Topical Itraconazole in Treating Patients With Basal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT02735356|
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Skin Basal Cell Carcinoma||Drug: Itraconazole Other: Placebo||Early Phase 1|
I. To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).
I. To determine if topical itraconazole gel will decrease BCC size.
Patients apply itraconazole topically twice daily (BID) and placebo topically BID for 12 weeks.
After completion of study treatment, patients are followed up for up to 14 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients|
|Actual Study Start Date :||May 5, 2016|
|Actual Primary Completion Date :||September 19, 2017|
|Actual Study Completion Date :||October 10, 2017|
Experimental: Treatment (itraconazole and placebo)
Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
- Percentage change of GLi levels in treated vs untreated tumors [ Time Frame: Up to 1 month ]will be assessed as relative GLi1 mRNA expression
- Change in BCC tumor size [ Time Frame: At baseline, 1, 4, and 12 weeks ]Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735356
|United States, California|
|Stanford Cancer Institute|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Anthony Oro||Stanford Cancer Institute|