Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer

Completed · Phase 2

Conditions studied: Skin Basal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT03180528

Run by

Kavita Sarin

People needed

30

Starts

2018-07-07

Expected to finish

2020-12-31

Last updated by the study team

2021-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University, School of Medicine — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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