NCT00390052

3-AP in Treating Patients With Advanced or Metastatic Solid Tumors

A Phase I and Pharmacokinetic Study of Oral 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone(3-AP,Triapine) in the Treatment of Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	triapine	Given IV and orally
OTHER	pharmacological study	correlative study
PROCEDURE	laboratory biomarker analysis	Correlative study

Timeline

• Start date: 2006-12-01
• Primary completion: 2011-02-01
• First posted: 2006-10-19
• Last updated: 2013-12-16

Locations

1 site across 1 country: United States