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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
Sponsor:
Collaborators:
Medivir
National Institutes of Health (NIH)
American Skin Association
Information provided by (Responsible Party):
Kavita Sarin, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Skin Basal Cell Carcinoma Drug: Remetinostat Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Remetinostat
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have at least one BCC lesion > 1 cm (BCC > 5 mm) in non-cosmetically sensitive site(s)
  • Must be willing to apply the topical remetinostat 3 times daily for 6 weeks
  • For women of child bearing potential, a negative urine pregnancy test
  • Women of child bearing potential are expected to use an effective method of birth control while participating in the study and for 1 month after applying the last dose
  • For male subjects with female partners of childbearing potential, agreement to use adequate contraception while participating in the study and for 1 month after applying the last dose
  • Has signed and dated the current Institutional Review Board (IRB) approved informed consent document

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:

    • Glucocorticoids
    • Retinoids either systemically or topically (eg, etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
    • Alpha hydroxy acids (eg, glycolic acid, lactic acid) to > 5% of the skin
    • 5 fluorouracil or imiquimod and/or
    • Itraconazole
  • 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

Information from the National Library of Medicine

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


Locations
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United States, California
Stanford University, School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Kavita Sarin
Medivir
National Institutes of Health (NIH)
American Skin Association
Investigators
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Principal Investigator: Kavita Sarin Stanford University
  Study Documents (Full-Text)

Documents provided by Kavita Sarin, Stanford University:
Informed Consent Form  [PDF] April 15, 2020

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Responsible Party: Kavita Sarin, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03180528    
Other Study ID Numbers: IRB-40947
NCI-2017-00981 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SKIN0037 ( Other Identifier: Stanford )
First Posted: June 8, 2017    Key Record Dates
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Benzoic Acid
Antifungal Agents
Anti-Infective Agents