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ACTIVE NOT RECRUITING
NCT07585851
EARLY_PHASE1

Administration of Repurposed Ketoconazole in Glioma Patients

Sponsor: Universitas Padjadjaran

View on ClinicalTrials.gov

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

Interventions

DRUG

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