NCT03875859

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

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Kavita Sarin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Remetinostat	Topical 1% remetinostat gel

Timeline

• Start date: 2019-12-12
• Primary completion: 2020-05-14
• Completion: 2021-01-30
• First posted: 2019-03-15
• Last updated: 2021-05-20
• Results posted: 2021-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study