Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

Phase 1

Completed

• Conditions: Pediatric, Cancer
• Interventions: Drug: Itraconazole

• Registration Number: NCT01409018
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-12
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Study Completion: 2011-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-17
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Itraconazole	Itraconazole	-

Primary Outcome Measures

Name	Time	Method
To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients	28 days	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 Outcome Measures

Name	Time	Method
To assess empirical antifungal efficacy and safety in pediatric cancer patients	28 days	1. Efficacy evaluation : Treatment is considered successful if all five of the following criteria are met : treatment of baseline fungal infection, absence of breakthrough fungal infection, survival for 7 days after completion, resolution of fever (\<38°C for 48hrs) in neutropenia, and no premature discontinuation because of drug related toxicity or lack of efficacy.; 2. Safety evaluation : Laboratory are performed at the time of enrollment, twice weekly during therapy, and 1 week after the end of therapy. Drug-related toxicity was graded according to the NCI Common Toxicity Criteria (v4.0).

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Chongno-gu, Korea, Republic of