- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03939364
Recruitment Status Not yet recruiting
First Posted May 6, 2019
Last update posted May 8, 2020
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.
|Experimental: 0.1% SBS-101
Isotretinoin Oral-Adhesive Film
|Experimental: 0.2% SBS-101
Isotretinoin Oral-Adhesive Film
|Experimental: 0.3% SBS-101
Isotretinoin Oral-Adhesive Film
|Placebo Comparator: Placebo
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Patient is able to comprehend and willing to sign an Informed Consent Form.
2. Patient is willing and able to follow all study instructions and to attend all study
3. Patient is male or female aged 18 years or older at Screening.
4. 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).
5. 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.
6. 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.
7. 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.
8. Female patients of non-childbearing potential must meet the following requirements:
1. 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.
2. 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.
9. 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)
1. Tubal ligation
2. Partner's vasectomy
3. Intrauterine devices
4. Birth control pills
5. Injectable/implantable/insertable hormonal birth control products Secondary
1. Diaphragm (with spermicide)
2. Cervical cap (with spermicide)
3. Male condom (with spermicide)
10. 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
# 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.
11. Patient's Eastern Cooperative Oncology Group (ECOG) performance status grade is 0 or 1
12. 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 25,000 USP units per day) or
has previously used isotretinoin for the treatment of another condition within 6
months of Screening.
8. Patient is currently taking phenytoin or other prohibited medication
9. Patient's index lesion is a recurrent dysplastic lesion in a previously treated area
for oral cancer (previous treatment, bed/excision, etc.).
10. The patient has received radiation or chemoradiation therapy to oral cavity within 2
years of Randomization.
11. 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.
12. Patient currently has poorly controlled diabetes mellitus (uninterrupted hemoglobin
A1c >9% for ≥1 year despite standard care).
13. 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. 14. 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. 15. 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. 16. Patient has participated in an investigational drug trial in which administration of an investigational study drug occurred within 30 days prior to Randomization. 17. Patient is, in the opinion of the Investigator, not an appropriate candidate for study participation.
Contact: Ashley Pleasants +1 434 989 2851 Ashley.Pleasants@synteract.com
United States, Alabama
University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC)
United States, Massachusetts
Brigham and Women's Hospital
United States, North Carolina
Carolinas Center for Oral Health
United States, Pennsylvania
PennState Health Milton S. Hershey Medical Center
United States, Texas
University of Texas Southwestern Medical Center - Oral & Maxillofacial Surgery Clinic
Study Director: Joy Schleyer Skyline Biosciences