Clinical trial · Interventional
Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas
Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients With Basal Cell Carcinomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma (BCC) | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Itraconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A - Itraconazole 400 mg
- description
- Oral itraconazole 400 mg as 200 mg twice daily, for 1 month, stratified by prior vismodegib history
- interventionNames
- Drug: Itraconazole
- type
- EXPERIMENTAL
- label
- Cohort B - Itraconazole 200 mg
- description
- Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months
- interventionNames
- Drug: Itraconazole
- type
- NO_INTERVENTION
- label
- Untreated Control
- description
- Patients otherwise eligible but unwilling to take itraconazole were enrolled onto the control arm of the study and received no treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA * At least one BCC tumor (greater than 4 mm in diameter) at any skin location, to be biopsied and surgically removed. * Had at least one liver function test \[eg, aspartate aminotransferase (AST), alanine aminotransferase (ALT)\] with normal results in the last year. * Consent to research use of their BCC tissue. * Cohort A or B: Willing to take itraconazole during the 2 to 3 weeks between biopsy and surgical removal of BCC EXCLUSION CRITERIA * History or current hepatitis or other liver disease. * Currently taking systemic medications that would affect BCC tumors (oral retinoids) or metabolism of itraconazole (anti-convulsants, corticosteroids) * History or current evidence of malabsorption or liver disease within the one year prior to enrollment. * History or current evidence of hyperthyroidism increasing metabolism of itraconazole * Unable to attend to 2nd study visit at Stanford for Mohs surgical excision * Current immunosuppression disease (cancer, autoimmune disease) * Receiving immunosuppressive drugs * Pregnant * Lactating * Any female actively trying to become pregnant
References
Publications (1)
- RESULTKim DJ, Kim J, Spaunhurst K, Montoya J, Khodosh R, Chandra K, Fu T, Gilliam A, Molgo M, Beachy PA, Tang JY. Open-label, exploratory phase II trial of oral itraconazole for the treatment of basal cell carcinoma. J Clin Oncol. 2014 Mar 10;32(8):745-51. doi: 10.1200/JCO.2013.49.9525. Epub 2014 Feb 3. PMID 24493717