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Administration of Repurposed Ketoconazole in Glioma Patients
Sponsor: Universitas Padjadjaran
Summary
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.
Official title: Administration of Repurposed Ketoconazole in Glioma Patients: Early Phase 1 Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-02-28
Completion Date
2026-08
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
Ketoconazole
Dose: 400 mg (two 200 mg tablets) orally.
Locations (1)
National Brain Center Hospital Prof. Dr. dr. Mahar Mardjono
Jakarta, Jakarta Special Capital Region, Indonesia