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Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01409018
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : November 19, 2013
Information provided by:
Seoul National University Hospital

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 fungal disease.

Condition or disease Intervention/treatment Phase
Pediatric, Cancer Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Itraconazole Drug: Itraconazole
Other Name: Itraconazole(spranox)

Primary Outcome Measures :
  1. To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients [ Time Frame: 28 days ]
    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 :
  1. To assess empirical antifungal efficacy and safety in pediatric cancer patients [ Time Frame: 28 days ]
    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).

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01409018

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

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Responsible Party: Oncology team, Janssen Korea Ltd. Identifier: NCT01409018     History of Changes
Other Study ID Numbers: SNUCH-R-0804
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013
Keywords provided by Seoul National University Hospital:
invasive fungal disease
antifungal agent
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors