Pharmacokinetics of Itraconazole in Pediatric Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01409018|
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : November 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pediatric, Cancer||Drug: Itraconazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of Itraconazole in Pediatric Cancer Patients|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2011|
Other Name: Itraconazole(spranox)
- To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients [ Time Frame: 28 days ]
- 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.
- To assess empirical antifungal efficacy and safety in pediatric cancer patients [ Time Frame: 28 days ]
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409018
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Chongno-gu, Korea, Republic of|
|Principal Investigator:||Hyoung Jin Kang, M.D, ph.D||Seoul National University Hospital|