At a glance
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Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients With Basal Cell Carcinomas
In Brief
A Phase 2 clinical trial evaluating Itraconazole for Basal Cell Carcinoma (BCC) and Skin Cancer. Completed, enrolled 29 participants across 1 site.
Detailed Summary
Basal cell carcinomas (BCCs) are the most common human cancer in the US and affect over 1 million people. There is no effective drug to prevent basal cell carcinomas of the skin. We hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of BCC development. Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. It has been shown in mice to reduce a BCC biomarker and to reduce growth of BCCs. Thus, it may reduce BCC growth in humans.
Study Details
Timeline
Interventions
* Cohort A: oral itraconazole 400 mg as 200 mg twice daily; for 1 month * Cohort B: oral itraconazole 200 mg as 100 mg twice daily; for up to 3 months