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 range18 Years
SexALL
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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.
✓. 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.
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
✕. 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