MedDataX Logo

Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

NCT ID: NCT01409018

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric, Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pediatric cancer invasive fungal disease antifungal agent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Itraconazole

Group Type EXPERIMENTAL

Itraconazole

Intervention Type DRUG

pharmacokinetics

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Itraconazole

pharmacokinetics

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Itraconazole(spranox)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Janssen Korea Ltd.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyoung Jin Kang, M.D, ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SNUCH-R-0804

Identifier Type: -

Identifier Source: org_study_id