benzoylphenylurea until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study
I Determine the dose-limiting toxicity and the maximum tolerated dose of benzoylphenylurea in patients with advanced malignancy
II Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive oral benzoylphenylurea weekly for 6 weeks Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of benzoylphenylurea until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 3-30 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 |
|---|---|---|---|
| CDR0000068455 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA069854 |
| UMGCC 0038 | None | None | None |
| U01CA069854 | NIH | None | None |