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: February 27, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2011

Last Updated Date

February 27, 2013

Start Date ^ICMJE

June 2009

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

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.

Original Primary Outcome Measures ^ICMJE

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 ]

Itraconazole administration 1) Oral for prophylaxis: 2mg/kg/dose,q12hr 2) IV for empirical therapy : After more than 3 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.

Change History

Complete list of historical versions of study NCT01409018 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess empirical antifungal efficacy and safety in pediatric cancer patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

Official Title ^ICMJE

Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pediatric, Cancer

Intervention ^ICMJE

Drug: Itraconazole

pharmacokinetics

Other Name: Itraconazole(spranox)

Study Arm (s)

Experimental: Itraconazole

Intervention: Drug: Itraconazole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2011

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01409018

Other Study ID Numbers ^ICMJE

SNUCH-R-0804

Has Data Monitoring Committee

Yes

Responsible Party

Oncology team, Janssen Korea Ltd.

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hyoung Jin Kang, M.D, ph.D

Seoul National University Hospital

Information Provided By

Seoul National University Hospital

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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