Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer

A Phase 2 Open-Label, Single-Arm Trial of the Efficacy of Topical Remetinostat on Basal Cell Carcinoma in Patients

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.

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.

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