Leukoplakia, OralPhase 1NCT03939364

This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant Lesions

A Phase 1 study testing SBS-101 in people with Leukoplakia, Oral, run by Skyline Biosciences at 5 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study will be the first study investigating the safety, pharmacokinetics (PK), and efficacy of SBS-101 on oral pre-malignant lesions. As such, no clinical data has yet been generated using SBS-101 oral adhesive film. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Leukoplakia, Oral
What is being tested?: SBS-101
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 5 sitesUnited States
Study dates: Jan 2022to May 2023
Phase: Phase 1
Are there results?: None posted in the registry

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

Patient is able to comprehend and willing to sign an Informed Consent Form.
Patient is willing and able to follow all study instructions and to attend all study visits
Patient is male or female aged 18 years or older at Screening.
Patient has oral leukoplakia or erythroplakia at least 5mm in length on its longest axis with histopathology showing mild, moderate, or severe dysplasia (index lesion histology score of ≥2) with incisional (punch) biopsy at Screening (or within 30 days prior to Screening).
Patient agrees to not use any topical therapies (i.e. use of over the counter and medically prescribed topical creams, ointments, or oral rinses) on the index lesion other than the study drug that, in the Investigator's opinion, might influence the status of the index lesion for the duration of the study.
Patient agrees to not apply any other topical products or use potential irritants (i.e. alcohol containing mouthwash) to the oral premalignant lesions throughout the study. Note: mouthwash that includes non-alcohol containing formulations of Listerine and Crest is acceptable to use during the study.

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If female, patient is non-pregnant, non-lactating and is not planning for pregnancy during the study period or for 1 month after the last dose of study drug.
Female patients of non-childbearing potential must meet the following requirements:
Pre-menopausal with documentation of surgical sterilization (i.e., hysterectomy, bilateral tubal ligation, bilateral oophorectomy, or bilateral salpingectomy) at least 3 months prior to study entry.
Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle-stimulating hormone (FSH) level ≥40 milli-international units per milliliter (mIU/mL) at Screening.
Female patients of child-bearing potential must select and commit to use 2 forms of effective contraception simultaneously, at least 1 of which must be a primary form, unless absolute abstinence is the chosen method, or the patient has undergone a hysterectomy. Patients must use 2 forms of effective contraception at least 1 month prior to study initiation (Screening), during the study, and for 1 month after the final dose of study drug.
Primary (hormonal or surgical)
Tubal ligation
Partner's vasectomy
Intrauterine devices
Birth control pills
Injectable/implantable/insertable hormonal birth control products Secondary (Barrier Method)
Diaphragm (with spermicide)
Cervical cap (with spermicide)
Male condom (with spermicide)
Male patients must agree to use condoms during sexual intercourse during the study and for 3 months after the final dose of study drug. If a female partner is of childbearing potential, she should use contraception as detailed in Inclusion criterion
# 9. Males must also agree to not donate sperm from the time of first dosing and for 3 months after the final dose of study drug.
Patient's Eastern Cooperative Oncology Group (ECOG) performance status grade is 0 or 1 at Screening.
Patient's organ function is determined to be adequate based on laboratory testing at Screening (e.g. Hemoglobin levels ≥ 10g/dl; White Blood Cells (WBC) ≥ 3,000/μL; Platelets ≥ 100,000/μL; Total bilirubin ≤ 1.5x Upper Limit of Normal (ULN); Aspartate Aminotransferase (AST)/ Alanine aminotransferase (ALT) < 2x Upper Limit of Normal (ULN);, Blood urea nitrogen (BUN) \& serum creatinine ≤ 1.5x Upper Limit of Normal (ULN); Lactate dehydrogenase (LDH) ≤ 1.5x Upper Limit of Normal (ULN); Glucose < 200 mg/dL; Thyroid Stimulating Hormone (TSH) ≤ 5.0 μU/mL; C-Reactive Protein < 5.0 mg/L).
Negative urine drug screen at Screening.
Patient is in good general health and free of any known disease state or physical condition which, in the Investigator's opinion, might impair evaluation of the oral premalignant lesions or which exposes the patient to an unacceptable risk by participating in the study.

