Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase 2 Open Label, Single Arm Trial to Investigate the Efficacy and Safety of Topical Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of Squamous Cell Carcinoma (SCC)
The primary purpose of this study is to determine if 8 weeks of topical remetinostat applied three times daily will suppress Squamous Cell Carcinoma.
The primary purpose of this study is: - to determine if 8 weeks of topical remetinostat gel applied 3 times daily (TID) under occlusion will suppress SCC growth - to determine the overall response rate (ORR) of SCCs after 8 weeks of treatment with topical remetinostat gel 1%, as measured by at least 30% decrease in greatest area (in mm2). - Subjects with at least 1 biopsy-proven cutaneous SCC will be recruited for this study. - Subjects will apply remetinostat gel 1% to at least 1 SCC. - Non-invasive cutaneous SCC lesions, including Bowen's disease, are also eligible for this study - There is 1 treatment option: Topical remetinostat gel 1% applied 3 times daily. - The study is a single arm, open label design - For purposes of ClinicalTrials.gov, there is no secondary outcome. ;
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