Clinical trial · Interventional
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
NCT03180528CI-TRIAL-00052142completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Basal Cell Carcinoma | Skin Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remetinostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (remetinostat)
- description
- Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Remetinostat
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- At 6 weeks
- description
- Overall response is defined as achieving either a complete response (CR) or a partial response (PR). Response is based on the Response Evaluation Criteria in Solid Tumors (RECIST), as follows. * CR = tumor lesion becomes undetectable * PR = ≥30% decrease in total tumor diameter * Overall response (OR) = CR+PR * Stable Disease (SD) = decrease in total tumor diameter is \>0% and \<30% * Progressive Disease (PD) = increase in total tumor diameter Exact binomial 90% confidence intervals (90%) will be computed for OR. The data are reported accord to the per protocol analysis, ie, including lesions for subjects who were \<70% compliant with drug treatment. For subjects who were compliant but dropped out, data from their last study visit will be used if they contribute a biopsy. The analysis population will include the participants who have provided pre-treatment and post-treatment biopsies. The outcome is reported as the percent of tumor lesions that achieve OR, with 90% CI.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.