NCT07585851Active, not recruitingEarly phase 1
Administration of Repurposed Ketoconazole in Glioma Patients
Administration of Repurposed Ketoconazole in Glioma Patients: Early Phase 1 Clinical Trial
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
This early phase 1 clinical trial tests whether ketoconazole, an antifungal drug, can penetrate primary glioma brain tumors through the blood-brain barrier at levels sufficient to disrupt tumor growth, based on preclinical studies targeting glucose metabolism. Gliomas, especially aggressive high-grade types (WHO grades III-IV), have limited treatments like surgery, radiation, or chemotherapy. Patients with low- or high-grade gliomas will receive single or repeated low doses of ketoconazole before scheduled surgery, tailored to their health and procedure timing. During surgery, drug levels will be measured in tumor tissue and plasma. Results will guide future trials exploring azole drugs as glioma therapies.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 6 May 2026
- Start date
- 28 Feb 2023
- Primary completion date
- 25 Sept 2024
- Lead sponsor
- Universitas Padjadjaran
- Diseases
- Glioblastoma
- NCT number
- NCT07585851
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 80
- From 28 Feb 2023 to the primary completion date, 25 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior severe reactions (e.g., agranulocytosis, neutropenia) to ketoconazole or other azole antifungals used for parasitic conditions.
- Current use of metronidazole without ability to switch to an alternative antibiotic at least 7 days prior to ketoconazole initiation.
- Concurrent use of ketoconazole metabolic inducers (e.g., isoniazid, nevirapine, rifampin, rifabutin) without discontinuation option.
Other illness
- Known hypersensitivity to ketoconazole.
- History of acute or chronic hepatitis.
- Any coexisting medical, psychiatric, or lab abnormality that, per investigator judgment, heightens study risks or confounds data interpretation.
Lab values
- Elevated liver enzymes (ALT, AST) or impaired renal function (urea, creatinine, eGFR) exceeding 1.5x ULN per local lab standards.
Other
- Azole antifungal use within the preceding 3 months.
- Pregnancy or breastfeeding.
- Unavailability for follow-up or inability to fulfill protocol demands.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Brain Center Hospital Prof. Dr. dr. Mahar Mardjono Coordinator of this site? Confirm its status | Jakarta | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.