This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premal… (NCT03939364) | Clinical Trial Compass
WithdrawnPhase 1
This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant Lesions
Stopped: Delays due to manufacturing and the COVID-19 pandemic
United States0Started 2022-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentages of patients with overall response will be summarized by treatment
Timeframe: 13 weeks
2
The percentages of patients reporting any treatment-emergent adverse event (AE) will be tabulated by system organ class and preferred term for each treatment
. 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.
. 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:
Exclusion criteria
. 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).
. 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