Who cannot join

Patient has oral lesions to be treated that are infected (e.g. lesions that require local or systemic antimicrobial, antifungal, or antiviral therapy to treat an infection) within 14 days of Randomization.
Patients must not use any systemic (e.g., oral or injectable) corticosteroid therapy during the study or within 30 days prior to Screening. However, use of topical, inhaled, ophthalmic, intraarticular and intralesional steroids is permitted.
Patient has used any topical or systemic chemotherapeutic product within 30 days prior to Randomization.
Use of smokeless tobacco within 4 weeks prior to Screening or during the course of the study.
Patient has been diagnosed with hairy leukoplakia.
Patient has evidence of a systemic infection or has used systemic antibiotics within 14 days prior to start of dosing for males and females of non-childbearing potential or within 30 days prior to start of dosing for Women of Childbearing Potential (WOCBP).

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Patient is currently taking high doses of vitamin A (> 25,000 USP units per day) or has previously used isotretinoin for the treatment of another condition within 6 months of Screening.
Patient is currently taking phenytoin or other prohibited medication
Patient's index lesion is a recurrent dysplastic lesion in a previously treated area for oral cancer (previous treatment, bed/excision, etc.).
The patient has received radiation or chemoradiation therapy to oral cavity within 2 years of Randomization.
The patient has any immune compromising conditions at Screening (i.e. HIV, SLE, etc.) or has been treated with immunomodulating medications within 6 months of Screening.
Patient currently has poorly controlled diabetes mellitus (uninterrupted hemoglobin A1c >9% for ≥1 year despite standard care).
Patient has a history of cardiac, hepatic (ALT and or AST >2x ULN, Total bilirubin >1.5x ULN at Visit 1), or renal disease (eGFR<45 ml/min/1.73 m2) that, in the opinion of the Investigator, might put the patient at undue risk by participating in the study or interferes with the study drug application or the study assessments.
Patient has a history of sensitivity to any of the active ingredients in the study drug (e.g. isotretinoin, propylene glycol, natural mint), or retinoids, or vitamin A.
Patient has used oral isotretinoin within 14 days of Screening. Patients must agree to abstain from using oral isotretinoin throughout the duration in the study.
Patient has participated in an investigational drug trial in which administration of an investigational study drug occurred within 30 days prior to Randomization.
Patient is, in the opinion of the Investigator, not an appropriate candidate for study participation.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC)
Birmingham, Alabama, 35233
Brigham and Women's Hospital
Boston, Massachusetts, 02120
Carolinas Center for Oral Health
Charlotte, North Carolina, 28209
University of Texas Southwestern Medical Center - Oral & Maxillofacial Surgery Clinic
Dallas, Texas, 75390
PennState Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of SBS-101 After Intraoral Application in Patients With Oral Premalignant Lesions (OPL)

Conditions: Leukoplakia, Oral
Being tested: SBS-101, Placebo
Keywords: Erythroplakia, oral, Erythro-leukoplakia, oral
Medical subject headings: Leukoplakia, Oral, Erythroplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SBS-101Drug
Isotretinoin Oral-Adhesive Film
PlaceboDrug
Placebo

Study groups in NCT03939364
Study group	Role	What they receive
0.1% SBS-101	Experimental	Not described Receives: Drug: SBS-101
0.3% SBS-101	Experimental	Not described Receives: Drug: SBS-101
0.2% SBS-101	Experimental	Not described Receives: Drug: SBS-101
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentages of patients with overall response will be summarized by treatment
Overall response is defined as complete or partial response in either clinical or histological outcome without worsening of either.
Measured: 13 weeks
The percentages of patients reporting any treatment-emergent adverse event (AE) will be tabulated by system organ class and preferred term for each treatment
Measured: 13 weeks

Secondary outcomes (1)

Plasma concentrations of isotretinoin will be summarized by treatment using descriptive statistics
Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2022May 2023

First posted6 May 2019
Study startJan 2022 (estimated)
Primary completionApr 2023 (estimated)
Study completionMay 2023 (estimated)

