Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369200
Status:
TERMINATED
Last Update Posted:
2013-12-11
First Post:
2006-08-24
Brief Title:
AFP464 in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Study of AFP464 Aminoflavone Prodrug in Patients With Advanced Solid Tumors
Status:
TERMINATED
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 AFP464 in treating patients with advanced solid tumors Drugs used in chemotherapy such as AFP464 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I Determine the dose-limiting toxicity and maximum tolerated dose of AFP464 in patients with advanced solid tumors
II Assess the safety and tolerability of this drug in these patients
SECONDARY OBJECTIVES
I Observe clinical response in patients treated with this drug II Characterize the pharmacokinetics of this drug in these patients III Determine the clinical significance of genetic polymorphisms on the genes coding metabolizing enzymes eg CYP1A1 1A2 2C9 2C19 and SULTA1 and on the disposition and efficacytoxicity of AFP464 and AF
OUTLINE This a dose-escalation multicenter study
Patients receive AFP464 IV over 3 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Cohorts of 2-6 patients receive escalating doses of AFP464 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 1 of 6 patients experience dose-limiting toxicity An additional 10 patients whose tumor is amenable to biopsy are treated at the MTD
Patients undergo blood collection periodically for pharmacokinetic and pharmacodynamic studies Patients treated at the MTD also undergo tumor tissue biopsies periodically for additional pharmacodynamic and correlative biomarker studies
After completion of study treatment patients are followed for 4 weeks
I Determine the dose-limiting toxicity and maximum tolerated dose of AFP464 in patients with advanced solid tumors
II Assess the safety and tolerability of this drug in these patients
SECONDARY OBJECTIVES
I Observe clinical response in patients treated with this drug II Characterize the pharmacokinetics of this drug in these patients III Determine the clinical significance of genetic polymorphisms on the genes coding metabolizing enzymes eg CYP1A1 1A2 2C9 2C19 and SULTA1 and on the disposition and efficacytoxicity of AFP464 and AF
OUTLINE This a dose-escalation multicenter study
Patients receive AFP464 IV over 3 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Cohorts of 2-6 patients receive escalating doses of AFP464 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 1 of 6 patients experience dose-limiting toxicity An additional 10 patients whose tumor is amenable to biopsy are treated at the MTD
Patients undergo blood collection periodically for pharmacokinetic and pharmacodynamic studies Patients treated at the MTD also undergo tumor tissue biopsies periodically for additional pharmacodynamic and correlative biomarker studies
After completion of study treatment patients are followed for 4 weeks
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 |
|---|---|---|---|
| U01CA062487 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062487 |
| NCI-2009-00163 | REGISTRY | None | None |
| CDR0000492006 | None | None | None |
| 2006-011 | OTHER | None | None |
| 7378 | OTHER | None | None |