Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-01-11 @ 11:26 AM
Study NCT ID:
NCT03875859
Status:
TERMINATED
Last Update Posted:
2021-05-20
First Post:
2019-03-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)
Sponsor:
Kavita Sarin
Organization:
Study Overview
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)
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The available study medication reached expiry (logistics).
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SKIN0050 | OTHER | OnCore | View |