GlioblastomaEarly Phase 1NCT04825275
Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: A Phase 0 Clinical Trial
A Early Phase 1 study testing Posaconazole Pill in people with Glioblastoma and Glioblastoma Multiforme, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme of Brain
- What is being tested?
- Posaconazole Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2022to 6 Nov 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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 antibiotic greater than 7 days prior to starting posaconazole therapy (for study drug arm only)
Show all 17Show fewer
- Patients who are taking any anti-convulsant medication that interferes with the cytochrome P450 pathway (e.g. phenytoin, phenobarbital, carbamazepine, etc.) and who cannot be switched to alternative medications such as keppra (levetiracetam) (for study drug arm only)
- Uncontrolled intercurrent illness such as chronic hepatitis, acute hepatitis, or psychiatric illness/social situation that would limit compliance with study requirements (for study drug arm only)
- Patients with a history of Addison's disease or other forms of adrenal insufficiency (for study drug arm only)
- Patient with little or no stomach acid production (achlorhydria) (for study drug arm only)
- Pregnant and breast feeding women)
- Patients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the results.
- Patients who are not available for follow-up assessments or unable to comply with study requirements.
- Patients who are currently taking medications that induce the metabolism of posaconazole, such as isoniazid, nevirapine, rifamycins (such as rifabutin, rifampin), or St. John's wort and cannot be safely discontinued off of them for the duration of the trial (for study drug arm only).
- Patients who are currently taking medications for which the metabolism may be affected by posaconazole, which include but are not limited to: benzodiazepines (such as alprazolam, midazolam, triazolam), domperidone, eletriptan, eplerenone, ergot drugs (such as ergotamine), nisoldipine, drugs used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), some drugs used to treat seizures (such as carbamazepine, phenytoin), some statin drugs (such as atorvastatin, lovastatin, simvastatin) (for study drug arm only).
- Patients who are non-English speakers
- Patients who are not capable of understanding the consent form and would need a legally authorized representative.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the detailed description
Both ketoconazole and posaconazole are FDA-approved anti-fungal agents with a well-established side effect and safety profile. Ketoconazole and posaconazole have shown efficacy in reducing tumor cell proliferation in in-vitro studies. Furthermore, both have also shown efficacy, mediated at least in part through inhibition of HK2 activity, in animal models with dosing concentration and schedules that are documented as safe in humans. As a drug, posaconazole has a more predictable half-life than ketoconazole and has less off-target effects. Therefore, the proposed trial will focus on the role of posaconazole exclusively. As a first step, demonstration of adequate penetrance of study drug in brain and tumor tissue (pharmacokinetics) and biological effect (inhibition of glycolysis and subsequent tumor cell death) is necessary prior to large scale clinical studies. A total of 5 control participants will be included in this study as the investigator specifically wants to assess for pharmacodynamic differences too. The addition of a control group to this study rather to both the studies (ketoconazole study is a separate protocol) is because the investigator feels posaconazole may be a more promising drug for moving forward.
Plasma drug concentration measurements are an unreliable method to assess delivery of drugs across the blood-brain barrier. In contrast, intracerebral MDC monitoring allows for approximate measurements within extracellular fluid (ECF) sampling of the brain. MDC placement within the brain is not a novel technique and has been utilized routinely in the ICU setting to measure brain metabolism by sampling of ECF of traumatic brain injury patients [59-61].
MDC are now FDA-approved and are being placed routinely with intracranial pressure monitors. This method allows for continuous measurement of ECF within a tumor or normal tissue. The dialysis probe has a semipermeable membrane which is less than 1 mm in diameter into which two sections of microcatheter are fused. Previous studies have demonstrated the feasibility of keeping the catheters in place of critically injured patients for up to 2 weeks [62-64].
When placed at the time of surgical resection, the microcatheters are stereotactically implanted, placing the probe within the desired brain and/or tumor region. Externally, the catheter is connected to a syringe pump, which delivers a low flow rate (μl/min) of continuous perfusion fluid (Lactated Ringers or artificial CSF) and dialysate is collected in a microvial from the outlet tube. This sterile, single use catheter is minimally invasive and developed to achieve optimal diffusing characteristics similar to passive diffusion of a capillary blood vessel. Just as in the function of brain capillary vessel, water, inorganic ions and small organic molecules freely diffuse across the membrane of the probe, whereas proteins and protein bound compounds are impermeable. Additionally, lipophilic compounds are poorly recovered. Therefore, assessment of pharmacokinetics of drug using MDC provides valuable insight relevant to its anti-neoplastic properties.
