Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00348699
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2006-07-05
Brief Title:
AFP464 in Treating Patients With Metastatic or Refractory Solid Tumors That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study and Pharmacological Trial of Once Weekly Aminoflavone Prodrug AFP464 Administered 3 Out of Every 4 Weeks in Solid Tumor Patients
Status:
COMPLETED
Status Verified Date:
2011-12
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 studies the side effects and best dose of AFP464 in treating patients with metastatic or refractory solid tumors that cannot be removed by surgery 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 maximum tolerated dose MTD of AFP464 in patients with advanced solid tumors
II Evaluate the toxicity profile of AFP464 III Characterize the plasma pharmacokinetics and urinary excretion of AFP464 and aminoflavone in these patients
IV Identify any activity of AFP464 in patients with metastatic cancer V Explore whether AFP464 induces cytochrome p450 family 1 member A1 CYP1A1 expression in tumor patients enrolled at the MTD patients enrolled at the MTD andor circulating tumor cells CTCs dose-escalation phase and at the MTD
VI To explore the relationship between the pharmacogenetic analysis and toxicity or response
OUTLINE This is a dose-escalation study
Patients receive AFP464 intravenously IV over 3 hours on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for up to 3 months
I Determine the maximum tolerated dose MTD of AFP464 in patients with advanced solid tumors
II Evaluate the toxicity profile of AFP464 III Characterize the plasma pharmacokinetics and urinary excretion of AFP464 and aminoflavone in these patients
IV Identify any activity of AFP464 in patients with metastatic cancer V Explore whether AFP464 induces cytochrome p450 family 1 member A1 CYP1A1 expression in tumor patients enrolled at the MTD patients enrolled at the MTD andor circulating tumor cells CTCs dose-escalation phase and at the MTD
VI To explore the relationship between the pharmacogenetic analysis and toxicity or response
OUTLINE This is a dose-escalation study
Patients receive AFP464 intravenously IV over 3 hours on days 1 8 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for up to 3 months
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 |
|---|---|---|---|
| U01CA069912 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069912 |
| NCI-2009-00164 | REGISTRY | None | None |
| MAYO-IAB-05-00404800 | None | None | None |
| MAYO-IAB-05-00404801 | None | None | None |
| NCI-7380 | None | None | None |
| CDR0000476275 | None | None | None |
| MAYO-MC0513 | None | None | None |
| MC0513 | OTHER | None | None |
| 7380 | OTHER | None | None |
| P30CA015083 | NIH | None | None |