Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390052
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2006-10-18
Brief Title:
3-AP in Treating Patients With Advanced or Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I and Pharmacokinetic Study of Oral 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone3-APTriapine in the Treatment of Advanced Solid Tumors
Status:
COMPLETED
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 3-AP in treating patients with advanced or metastatic solid tumors 3-AP may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
OBJECTIVES
I Determine the safety tolerability and toxicity of oral 3-AP in patients with advanced solid tumors
II Determine the maximum tolerated dose and recommended phase II dose of this drug in these patients
III Determine the oral bioavailability and pharmacokinetics of this drug IV Assess tumoral expression of genes involved in response and resistance to 3-AP
V Observe and record any tumor response in these patients
OUTLINE This is a multicenter dose-escalation study
Patients receive a one time dose of 3-AP IV over 2 hours on day -7 Patients then receive oral 3-AP twice daily on days 1-3 8-10 and 15-17 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of oral 3-AP until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Blood samples for pharmacokinetic analysis are collected periodically over 8 hours after the IV dose of 3-AP and after the first oral dose of 3-AP during course 1
After completion of study treatment patients are followed periodically
I Determine the safety tolerability and toxicity of oral 3-AP in patients with advanced solid tumors
II Determine the maximum tolerated dose and recommended phase II dose of this drug in these patients
III Determine the oral bioavailability and pharmacokinetics of this drug IV Assess tumoral expression of genes involved in response and resistance to 3-AP
V Observe and record any tumor response in these patients
OUTLINE This is a multicenter dose-escalation study
Patients receive a one time dose of 3-AP IV over 2 hours on day -7 Patients then receive oral 3-AP twice daily on days 1-3 8-10 and 15-17 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of oral 3-AP until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Blood samples for pharmacokinetic analysis are collected periodically over 8 hours after the IV dose of 3-AP and after the first oral dose of 3-AP during course 1
After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| U01CA062505 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062505 |
| NCI-2009-00139 | REGISTRY | None | None |
| PHI-52 | None | None | None |
| CDR0000507731 | None | None | None |
| PHI-52 | OTHER | None | None |
| 7225 | OTHER | None | None |