Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants (POPULAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717623
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : August 27, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Melbourne Health

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.

Condition or disease Intervention/treatment Phase
Posaconazole Pharmacokinetics Invasive Candidiases Invasive Aspergillosis Invasive Mycosis Fungal Infection Prophylaxis Drug: Posaconazole pharmacokinetics Phase 4

Detailed Description:

Participants receiving Posaconazole prophylaxis for invasive fungal infection while undergoing cancer treatment will be required to sign an informed consent and donate blood samples for the study. Posaconazole is routinely administered as a prophylaxis using the oral tablet formulation (300mg once daily) as a standard care. Each prophylaxis course-duration will be defined according to local policy at each hospital. In general, Posaconazole prophylaxis commences prior to or with induction or consolidation chemotherapy in AML/MDS patients and continues until neutrophil recovery. In allo-HSCT setting, Posaconazole prophylaxis routinely commences on the day of transplant or with conditioning chemotherapy and continues for approximately 3 months after transplant, except in patients with initiation of intensive immunosuppression after diagnosis of acute or chronic GVHD, administration will go for at least 16 weeks or until prednisolone dose is less than 10mg per day, whichever is later. If patients are suspected or have proven malabsorption or are required to switch to an alternative antifungal agent such as in the case of suspected invasive fungal infection or Posaconazole toxicity, a switch to intravenous formulation of Posaconazole will take place.

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, with the first sample being taken 3 days after the onset of diarrhoea. If gastrointestinal absorption is considered inadequate or invasive fungal infection is suspected and patients are switched either to IV antifungal prophylaxis or antifungal treatment as part of their standard care, a blood sample will be collected 20-24 hours after the last oral Posaconazole dose. Study participants will be followed up with respect to clinical data collection during the blood sample collection period and for up to 7 days after the last dose of Posaconazole for invasive fungal infection follow-up, and for the entire antifungal prescribing period (prophylaxis and/or treatment). Participants with diagnosed invasive fungal infection will be followed up to 30-days post-diagnosis with respect to clinical outcomes.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics Study of Posaconazole in Haematology Patients Receiving Standard of Care Treatment With Oral Posaconazole Prophylaxis for Invasive Fungal Infection
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Posaconazole prophylaxis
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
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.
Other Name: Blood sampling




Primary Outcome Measures :
  1. Pre-dose plasma Posaconazole concentrations [ Time Frame: On days 7, 14 and 21 of Posaconazole prophylaxis course, when significant diarrhea occurs, when active gastrointestinal graft versus host disease occurs. ]
    The median interquartile range pre-dose plasma Posaconazole concentrations equal or greater than 0.7 mg/L will be assessed.


Secondary Outcome Measures :
  1. Clinical symptoms affecting plasma Posaconazole concentrations. [ Time Frame: At Screening, Days 7, 14 and 21, and 72 hours after onset of diarrhoea, and when invasive fungal infection occurs. ]
    Observed association between concurrent patient factors with change in plasma Posaconazole concentrations.

  2. The number/proportion of patients achieving desirable pre-dose plasma Posaconazole concentrations. [ Time Frame: On days 7, 14 and 21 of Posaconazole prophylaxis course, when significant diarrhea occurs, when active gastrointestinal graft versus host disease occurs. ]
    The number/proportion of patients achieving pre-dose plasma Posaconazole concentrations greater or equal to 0.7 mg/L will be assessed.

  3. Effects of diarrhea on plasma Posaconazole concentration [ Time Frame: When diarrhea occurs during Posaconazole prophylaxis on Days 1 to 21. ]
    Correlation between the presence/extent of diarrhea with change in plasma Posaconazole concentrations.

  4. Alteration in prophylaxis due to Posaconazole-attributed toxicities. [ Time Frame: When change in or cessation of oral Posaconazole prophylaxis occurs during Day 1 to Day 21. ]
    Frequency of Posaconazole-attributed toxicities resulting in dose changes or cessation of prophylaxis will be noted.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717623


Contacts
Layout table for location contacts
Contact: Monica Slavin, Prof 61 3 9342 9403 monica.slavin@mh.org.au
Contact: Tseng Lau, PhD 61 3 9342 8274 tseng.lau@mh.org.au

Locations
Layout table for location information
Australia, Victoria
Melbourne Health Recruiting
Parkville, Victoria, Australia, 3050
Contact: Tseng Lau, PhD         
Sponsors and Collaborators
Melbourne Health
Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT03717623     History of Changes
Other Study ID Numbers: 2017.105
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Mycoses
Candidiasis
Aspergillosis
Candidiasis, Invasive
Invasive Fungal Infections
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs