3-AP in Treating Patients With Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00390052|
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : December 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: triapine Other: pharmacological study Procedure: laboratory biomarker analysis||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I and Pharmacokinetic Study of Oral 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone(3-AP,Triapine) in the Treatment of Advanced Solid Tumors|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||February 2011|
Experimental: Arm I
Patients will receive a 2-hour infusion of 3-AP once in week 1. Beginning in week 2, they will receive 3-AP by mouth twice a day 3 days a week for 3 weeks. Treatment with 3-AP by mouth may repeat every 4 weeks for as long as benefit is shown.
Given IV and orally
Other Names:Other: pharmacological study
Other Name: pharmacological studiesProcedure: laboratory biomarker analysis
- Maximum tolerated dose of oral 3-AP determined by dose-limiting toxicities graded according to the NCI CTCAE version 3.0 [ Time Frame: 28 days ]
- Serum pharmacokinetics of oral triapine [ Time Frame: Baseline, day 4, and day 8 ]Summary statistics of the pharmacokinetic parameters will be tabulated using the logarithmic scale where appropriate. The relationship of the AUC to the dose will be assessed by least-square regression analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390052
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||Yun Yen||City of Hope Medical Center|