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

NCT03875859 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB-49542SKIN0050
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  10 weeks

Secondary Outcomes (2)

• Adverse Events Contributing to Treatment Discontinuation or Interruption

  8 weeks

• Participants Who Discontinued Treatment or Had Treatment Interruption

  8 weeks

Study Arms (1)

Remetinostat

EXPERIMENTAL

Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily.

Drug: Remetinostat

Interventions

Remetinostat DRUG

Topical 1% remetinostat gel

Also known as: suberohydroxamic acid phenyl ester (SHAPE); SHAPE Gel;, SHP-141;, and 4-[[8-(hydroxyamino)-1,8-dioxooctyl]oxy]-benzoic acid methyl ester

Remetinostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have at least one biopsy-proven cutaneous SCC or SCC in situ (SCC-IS) lesion greater than or equal to 5 mm. Non-invasive SCC lesion(s), including Bowen's disease (SCC-IS), are eligible, but must be amenable to surgical resection.
• years of age or older.
• Must be willing to apply the topical remetinostat 3 times daily for 8 weeks and cover with an occlusive bandage.
• Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months)
• Sexually active women of child bearing potential (WCBP) and male patients with a female partner of child-bearing potential must agree to use acceptable methods of contraception to avoid pregnancy (for example, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) before the first dose of study therapy and for 3 months after the last dose of study therapy
• Has signed and dated the current, approved informed consent document.

You may not qualify if:

• Any large (\> 20 mm) SCC lesion. Patients with large SCC lesion(s) will be referred for evaluation for surgical resection.
• Inoperable locally-advanced and/or non-cutaneous metastatic SCC.
• SCC lesion(s) in cosmetically-sensitive areas (e.g. tip of nose, eyelid) are not eligible for enrollment. (If a patient has SCC lesion(s) in other areas, those tumor(s) may be considered for enrollment.)
• Taking any medication known to affect SCC growth
• Within the past 6 months, has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study. Specifically, these include the topical use at the site of the study tumors:
• Glucocorticoids
• Retinoids either systemically or topically at the tumor site (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
• Alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to the tumor site
• fluorouracil or imiquimod
• Has received treatment with systemic chemotherapy within 60 days prior to starting study medication.
• Currently receiving systemic medications that could affect SCC tumors (e.g., oral retinoids) or might interact with remetinostat
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements.
• Moderate to significant immunosuppression (e.g., active cancer, significant autoimmune disease) and/or receiving immunosuppressive drugs that result in moderate to significant immunosuppression (e.g. low dose oral glucocorticoids do not necessarily exclude a patient)
• Known or previous hypersensitivity to HDACi
• History of congestive heart failure, cardiac arrhythmias, or other findings of ventricular dysfunction.

Sponsors & Collaborators

• Kavita Sarin: lead
• Medivir: collaborator

Study Sites (1)

Stanford Medical Center

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

remetinostat

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Results Point of Contact

• Title: Kavita Yang Sarin
• Organization: Stanford University

ksarin@stanford.edu

650-804-2899

Study Officials

• Kavita Y Sarin, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Dermatology.

Model Details: Open label, single-arm study

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: December 12, 2019
• Primary Completion: May 14, 2020
• Study Completion: January 30, 2021
• Last Updated: May 20, 2021
• Results First Posted: May 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)