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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Topical 1% remetinostat gel
Stanford Medical Center
Stanford, California, United States
Overall Response (OR)
Overall response (OR) will be assessed in squamous cell carcinoma (SCC). Objective response (OR) will defined as the number of lesions with either a complete response (CR) or a partial response (PR) among all eligible and treated lesions, any time within 10 weeks. * Complete Response (CR) = Disappearance of target lesion * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesion * Overall Response (OR) = CR + PR
Time frame: 10 weeks
Adverse Events Contributing to Treatment Discontinuation or Interruption
Adverse events (AEs) contributing to treatment discontinuation or interruption are reported as the number of such events, a number without dispersion.
Time frame: 8 weeks
Participants Who Discontinued Treatment or Had Treatment Interruption
The number of participants who discontinued treatment or experienced treatment interruption within the first 8 weeks of treatment are reported as the number of such participants, a number without dispersion.
Time frame: 8 weeks
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