Status:
COMPLETED
Pharmacokinetics of Itraconazole in Pediatric Cancer Patients
Lead Sponsor:
Seoul National University Hospital
Conditions:
Pediatric, Cancer
Eligibility:
All Genders
Phase:
PHASE1
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 fun...
Eligibility Criteria
Inclusion
- Pediatric patients who are under chemotherapy, and receive itraconazole.
Exclusion
- 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㎡
- Patients with hypersensitivity to azoles.
- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- Pregnant or nursing women.
- Psychiatric disorder that would preclude compliance.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01409018
Start Date
June 1 2009
End Date
December 1 2011
Last Update
November 19 2013
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Chongno-gu, South Korea