Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants

NCT03717623 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2017.105
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the pharmacokinetics of oral dosage of Posaconazole which is routinely administered as a standard care prophylaxis for patients undergoing cancer treatments.

Conditions

Posaconazole; Pharmacokinetics; Invasive Candidiases; Invasive Aspergillosis; Invasive Mycosis; Fungal Infection; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Pre-dose plasma Posaconazole concentrations

  The median interquartile range pre-dose plasma Posaconazole concentrations equal or greater than 0.7 mg/L will be assessed.

  On days 7, 14 and 21 of Posaconazole prophylaxis course, when significant diarrhea occurs, when active gastrointestinal graft versus host disease occurs.

Secondary Outcomes (4)

• Clinical symptoms affecting plasma Posaconazole concentrations.

  At Screening, Days 7, 14 and 21, and 72 hours after onset of diarrhoea, and when invasive fungal infection occurs.

• The number/proportion of patients achieving desirable pre-dose plasma Posaconazole concentrations.

  On days 7, 14 and 21 of Posaconazole prophylaxis course, when significant diarrhea occurs, when active gastrointestinal graft versus host disease occurs.

• Effects of diarrhea on plasma Posaconazole concentration

  When diarrhea occurs during Posaconazole prophylaxis on Days 1 to 21.

• Alteration in prophylaxis due to Posaconazole-attributed toxicities.

  When change in or cessation of oral Posaconazole prophylaxis occurs during Day 1 to Day 21.

Study Arms (1)

Posaconazole prophylaxis

EXPERIMENTAL

Blood samples will be taken from participants undergoing cancer treatment and receiving Posaconazole prophylaxis. The samples will be used for Posaconazole pharmacokinetics study.

Drug: Posaconazole pharmacokinetics

Interventions

Posaconazole pharmacokinetics DRUG

Blood samples will be collected on Days 7, 14 and 21 from the onset of Posaconazole prophylactic treatment If significant diarrhoea occurs, additional blood samples will be collected twice weekly until symptoms resolve. All blood samples will be used for Posaconazole pharmacokinetics study.

Also known as: Blood sampling

Posaconazole prophylaxis

Eligibility Criteria

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

You may qualify if:

• Adult (≥18 years old) haematology patients receiving Posaconazole prophylaxis in the inpatient setting as standard of care.
• Able to give informed consent.

You may not qualify if:

• Unable to give informed consent.

Sponsors & Collaborators

• Melbourne Health: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Melbourne Health

Parkville, Victoria, 3050, Australia

RECRUITING

MeSH Terms

Conditions

Candidiasis, Invasive; Invasive Fungal Infections; Mycoses

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Candidiasis; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Monica Slavin, Prof

CONTACT

61 3 9342 9403; monica.slavin@mh.org.au

Tseng Lau, PhD

CONTACT

61 3 9342 8274; tseng.lau@mh.org.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 24, 2018
• Study Start: August 1, 2019
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

AU (1)