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme of Brain, Glioblastoma Multiforme, Adult
- Being tested
- Posaconazole Pill
- Keywords
- Glioblastoma, Glioblastoma Multiforme, GBM, Brain cancer, Posaconazole, Anti-fungal agents
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posaconazole PillDrug
Also called Noxafil
300 mg (three 100 mg tablets) orally
| Study group | Role | What they receive |
|---|---|---|
| Posaconazole | Experimental | Participants will be taking 300 mg of the study drug (three 100 mg tablets) by mouth twice a day the first day and then 300 mg once a day until the day of biopsy or surgery. On the day of biopsy or surgery, participants will take their medication the morning of their biopsy or surgery (before the operation). Participants will then take the last dose of the medication in the morning of the day after their biopsy or surgery. Participants will be given 12 days' worth of the study drug (pills) and verbally instructed how and when to take them. Receives: Drug: Posaconazole Pill |
| Control | No intervention | Participants will not undergo any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posaconazole Concentration in Cerebrospinal Fluid Using Microdialysis Catheters
Assessment of the concentration of drug in the dialysate fluid.
Measured: Collected over a 24-hour period after surgery (biopsy or resection)
Secondary outcomes (7)
Number of Participants Able to Tolerate Preoperative Steady-state Dosing of Posaconazole
Measured through the Grade and Frequency of adverse events, based on the CTCAE v5.0 criteria
Measured: from Baseline to Visit 7 (14 days +/- 7 days post-op)
Posaconazole Effect on Hexokinase 2 Concentration Within Tumor Tissue
Measured using a hexokinase-2 ELISA with a range of 1.56 ng/mL - 100 ng/mL on tumor tissue.
Measured: Within 24 hours after biopsy or tumor resection
Posaconazole Effect on Tumor Proliferation in Tumor Tissue
Measured using Ki-67 proliferation index with of a range of 0% proliferation (no proliferation) to 100% (high proliferation). Ki-67 is a marker found in actively dividing cells. A higher Ki-67 value may signify a more aggressive tumor. Ki-67 is routinely measured during pathology analysis of tumor samples.
Measured: Within 24 hours after biopsy or tumor resection
Posaconazole Effect on Cell Death in Tumor Tissue
Measured using a BCL-2 ELISA with a range of 0.156 ng/mL to 10 ng/mL.
Measured: Within 24 hours after biopsy or tumor resection
Posaconazole Effect on Angiogenesis in Tumor Tissue
Measured using a CD31 ELISA with a range of 31.2 pg/mL to 2000 pg/mL.
Measured: Within 24 hours after biopsy or tumor resection
Correlation of Neuro-pharmacokinetic Profile of Posaconazole With Lactate Concentration
The concentration vs. time profile of posaconazole will be correlated with the concentration vs. time profile of lactate in the cerebrospinal fluid.
Measured: Collected over a 24-hour period after surgery (biopsy or resection)
Correlation of Neuro-pharmacokinetic Profile of Posaconazole With Pyruvate Concentration
The concentration vs. time profile of posaconazole will be correlated with the concentration vs. time profile of pyruvate in the cerebrospinal fluid.
Measured: Collected over a 24-hour period after surgery (biopsy or resection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start13 May 2022
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Why it stopped: The study was stopped due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alireza Mansouri, Penn State Health Milton S Hershey Medical Center
- Investigators
- Alireza Mansouri, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825275
- Sponsor's protocol ID
- STUDY00015948
- Other IDs
- 1R03CA255992-01
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2021
- Last updated
- 23 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mansouri A, de Macedo Filho L, Tufano E, Laukhuff H, Zacharia B, Neighbors J, Green M, Derosia N, Sun D, Bhanja D, Tuohy K, Connor J, Aregawi DG, Glantz M, Zadeh G. A phase 0 clinical trial to evaluate the neuropharmacological profile of posaconazole for glioblastoma. Neurooncol Adv. 2026 Jul 2;8(1):vdag174. doi: 10.1093/noajnl/vdag174. eCollection 2026 Jan-Dec.
PubMed 42494994Bhanja D, Neighbors J, Connor J, Zadeh G, Mansouri A. Neuropharmacological Study of Posaconazole for Glioblastoma: A Phase 0 Clinical Trial Protocol. Neurosurgery. 2022 Oct 1;91(4):658-665. doi: 10.1227/neu.0000000000002071. Epub 2022 Jul 25.
PubMed 35861778
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: A Phase 0 Clinical Trial
- ClinicalTrials.gov ID
- NCT04825275
- Acronym / sponsor ID
- STUDY00015948
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme of Brain, Glioblastoma Multiforme, Adult
- Keywords
- Glioblastoma, Glioblastoma Multiforme, GBM, Brain cancer, Posaconazole, Anti-fungal agents
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to slow accrual.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 May 2022 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Both ketoconazole and posaconazole are FDA-approved anti-fungal agents with a well-established side effect and safety profile. Ketoconazole and posaconazole have shown efficacy in reducing tumor cell proliferation in in-vitro studies. Furthermore, both have also shown efficacy, mediated at least in part through inhibition of HK2 activity, in animal models with dosing concentration and schedules that are documented as safe in humans. As a drug, posaconazole has a more predictable half-life than ketoconazole and has less off-target effects. Therefore, the proposed trial will focus on the role of posaconazole exclusively. As a first step, demonstration of adequate penetrance of study drug in brain and tumor tissue (pharmacokinetics) and biological effect (inhibition of glycolysis and subsequent tumor cell death) is necessary prior to large scale clinical studies. A total of 5 control participants will be included in this study as the investigator specifically wants to assess for pharmacodynamic differences too. The addition of a control group to this study rather to both the studies (ketoconazole study is a separate protocol) is because the investigator feels posaconazole may be a more promising drug for moving forward.
