Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

NCT04194086 | Completed Phase 1

• 1 other identifier: 2018-EKZX-003
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.

Conditions

Leukemia, Acute

Outcome Measures

Primary Outcomes (2)

• Number, type and grade of adverse events of posaconazole assessed by CTCAE v4.0

  Number, type and grade of adverse events of posaconazole oral suspensions to children with leukemia assessed by CTCAE v4.0.

  1 year

• Plasma posaconazole concentration monitoring and its pharmacokinetic

  Blood samples for determination of plasma posaconazole concentration will be collected predoses (just prior to a daily dose) on days 3, 7, 14 and 21. Anther concentration (include peak concentraton) will also be collected at least 7days after the first dose.

  1 year

Secondary Outcomes (1)

• Serious Adverse events and drug-related adverse events monitoring

  2 years

Study Arms (1)

posaconazole as antifungal prophylaxis

EXPERIMENTAL

Drug: posaconazole oral suspensions

Interventions

posaconazole oral suspensions DRUG

posaconazole oral suspensions（5mg/kg/d,tid) will be administered specially febrile neutropenia patients four times a day and blood samples will be taken any hours after the first dose at least Day 7.

posaconazole as antifungal prophylaxis

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 、Patients age 2-14 years with acute leukemia (AML, ALL) undergoing chemotherapy and neutropenia expected to last at least 7 days.
• 、Karnofsky/Lansky score of 60% or greater. 3、defined as alanine transaminase (ALT) \<3 x upper limit of normal (ULN),aspartate aminotransferase (AST) \<3 x ULN; serum bilirubin and alkaline phosphatase \<2 x ULN.
• 、No other treatment and combination of triazoles antifungals and drugs like vincristine, sirolimus, cyclosporine etc.
• 、Able to take oral medication or take medication via enteral feeding tube. 6、Ability to give informed consent. 7、No history of anaphylaxis attributed to the azole class of antifungal agents.

You may not qualify if:

• 、Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction.
• 、Subject is not considered eligible for this clinical research program with posaconazole.
• 、Use of medications that are known to interact with posaconazole and that may lead to life-threatening side to effects.

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Guangdong Provincial People's Hospital: collaborator

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, China

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: December 11, 2019
• Study Start: November 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 30, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)