Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

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.