Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer
Trial ID or NCT#
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.
A Phase 2 Open-Label, Single-Arm Trial of the Efficacy of Topical Remetinostat on Basal Cell Carcinoma in Patients
- - 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
- - 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
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