Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase 2 trial studies how well remetinostat works in treating patients with skin basal cell cancer. Remetinostat may slow the growth of basal cell cancer cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kavita Sarin
• Collaborators: American Skin Association; Medivir; National Institutes of Health (NIH)
• Treatments: Benzoic Acid; Enzyme Inhibitors

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