Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Anti-Infective Agents

All Drugs and Chemicals

Benzoic Acid

Clotrimazole

Miconazole

Antifungal Agents

Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity.

Applied topically under bandage occlusion

Remetinostat

Kavita Sarin

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.

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

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.

The effect of topical remetinostat gel 1% on decreasing expression of Hedgehog biomarker gene GLI1 was determined using the RNeasy Fibrous Tissue Mini Kit (Qiagen, Valencia, CA), a polymerase chain reaction (PCR) test kit. The levels observed at baseline and after 6 weeks treatment were obtained. The outcome is reported as the number of subjects for whom a decrease in expression of the Hedgehog biomarker gene GLI1 was observed, a number without dispersion.

Adverse events (AEs) contributing to treatment discontinuation or interruption are reported as the number of such events, a number without dispersion.

The number of participants who discontinued treatment or experienced treatment interruption within the first 6 weeks of treatment are reported as the number of such participants, a number without dispersion.

Medivir

National Institutes of Health (NIH)

American Skin Association

Principal Investigator

Data are reported for subjects that received the study treatment only. Subjects who were enrolled, but were withdrawn without receiving study treatment due to abnormal baseline laboratory values are not included.

Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity.

Remetinostat: Applied topically under bandage occlusion

Treatment (Remetinostat)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Kavita Yang Sarin

Analysis is on a per-lesion basis, and not a per-participant basis. Per protocol, analysis does not include lesions from participants \<70% compliant with treatment regimen.

Overall Response Rate

Results are reported for those participants for whom baseline and 6-week analysis data were available. The COVID-19 epidemic adversely affected the ability of the laboratory to process and return results.

Number of Participants With a Decrease in Expression of the Hedgehog Biomarker Gene GLI1

AEs contributing to treatment interruption

AEs contributing to treatment discontinuation

The outcome is reported as a number of adverse events (AEs), not as a number of participants. For some participants, multiple AEs contributing to treatment decisions.

Spots Global Cancer Trial Database for Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial