Squamous Cell CarcinomaPhase 2NCT03875859
Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)
A Phase 2 study testing Remetinostat in people with Squamous Cell Carcinoma, run by Kavita Sarin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- Remetinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2019to 30 Jan 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 18 years of age or older.
- Must be willing to apply the topical remetinostat 3 times daily for 8 weeks and cover with an occlusive bandage.
- 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)
- 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
- Has signed and dated the current, approved informed consent document.
Who cannot join
- Any large (> 20 mm) SCC lesion. Patients with large SCC lesion(s) will be referred for evaluation for surgical resection.
- Inoperable locally-advanced and/or non-cutaneous metastatic SCC.
- 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.)
- Taking any medication known to affect SCC growth
- 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
Show all 16Show fewer
- 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
- Has received treatment with systemic chemotherapy within 60 days prior to starting study medication.
- Currently receiving systemic medications that could affect SCC tumors (e.g., 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 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)
- Known or previous hypersensitivity to HDACi
- History of congestive heart failure, cardiac arrhythmias, or other findings of ventricular dysfunction.
- Pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
The primary purpose of this study is to determine if 8 weeks of topical remetinostat applied three times daily will suppress Squamous Cell Carcinoma.
Read the 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.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- Remetinostat
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemetinostatDrug
Also called suberohydroxamic acid phenyl ester (SHAPE); SHAPE Gel;, SHP-141;, and 4-[[8-(hydroxyamino)-1,8-dioxooctyl]oxy]-benzoic acid methyl ester
Topical 1% remetinostat gel
| Study group | Role | What they receive |
|---|---|---|
| Remetinostat | Experimental | Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily. Receives: Drug: Remetinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response (OR)
Overall response (OR) will be assessed in squamous cell carcinoma (SCC). Objective response (OR) will defined as the number of lesions with either a complete response (CR) or a partial response (PR) among all eligible and treated lesions, any time within 10 weeks.
- Complete Response (CR) = Disappearance of target lesion
- Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesion
- Overall Response (OR) = CR + PR
Measured: 10 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
Participants Who Discontinued Treatment or Had Treatment Interruption
The number of participants who discontinued treatment or experienced treatment interruption within the first 8 weeks of treatment are reported as the number of such participants, a number without dispersion.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start12 Dec 2019
- Primary completion14 May 2020
- Study completion30 Jan 2021
Why it stopped: The available study medication reached expiry (logistics).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single-arm study
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kavita Sarin
- Sponsor type
- University, hospital or other
- Collaborators
- Medivir
- Responsible party
- Sponsor-investigator, Kavita Sarin, Stanford University
- Investigators
- Kavita Y Sarin, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875859
- Sponsor's protocol ID
- IRB-49542
- Other IDs
- SKIN0050
- Status last verified
- Apr 2021
- First submitted
- 13 Mar 2019
- Last updated
- 20 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03875859
- Acronym / sponsor ID
- IRB-49542
- Conditions
- Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The available study medication reached expiry (logistics).
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Kavita SarinUniversity, hospital or other
- Collaborators
- Medivir
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Posted 20 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single-arm study
| Arm | Type | Receives |
|---|---|---|
| Remetinostat | Experimental | Drug: RemetinostatSubjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 18 years of age or older.
- Must be willing to apply the topical remetinostat 3 times daily for 8 weeks and cover with an occlusive bandage.
- 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)
- 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
Key exclusion criteria (16 listed)
- Any large (> 20 mm) SCC lesion. Patients with large SCC lesion(s) will be referred for evaluation for surgical resection.
- Inoperable locally-advanced and/or non-cutaneous metastatic SCC.
- 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.)
- Taking any medication known to affect SCC growth
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemetinostatAlso: suberohydroxamic acid phenyl ester (SHAPE); SHAPE Gel;, SHP-141;, and 4-[[8-(hydroxyamino)-1,8-dioxooctyl]oxy]-benzoic acid methyl esterTopical 1% remetinostat gel | Drug | Remetinostat |
Primary outcome
Overall Response (OR)
Time frame: 10 weeks
Overall response (OR) will be assessed in squamous cell carcinoma (SCC). Objective response (OR) will defined as the number of lesions with either a complete response (CR) or a partial response (PR) among all eligible and treated lesions, any time within 10 weeks. * Complete Response (CR) = Disappearance of target lesion * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesion * Overall Response (OR) = CR + PR
2 secondary outcomes
Adverse Events Contributing to Treatment Discontinuation or Interruption
Time frame: 8 weeks
Participants Who Discontinued Treatment or Had Treatment Interruption
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kavita Y Sarin, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remetinostat in people with Squamous Cell Carcinoma, run by Kavita Sarin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response (OR) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.