Clinical Trials /

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

NCT03875859

Description:

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

Related Conditions:
  • Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: IRB-49542
  • SECONDARY ID: SKIN0050
  • NCT ID: NCT03875859

Conditions

  • Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
Remetinostatsuberohydroxamic acid phenyl ester (SHAPE); SHAPE Gel;, SHP-141;, and 4-[[8-(hydroxyamino)-1,8-dioxooctyl]oxy]-benzoic acid methyl esterRemetinostat

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
RemetinostatExperimentalSubjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily.
  • Remetinostat

Eligibility Criteria

        Inclusion Criteria:

          1. 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.

          2. 18 years of age or older.

          3. Must be willing to apply the topical remetinostat 3 times daily for 8 weeks and cover
             with an occlusive bandage.

          4. 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)

          5. 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

          6. Has signed and dated the current, approved informed consent document.

        Exclusion Criteria:

          1. Any large (> 20 mm) SCC lesion. Patients with large SCC lesion(s) will be referred for
             evaluation for surgical resection.

          2. Inoperable locally-advanced and/or non-cutaneous metastatic SCC.

          3. 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.)

          4. Taking any medication known to affect SCC growth

          5. 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

               -  5-fluorouracil or imiquimod

          6. Has received treatment with systemic chemotherapy within 60 days prior to starting
             study medication.

          7. Currently receiving systemic medications that could affect SCC tumors (e.g., oral
             retinoids) or might interact with remetinostat

          8. 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.

          9. 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)

         10. Known or previous hypersensitivity to HDACi

         11. History of congestive heart failure, cardiac arrhythmias, or other findings of
             ventricular dysfunction.

         12. Pregnancy or breast-feeding.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:10 weeks
Safety Issue:
Description:Overall response rate (ORR) will be assessed in squamous cell carcinoma (SCC). Objective response rate (ORR) will defined as the proportion of subjects with either a complete response (CR) or a partial response (PR) among all eligible and treated subjects. Complete Response (CR) = Disappearance of all target lesions Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kavita Sarin

Last Updated

December 4, 2019