Why it stopped: Delays due to manufacturing and the COVID-19 pandemic

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Leukoplakia, OralStudies 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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03939364
Sponsor's protocol ID: SBS-101-CL-001
Status last verified: Oct 2021
First submitted: 18 Apr 2019
Last updated: 19 Oct 2021
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Active, not recruitingPhase 2
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
Erythroplakia, Oral Leukoplakia
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
RecruitingPhase 2
Pembrolizumab in Treating Participants With Leukoplakia
Erythroleukoplakia, Leukoplakia
RecruitingPhase 2
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Oral Leukoplakia

All Leukoplakia, Oral trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of SBS-101 After Intraoral Application in Patients With Oral Premalignant Lesions (OPL)
ClinicalTrials.gov ID: NCT03939364
Acronym / sponsor ID: SBS-101-CL-001
Conditions: Leukoplakia, Oral
Keywords: Erythroplakia, oral, Erythro-leukoplakia, oral
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Delays due to manufacturing and the COVID-19 pandemic
Enrolment: 0 participants (actual)
Lead sponsor: Skyline BiosciencesIndustry (pharma, biotech, devices)
Study start: Jan 2022 (estimated)
Primary completion: Apr 2023 (estimated)
Study completion: May 2023 (estimated)
First posted: 6 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
0.1% SBS-101	Experimental	Drug: SBS-101
0.3% SBS-101	Experimental	Drug: SBS-101
0.2% SBS-101	Experimental	Drug: SBS-101
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (27 listed)

Patient is able to comprehend and willing to sign an Informed Consent Form.
Patient is willing and able to follow all study instructions and to attend all study visits
Patient is male or female aged 18 years or older at Screening.
Patient has oral leukoplakia or erythroplakia at least 5mm in length on its longest axis with histopathology showing mild, moderate, or severe dysplasia (index lesion histology score of ≥2) with incisional (punch) biopsy at Screening (or within 30 days prior to Screening).
Patient agrees to not use any topical therapies (i.e. use of over the counter and medically prescribed topical creams, ointments, or oral rinses) on the index lesion other than the study drug that, in the Investigator's opinion, might influence the status of the index lesion for the duration of the study.

Key exclusion criteria (17 listed)

Patient has oral lesions to be treated that are infected (e.g. lesions that require local or systemic antimicrobial, antifungal, or antiviral therapy to treat an infection) within 14 days of Randomization.
Patients must not use any systemic (e.g., oral or injectable) corticosteroid therapy during the study or within 30 days prior to Screening. However, use of topical, inhaled, ophthalmic, intraarticular and intralesional steroids is permitted.
Patient has used any topical or systemic chemotherapeutic product within 30 days prior to Randomization.
Use of smokeless tobacco within 4 weeks prior to Screening or during the course of the study.
Patient has been diagnosed with hairy leukoplakia.

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
SBS-101Isotretinoin Oral-Adhesive Film	Drug	0.1% SBS-101, 0.2% SBS-101, 0.3% SBS-101
PlaceboPlacebo	Drug	Placebo

Primary outcome

Percentages of patients with overall response will be summarized by treatment
Time frame: 13 weeks
Overall response is defined as complete or partial response in either clinical or histological outcome without worsening of either.
The percentages of patients reporting any treatment-emergent adverse event (AE) will be tabulated by system organ class and preferred term for each treatment
Time frame: 13 weeks

1 secondary outcome

Plasma concentrations of isotretinoin will be summarized by treatment using descriptive statistics
Time frame: 13 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.

Related trials for Leukoplakia, Oral

RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Active, not recruitingPhase 2
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
Erythroplakia, Oral Leukoplakia
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
RecruitingPhase 2
Pembrolizumab in Treating Participants With Leukoplakia
Erythroleukoplakia, Leukoplakia
RecruitingPhase 2
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Oral Leukoplakia

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.

Joy Schleyer study director

Skyline Biosciences

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SBS-101 in people with Leukoplakia, Oral, run by Skyline Biosciences at 5 sites 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 27 inclusion and 17 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: withdrawn, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Percentages of patients with overall response will be summarized by treatment (time frame: 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03939364.

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 19 Oct 2021.