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Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

Phase 1
Not Enrolling
Pediatric, Cancer

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Trial Information

Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients

Outcome Description:

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 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 Analysis of drug concentrations : Plasma concentrations of itraconazole and hydroxyl-itraconazole are measured using HPLC.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Hyoung Jin Kang, M.D, ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


Korea: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

December 2011

Related Keywords:

  • Pediatric, Cancer
  • pediatric
  • cancer
  • invasive fungal disease
  • antifungal agent