Plasma drug concentration measurements are an unreliable method to assess delivery of drugs across the blood-brain barrier. In contrast, intracerebral MDC monitoring allows for approximate measurements within extracellular fluid (ECF) sampling of the brain. MDC placement within the brain is not a novel technique and has been utilized routinely in the ICU setting to measure brain metabolism by sampling of ECF of traumatic brain injury patients [59-61].
MDC are now FDA-approved and are being placed routinely with intracranial pressure monitors. This method allows for continuous measurement of ECF within a tumor or normal tissue. The dialysis probe has a semipermeable membrane which is less than 1 mm in diameter into which two sections of microcatheter are fused. Previous studies have demonstrated the feasibility of keeping the catheters in place of critically injured patients for up to 2 weeks [62-64].
When placed at the time of surgical resection, the microcatheters are stereotactically implanted, placing the probe within the desired brain and/or tumor region. Externally, the catheter is connected to a syringe pump, which delivers a low flow rate (μl/min) of continuous perfusion fluid (Lactated Ringers or artificial CSF) and dialysate is collected in a microvial from the outlet tube. This sterile, single use catheter is minimally invasive and developed to achieve optimal diffusing characteristics similar to passive diffusion of a capillary blood vessel. Just as in the function of brain capillary vessel, water, inorganic ions and small organic molecules freely diffuse across the membrane of the probe, whereas proteins and protein bound compounds are impermeable. Additionally, lipophilic compounds are poorly recovered. Therefore, assessment of pharmacokinetics of drug using MDC provides valuable insight relevant to its anti-neoplastic properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posaconazole | Experimental | Drug: Posaconazole PillParticipants will be taking 300 mg of the study drug (three 100 mg tablets) by mouth twice a day the first day and then 300 mg once a day until the day of biopsy or surgery. On the day of biopsy or surgery, participants will take their medication the morning of their biopsy or surgery (before the operation). Participants will then take the last dose of the medication in the morning of the day after their biopsy or surgery. Participants will be given 12 days' worth of the study drug (pills) and verbally instructed how and when to take them. |
| Control | No intervention | –Participants will not undergo any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posaconazole PillAlso: Noxafil300 mg (three 100 mg tablets) orally | Drug | Posaconazole |
Primary outcome
Posaconazole Concentration in Cerebrospinal Fluid Using Microdialysis Catheters
Time frame: Collected over a 24-hour period after surgery (biopsy or resection)
Assessment of the concentration of drug in the dialysate fluid.
7 secondary outcomes
Number of Participants Able to Tolerate Preoperative Steady-state Dosing of Posaconazole
Time frame: from Baseline to Visit 7 (14 days +/- 7 days post-op)
Posaconazole Effect on Hexokinase 2 Concentration Within Tumor Tissue
Time frame: Within 24 hours after biopsy or tumor resection
Posaconazole Effect on Tumor Proliferation in Tumor Tissue
Time frame: Within 24 hours after biopsy or tumor resection
Posaconazole Effect on Cell Death in Tumor Tissue
Time frame: Within 24 hours after biopsy or tumor resection
Posaconazole Effect on Angiogenesis in Tumor Tissue
Time frame: Within 24 hours after biopsy or tumor resection
Correlation of Neuro-pharmacokinetic Profile of Posaconazole With Lactate Concentration
Time frame: Collected over a 24-hour period after surgery (biopsy or resection)
Correlation of Neuro-pharmacokinetic Profile of Posaconazole With Pyruvate Concentration
Time frame: Collected over a 24-hour period after surgery (biopsy or resection)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42494994Mansouri A, de Macedo Filho L, Tufano E, Laukhuff H, Zacharia B, Neighbors J, Green M, Derosia N, Sun D, Bhanja D, Tuohy K, Connor J, Aregawi DG, Glantz M, Zadeh G. A phase 0 clinical trial to evaluate the neuropharmacological profile of posaconazole for glioblastoma. Neurooncol Adv. 2026 Jul 2;8(1):vdag174. doi: 10.1093/noajnl/vdag174. eCollection 2026 Jan-Dec.
- Derived from this study: PubMed 35861778Bhanja D, Neighbors J, Connor J, Zadeh G, Mansouri A. Neuropharmacological Study of Posaconazole for Glioblastoma: A Phase 0 Clinical Trial Protocol. Neurosurgery. 2022 Oct 1;91(4):658-665. doi: 10.1227/neu.0000000000002071. Epub 2022 Jul 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alireza Mansouri, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Posaconazole Pill in people with Glioblastoma and Glioblastoma Multiforme, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posaconazole Concentration in Cerebrospinal Fluid Using Microdialysis Catheters (time frame: Collected over a 24-hour period after surgery (biopsy or resection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04825275, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.