Clinical Trials /

Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer

NCT03180528

Description:

This phase II trial studies how well remetinostat works in treating patients with skin basal cell cancer. Remetinostat may slow the growth of basal cell cancer cells.

Related Conditions:
  • Basal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer
  • Official Title: A Phase 2 Open-Label, Single-Arm Trial of the Efficacy of Topical Remetinostat on Basal Cell Carcinoma in Patients

Clinical Trial IDs

  • ORG STUDY ID: SKIN0037
  • SECONDARY ID: NCI-2017-00981
  • SECONDARY ID: 40947
  • NCT ID: NCT03180528

Conditions

  • Skin Basal Cell Carcinoma

Interventions

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

Purpose

This phase II trial studies how well remetinostat works in treating patients with skin basal cell cancer. Remetinostat may slow the growth of basal cell cancer cells.

Detailed Description

      PRIMARY OBJECTIVES:

      I. Overall response rate of basal cell carcinoma (BCC) in subjects at 6 weeks.

      SECONDARY OBJECTIVES:

      I. Suppression of GLI1 (glioma-associated oncogene) expression in treated BCCs as compared
      with baseline.

      II. Safety assessment of Remetinostat after 6 weeks of topical treatment.

      OUTLINE:

      Tumors receive Remetinostat topically three times per day (TID) for 6 weeks in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed for at least 4 weeks.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (remetinostat)ExperimentalPatients receive remetinostat topically TID for 6 weeks in the absence of disease progression or unacceptable toxicity.
  • Remetinostat

Eligibility Criteria

        Inclusion Criteria:

          -  Must have at least one BCC lesion > 1 cm (BCC > 5 mm) in non-cosmetically sensitive
             site(s)

          -  Must be willing to apply the topical remetinostat 3 times daily for 6 weeks

          -  For women of child bearing potential, a negative urine pregnancy test

          -  Women of child bearing potential are expected to use an effective method of birth
             control while participating in the study and for 1 month after applying the last dose

          -  For male subjects with female partners of childbearing potential, agreement to use
             adequate contraception while participating in the study and for 1 month after applying
             the last dose

          -  Has signed and dated the current Institutional Review Board (IRB) approved informed
             consent document

        Exclusion Criteria:

          -  Taking any medication known to interact with histone deacetylase (HDAC) inhibitors,
             such as valproate or anticoagulants

          -  Taking any medication known to affect hedgehog (HH) signaling pathway such as
             itraconazole

          -  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 to the study tumors of:

               -  Glucocorticoids

               -  Retinoids either systemically or topically (eg, etretinate, isotretinoin,
                  tazarotene, tretinoin, adapalene)

               -  Alpha hydroxy acids (eg, glycolic acid, lactic acid) to > 5% of the skin

               -  5 fluorouracil or imiquimod and/or

               -  Itraconazole

          -  Has received treatment with systemic chemotherapy or agents known to be inhibitors of
             HH signaling, within 60 days to starting study medication

          -  Currently receiving systemic medications that could affect BCC tumors (eg, 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 severe immunosuppression due to disease or medication

          -  Known or previous hypersensitivity to histone deacetylase inhibitor (HDACi)

          -  History of congestive heart failure; cardiac arrhythmias; or other findings of
             ventricular dysfunction

          -  History of current evidence of malabsorption or liver disease

          -  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 as assessed using Response Evaluation Criteria in Solid Tumors
Time Frame:At 6 weeks
Safety Issue:
Description:Overall response rate will be defined as the proportion of subjects with either a complete response or a partial response among all eligible and treated subjects. Exact binomial 90% confidence intervals will be computed for the overall response rate. The data will be analyzed first by intention to treat analysis and then per protocol analysis by only including subjects that are > 80% compliant with drug treatment. For subjects who drop out, data from their last study visit will be used if they contribute a biopsy. The analysis population will include participants who have consented to undergo

Details

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

Last Updated

December 3, 2019