Can a common antifungal drug help fight brain cancer? new study investigates

NCT ID NCT07585851

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial is testing whether ketoconazole, a drug normally used for fungal infections, can get into brain tumors (gliomas) in enough amounts to possibly slow their growth. About 80 adults with different grades of glioma will take low doses of the drug before their scheduled surgery. Researchers will measure drug levels in the tumor tissue and blood to see if it crosses the blood-brain barrier, which could lead to future studies using similar drugs for glioma treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

80 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants aged 18 years or older. * Radiological confirmation of an intra-axial primary brain tumor (all grades) requiring surgical intervention. * Karnofsky Performance Status (KPS) of ≥60 and projected life expectancy exceeding 12 weeks. * Normal liver function, indicated by alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within 1.5x the upper limit of normal (ULN). * Normal renal function, defined as urea within 16.6-48.5 mg/dL, creatinine within 0.67-1.17 mg/dL, and/or eGFR ≥90 (within 1.5x the institutional ULN) . * Capacity to take oral medications. * Women of reproductive age and all male participants must commit to effective contraception (e.g., hormonal methods) throughout the trial. * Willingness and ability to provide written informed consent. * Commitment to adhere to the protocol, including treatment, procedures, and scheduled follow-ups. Exclusion Criteria: * Known hypersensitivity to ketoconazole. * Prior severe reactions (e.g., agranulocytosis, neutropenia) to ketoconazole or other azole antifungals used for parasitic conditions. * History of acute or chronic hepatitis. * Elevated liver enzymes (ALT, AST) or impaired renal function (urea, creatinine, eGFR) exceeding 1.5x ULN per local lab standards. * Current use of metronidazole without ability to switch to an alternative antibiotic at least 7 days prior to ketoconazole initiation. * Azole antifungal use within the preceding 3 months. * Pregnancy or breastfeeding. * Any coexisting medical, psychiatric, or lab abnormality that, per investigator judgment, heightens study risks or confounds data interpretation. * Unavailability for follow-up or inability to fulfill protocol demands. * Concurrent use of ketoconazole metabolic inducers (e.g., isoniazid, nevirapine, rifampin, rifabutin) without discontinuation option.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Brain Center Hospital Prof. Dr. dr. Mahar Mardjono

    Jakarta, Jakarta Special Capital Region, 13630, Indonesia

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