Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT03180528|
Recruitment Status : Active, not recruiting
First Posted : June 8, 2017
Results First Posted : January 5, 2021
Last Update Posted : January 5, 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|
|Estimated 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 >80% 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.
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|