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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00981 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| SKIN0037 | Other Identifier | Stanford |
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| Name | Class |
|---|---|
| Medivir | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
| American Skin Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (remetinostat) | Experimental | Patients receive topical remetinostat 1% gel applied TID directly to the lesion, for 6 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remetinostat | Drug | Applied topically under bandage occlusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| At 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Kavita Sarin | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Remetinostat: Applied topically under bandage occlusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Remetinostat: Applied topically under bandage occlusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.
| 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. | Posted | Number | 90% Confidence Interval | percentage of tumor lesions | At 6 weeks | Tumor lesions | Tumor lesions |
12 weeks
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Remetinostat: Applied topically under bandage occlusion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eczema | Skin and subcutaneous tissue disorders | CTCAE v5 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kavita Yang Sarin | Stanford University | (650) 723-6316 | ksarin@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2020 | Dec 10, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2020 | Jun 12, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000723518 | remetinostat |
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| 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. | 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. | 6 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. Remetinostat: Applied topically under bandage occlusion |
|
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | 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. | 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. | Posted | Number | adverse events | 6 weeks |
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|
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| Secondary | 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. | For some participants, multiple AEs contributing to the treatment decision. | Posted | Count of Participants | Participants | 6 weeks |
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| 0 |
| 29 |
| 0 |
| 29 |
| 29 |
| 29 |
| Pain of Skin | Skin and subcutaneous tissue disorders | CTCAE v5 | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | CTCAE v5 | Systematic Assessment |
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| Skin Ulceration | Skin and subcutaneous tissue disorders | CTCAE v5 | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, tumor hemorrhage | Skin and subcutaneous tissue disorders | CTCAE v5 | Systematic Assessment |
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| D018295 |
| Neoplasms, Basal Cell |