A Phase 2 interventional study of Remetinostat in Skin Basal Cell Carcinoma, sponsored by Kavita Sarin. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-08.
Sponsored by Kavita Sarin · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 30 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Kavita Sarin is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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:
Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Remetinostat
Applied topically under bandage occlusion
Also known as: suberohydroxamic acid phenyl ester (SHAPE); SHAPE Gel; SHP 141; and 4 [[8 (hydroxyamino) 1,8 dioxooctyl]oxy] benzoic acid methyl ester
Overall Response Rate
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.
Time frame: At 6 weeks
Number of Participants With a Decrease in Expression of the Hedgehog Biomarker Gene GLI1
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.
Time frame: 6 weeks
Adverse Events Contributing to Treatment Discontinuation or Interruption
Adverse events (AEs) contributing to treatment discontinuation or interruption are reported as the number of such events, a number without dispersion.
Time frame: 6 weeks
Participants Who Discontinued Treatment or Had Treatment Interruption
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.
Time frame: 6 weeks
| Milestone | Treatment (Remetinostat) |
|---|---|
| Started | 30 |
| Completed | 27 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Eligible and enrolled, but withdrawn due to abnormal baseline laboratory values. | 1 |
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.
| percentage of tumor lesions | Treatment (Remetinostat) |
|---|---|
| Overall Response Rate | 69.7 (54.0 to 82.5) |
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.
| Participants | Treatment (Remetinostat) |
|---|---|
| Number of Participants With a Decrease in Expression of the Hedgehog Biomarker Gene GLI1 | 5 |
Adverse events (AEs) contributing to treatment discontinuation or interruption are reported as the number of such events, a number without dispersion.
| adverse events | Treatment (Remetinostat) |
|---|---|
| AEs contributing to treatment interruption | 9 |
| AEs contributing to treatment discontinuation | 3 |
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.
| Participants | Treatment (Remetinostat) |
|---|---|
| Participants who experienced treatment interruption | 5 |
| Participants who discontinued treatment | 3 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Remetinostat) | 0/29 (0%) | 0/29 (0%) | 29/29 (100%) |
| Event | Treatment (Remetinostat) |
|---|---|
| EczemaSkin and subcutaneous tissue disorders | 27/29 |
| Pain of SkinSkin and subcutaneous tissue disorders | 6/29 |
| PruritisSkin and subcutaneous tissue disorders | 1/29 |
| Skin UlcerationSkin and subcutaneous tissue disorders | 1/29 |
| Skin and subcutaneous tissue disorders - Other, tumor hemorrhageSkin and subcutaneous tissue disorders | 1/29 |
| Age, Categorical(Participants) | Treatment (Remetinostat) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 21 |
| >=65 years | 9 |
| Age, Continuous(years) | Treatment (Remetinostat) |
|---|---|
| Mean | 59.26 ± 10.6 |
| Sex: Female, Male(Participants) | Treatment (Remetinostat) |
|---|---|
| Female | 11 |
| Male | 19 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Remetinostat) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 27 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Treatment (Remetinostat) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Treatment (Remetinostat) |
|---|---|
| United States | 30 |
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