Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT03180528|
Recruitment Status : Completed
First Posted : June 8, 2017
Results First Posted : January 5, 2021
Last Update Posted : June 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Skin Basal Cell Carcinoma||Drug: Remetinostat||Phase 2|
I. Overall response rate of basal cell carcinoma (BCC) in subjects at 6 weeks.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-Label, Single-Arm Trial of the Efficacy of Topical Remetinostat on Basal Cell Carcinoma in Patients|
|Actual Study Start Date :||July 7, 2018|
|Actual Primary Completion Date :||July 7, 2020|
|Actual Study Completion Date :||December 31, 2020|
Experimental: Treatment (remetinostat)
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
Other Name: suberohydroxamic acid phenyl ester (SHAPE); SHAPE Gel; SHP 141; and 4 [[8 (hydroxyamino) 1,8 dioxooctyl]oxy] benzoic acid methyl ester
- Overall Response Rate [ Time Frame: At 6 weeks ]
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.
- Number of Participants With a Decrease in Expression of the Hedgehog Biomarker Gene GLI1 [ Time Frame: 6 weeks ]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 Contributing to Treatment Discontinuation or Interruption [ Time Frame: 6 weeks ]Adverse events (AEs) contributing to treatment discontinuation or interruption are reported as the number of such events, a number without dispersion.
- Participants Who Discontinued Treatment or Had Treatment Interruption [ Time Frame: 6 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180528
|United States, California|
|Stanford University, School of Medicine|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Kavita Sarin||Stanford University|