Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01409018
First received: July 8, 2011
Last updated: November 17, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Pediatric, Cancer
Drug: Itraconazole
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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:
  • To assess empirical antifungal efficacy and safety in pediatric cancer patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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).


Enrollment: 6
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Itraconazole Drug: Itraconazole
pharmacokinetics
Other Name: Itraconazole(spranox)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01409018

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Chongno-gu, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hyoung Jin Kang, M.D, ph.D Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Oncology team, Janssen Korea Ltd.
ClinicalTrials.gov Identifier: NCT01409018     History of Changes
Other Study ID Numbers: SNUCH-R-0804
Study First Received: July 8, 2011
Last Updated: November 17, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
pediatric
cancer
invasive fungal disease
antifungal agent

Additional relevant MeSH terms:
Itraconazole
Hydroxyitraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014