A Phase 1 interventional study of Itraconazole in Pediatric, Cancer, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2013-11-19.
Sponsored by Seoul National University Hospital · Phase 1, Interventional, and Treatment
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Patients with significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.
Drug: Itraconazole
pharmacokinetics
Also known as: Itraconazole(spranox)
To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients
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.
Time frame: 28 days
To assess empirical antifungal efficacy and safety in pediatric cancer patients
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).
Time frame: 28 days
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital