Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)
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|ClinicalTrials.gov Identifier: NCT03875859|
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma||Drug: Remetinostat||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label, single-arm study|
|Masking:||None (Open Label)|
|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)|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||November 30, 2022|
Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily.
Remetinostat is a histone deacetylase inhibitor (HDACi) that was designed with a metabolically-labile ester bond so that topical application would produce effective local histone deacetylase (HDAC) inhibition in cutaneous lesions while resulting in only negligible systemic HDAC inhibition.
- Growth suppression of SCC tumors [ Time Frame: 8 weeks ]To determine if topical remetinostat gel will decrease SCC tumor area (in mm2) by at least 30% following 8 weeks' treatment. Gel will be applied 3 times daily.
- Overall response rate of SCC tumors [ Time Frame: 8 weeks ]A partial response is defined as at least 30% decrease in total tumor area at end of study from baseline. A complete response is undetectable tumor lesions at end of study. Objective response rate (ORR) will defined as the proportion of subjects with either a complete response or a partial response (PR) among all eligible and treated subjects.
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): NCT03875859
|Contact: Hanh Dofirstname.lastname@example.org|
|Contact: Irene Baileyemail@example.com|