Clinical trial · Interventional
Pharmacokinetics of Itraconazole in Pediatric Cancer Patients
NCT01409018CI-TRIAL-00012688completedPhase 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 study investigated repeated-dose pharmacokinetics and safety of itraconazole and its active metabolite hydroxyitraconazole in pediatric cancer patients at risk for the development of invasive fungal disease.
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 |
|---|---|---|---|
| Pediatric, Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Itraconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Itraconazole
- interventionNames
- Drug: Itraconazole
Primary outcomes (1)
- measure
- To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients
- timeFrame
- 28 days
- description
- 1. Itraconazole administration 1) Oral for prophylaxis: 2mg/kg/dose,q12hr 2) IV for empirical therapy : After more than 2 days of oral prophylaxis, patients with persistent neutropenic fever / Induction : 5 mg/kg/dose, q12hr X 4 doses / Maintenance : 5 mg/kg/dose,q24hr 2. Sampling 1) During oral : prior to the 5th dose 2) During IV : prior to the every induction and 1-5th maintenance doses, and 1, 2, 4, 8, 12, 24hr after the 3rd IV maintenance 3. Analysis of drug concentrations : Plasma concentrations of itraconazole and hydroxyl-itraconazole are measured using HPLC.
Secondary outcomes (1)
- measure
- To assess empirical antifungal efficacy and safety in pediatric cancer patients
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Pediatric patients who are under chemotherapy, and receive itraconazole. Exclusion Criteria: 1. Patients with significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. * Heart : fractional shortening \< 30%, ejection fraction \< 45% * Liver : total bilirubin ≥ 2 x upper limit of normal (ULN) ; aminotransferase ≥ 3 x ULN * Kidney : creatinine ≥ 2 x normal or GFR ≤ 60㎖/min/1.73㎡ 2. Patients with hypersensitivity to azoles. 3. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. 4. Pregnant or nursing women. 5. Psychiatric disorder that would preclude compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.