Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Pediatric, Cancer

Treatments: Drug: Itraconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01409018

SNUCH-R-0804

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Itraconazole

Experimental group

Treatment:

Drug: Itraconazole