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Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)

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ClinicalTrials.gov Identifier: NCT03875859
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Kavita Sarin, Stanford University

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date March 15, 2019
Estimated Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Growth suppression of SCC tumors [ Time Frame: 8 weeks ]
    To determine if topical remetinostat gel will decrease SCC tumor area (in mm2) by at least 30% following 8 weeks' treatment. Gel will be applied 3 times daily.
  • Overall response rate of SCC tumors [ Time Frame: 8 weeks ]
    A partial response is defined as at least 30% decrease in total tumor area at end of study from baseline. A complete response is undetectable tumor lesions at end of study. Objective response rate (ORR) will defined as the proportion of subjects with either a complete response or a partial response (PR) among all eligible and treated subjects.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)
Official Title  ICMJE A Phase 2 Open Label, Single Arm Trial to Investigate the Efficacy and Safety of Topical Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of Squamous Cell Carcinoma (SCC)
Brief Summary The primary purpose of this study is to determine if 8 weeks of topical remetinostat applied three times daily will suppress Squamous Cell Carcinoma.
Detailed Description

The primary purpose of this study is:

  • to determine if 8 weeks of topical remetinostat gel applied 3 times daily (TID) under occlusion will suppress SCC growth
  • to determine the overall response rate (ORR) of SCCs after 8 weeks of treatment with topical remetinostat gel 1%, as measured by at least 30% decrease in greatest area (in mm2).

    • Subjects with at least 1 biopsy-proven cutaneous SCC will be recruited for this study.
    • Subjects will apply remetinostat gel 1% to at least 1 SCC.
    • Non-invasive cutaneous SCC lesions, including Bowen's disease, are also eligible for this study
    • There is 1 treatment option: Topical remetinostat gel 1% applied 3 times daily.
    • The study is a single arm, open label design
    • For purposes of ClinicalTrials.gov, there is no secondary outcome.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Open label, single-arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma
Intervention  ICMJE Drug: Remetinostat
Remetinostat is a histone deacetylase inhibitor (HDACi) that was designed with a metabolically-labile ester bond so that topical application would produce effective local histone deacetylase (HDAC) inhibition in cutaneous lesions while resulting in only negligible systemic HDAC inhibition.
Other Names:
  • suberohydroxamic acid phenyl ester (SHAPE); SHAPE Gel;
  • SHP-141;
  • and 4-[[8-(hydroxyamino)-1,8-dioxooctyl]oxy]-benzoic acid methyl ester
Study Arms  ICMJE Experimental: Remetinostat
Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily.
Intervention: Drug: Remetinostat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2022
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Must have at least one biopsy-proven cutaneous SCC or SCC in situ (SCC-IS) lesion greater than or equal to 5 mm. Non-invasive SCC lesion(s), including Bowen's disease (SCC-IS), are eligible, but must be amenable to surgical resection.
  2. 18 years of age or older.
  3. Must be willing to apply the topical remetinostat 3 times daily for 8 weeks and cover with an occlusive bandage.
  4. Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months)
  5. Sexually active women of child bearing potential (WCBP) and male patients with a female partner of child-bearing potential must agree to use acceptable methods of contraception to avoid pregnancy (for example, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) before the first dose of study therapy and for 3 months after the last dose of study therapy
  6. Has signed and dated the current, approved informed consent document.

Exclusion Criteria:

  1. Any large (> 20 mm) SCC lesion. Patients with large SCC lesion(s) will be referred for evaluation for surgical resection.
  2. Inoperable locally-advanced and/or non-cutaneous metastatic SCC.
  3. SCC lesion(s) in cosmetically-sensitive areas (e.g. tip of nose, eyelid) are not eligible for enrollment. (If a patient has SCC lesion(s) in other areas, those tumor(s) may be considered for enrollment.)
  4. Taking any medication known to affect SCC growth
  5. 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 at the site of the study tumors:

    • Glucocorticoids
    • Retinoids either systemically or topically at the tumor site (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
    • Alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to the tumor site
    • 5-fluorouracil or imiquimod
  6. Has received treatment with systemic chemotherapy within 60 days prior to starting study medication.
  7. Currently receiving systemic medications that could affect SCC tumors (e.g., oral retinoids) or might interact with remetinostat
  8. 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.
  9. Moderate to significant immunosuppression (e.g., active cancer, significant autoimmune disease) and/or receiving immunosuppressive drugs that result in moderate to significant immunosuppression (e.g. low dose oral glucocorticoids do not necessarily exclude a patient)
  10. Known or previous hypersensitivity to HDACi
  11. History of congestive heart failure, cardiac arrhythmias, or other findings of ventricular dysfunction.
  12. Pregnancy or breast-feeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hanh Do 6502060647 hanhndo@stanford.edu
Contact: Irene Bailey 6507217149 baileyhi@stanford.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03875859
Other Study ID Numbers  ICMJE 49542
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Results will be shared at scientific meetings and submitted for publishing.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will be available 1 year after primary completion date.
Responsible Party Kavita Sarin, Stanford University
Study Sponsor  ICMJE Kavita Sarin
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP