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NCT Number: NCT01409018

Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

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.

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Key information

Conditions

Pediatric, Cancer Bacterial Infections and Mycoses Infections Invasive Fungal Infections Mycoses Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients who are under chemotherapy, and receive itraconazole.

Exclusion criteria

  • 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.

Treatment and study plan

Itraconazole

Drug

pharmacokinetics

Other names: Itraconazole(spranox)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 3, 2011
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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