Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

NCT01409018 | Completed Phase 1 DMC

• 1 other identifier: SNUCH-R-0804
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric, Cancer

Keywords

pediatric; cancer; invasive fungal disease; antifungal agent

Outcome Measures

Primary Outcomes (1)

• To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients

  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.

  28 days

Secondary Outcomes (1)

• To assess empirical antifungal efficacy and safety in pediatric cancer patients

  28 days

Study Arms (1)

Itraconazole

EXPERIMENTAL

Drug: Itraconazole

Interventions

Itraconazole DRUG

pharmacokinetics

Also known as: Itraconazole(spranox)

Itraconazole

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Location

MeSH Terms

Conditions

Neoplasms; Invasive Fungal Infections

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Hyoung Jin Kang, M.D, ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: August 3, 2011
• Study Start: June 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

KR (1)