Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: A Phase 0 Clinical T… (NCT04825275) | Clinical Trial Compass
TerminatedEarly Phase 1
Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: A Phase 0 Clinical Trial
Stopped: The study was stopped due to slow accrual.
United States7 participantsStarted 2022-05-13
Plain-language summary
This research is being done to find out if the study drug (posaconazole) can enter brain tumors at a high enough amount to stop the tumor cells from dividing. Posaconazole is a drug which doctors already use for fungal infections and is thought to be able to effect tumor cells. As treatments for this type of brain tumor are limited, it is hoped that the results of this study will help to determine if the study drug should be studied further as a possible treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Evidence of primary or recurrent HGG that in the opinion of the treating team would require surgical resection
* Karnofsky Performance Score (KPS) ≥ 60%
* ECOG ≤ 2
* Life expectancy greater than 12 weeks
* Adequate liver function defined as ALT, AST, ALP within 1.5x institutional upper limit of normal (for study drug arm only)
* Ability to swallow medication (for study drug arm only)
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation (for study drug arm only)
* Ability to understand and willingness to sign a written informed consent document
* Be able to comply with treatment plan, study procedures and follow-up examinations
Exclusion Criteria:
* Patients may not be receiving any other investigational agents while on study
* Patients who have known allergy to posaconazole or other azoles (for study drug arm only)
* Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous azole class drugs for a parasitic infection (for study drug arm only)
* Patients with a history of acute or chronic hepatitis (for study drug arm only)
* Patients with liver enzymes (ALT, AST, ALP) \>1.5x above normal range for the laboratory performing the test (for study drug arm only)
* Patients who are taking metronidazole and cannot be safely moved to a different antib…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Posaconazole Concentration in Cerebrospinal Fluid Using Microdialysis Catheters
Timeframe: Collected over a 24-hour period after surgery (biopsy or resection)