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Spots Global Cancer Trial Database for Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)

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Trial Identification

Brief Title: Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)

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)

Study ID: NCT03875859

Interventions

Remetinostat

Study Description

Brief Summary: The primary purpose of this study is to determine if 8 weeks of topical remetinostat applied three times daily will suppress Squamous Cell Carcinoma.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Stanford Medical Center, Stanford, California, United States

Contact Details

Name: Kavita Y Sarin, MD, PhD

Affiliation: Stanford University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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