Clinical trial · Interventional
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
NCT00390052CI-TRIAL-00012996completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Procedure | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| triapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: triapine
- Other: pharmacological study
- Procedure: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Maximum tolerated dose of oral 3-AP determined by dose-limiting toxicities graded according to the NCI CTCAE version 3.0
- timeFrame
- 28 days
Secondary outcomes (1)
- measure
- Serum pharmacokinetics of oral triapine
- timeFrame
- Baseline, day 4, and day 8
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Criteria: * Must be able to swallow * Histologically confirmed solid tumor * Advanced or metastatic disease * Measurable or evaluable disease * No known active CNS metastases * ECOG performance status 0-1 * Life expectancy \> 3 months * Progressive disease during \>= 1 prior standard therapy OR disease unlikely to respond to any currently available therapies * Patients with previously treated CNS metastases who have no evidence of new CNS metastases AND are stable for \>= 2 months are eligible * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 10 g/dL (transfusions allowed) * Absolute neutrophil count \>= 1,500/mm\^3 * ALT and AST =\< 2.5 times upper limit of normal (ULN) * Alkaline phosphatase =\< 2.5 times ULN * Creatinine =\< 1.5 mg/dL OR creatinine clearance \>= 50 mL/min * Bilirubin normal * PT/PTT =\< 1.5 times ULN * FEV1 \>= 1.2 L * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception 2 weeks prior to and during study treatment * No mental deficits and/or psychiatric history that may preclude study treatment * No active heart disease, including any of the following: myocardial infarction within the past 3 months, symptomatic coronary artery disease or heart block, uncontrolled congestive heart failure * No moderate to severe compromise of pulmonary function * No active infection * No other life-threatening illness * No active coagulation disorder other than occult blood * No known positivity for glucose-6-phosphate dehydrogenase (G6PD) deficiency * Recovered from prior treatment * Prior gemcitabine allowed * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * More than 3 weeks since prior radiotherapy or any other treatment for this cancer * No prior 3-AP * No concurrent radiotherapy * No other concurrent investigational agent
References
Publications (0)
Data not yet available
No reference posted for this study.