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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03939364
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Skyline Biosciences

Brief 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.

Condition or disease Intervention/treatment Phase
Leukoplakia, Oral Drug: SBS-101 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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)
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.1% SBS-101 Drug: SBS-101
Isotretinoin Oral-Adhesive Film

Experimental: 0.3% SBS-101 Drug: SBS-101
Isotretinoin Oral-Adhesive Film

Experimental: 0.2% SBS-101 Drug: SBS-101
Isotretinoin Oral-Adhesive Film

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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.

  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 [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Plasma concentrations of isotretinoin will be summarized by treatment using descriptive statistics [ Time Frame: 13 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 visits
  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 (Barrier Method)
    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 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.

  11. Patient's Eastern Cooperative Oncology Group (ECOG) performance status grade is 0 or 1 at Screening.
  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 < 5.0 mg/L).
  13. Negative urine drug screen at Screening.
  14. 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.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Patient has used any topical or systemic chemotherapeutic product within 30 days prior to Randomization.
  4. Use of smokeless tobacco within 4 weeks prior to Screening or during the course of the study.
  5. Patient has been diagnosed with hairy leukoplakia.
  6. 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).
  7. 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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939364


Contacts
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Contact: Ashley Pleasants +1 434 989 2851 Ashley.Pleasants@synteract.com

Locations
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United States, Alabama
University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Anthony Morlandt    205-996-2799    amorlandt@uabmc.edu   
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02120
Contact: Herve Sroussi    617-525-6864    hsroussi@bwh.harvard.edu   
United States, North Carolina
Carolinas Center for Oral Health Not yet recruiting
Charlotte, North Carolina, United States, 28209
Contact: Joel Laudenbach    704-355-1494    Joel.Laudenbach@atriumhealth.org   
United States, Pennsylvania
PennState Health Milton S. Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Karen Choi    717-531-8521    kchoi@pennstatehealth.psu.edu   
United States, Texas
University of Texas Southwestern Medical Center - Oral & Maxillofacial Surgery Clinic Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Thomas Schlieve    214-645-3979    Thomas.schlieve@utsouthwestern.edu   
Sponsors and Collaborators
Skyline Biosciences
Investigators
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Study Director: Joy Schleyer Skyline Biosciences

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Responsible Party: Skyline Biosciences
ClinicalTrials.gov Identifier: NCT03939364     History of Changes
Other Study ID Numbers: SBS-101-CL-001
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Skyline Biosciences:
Erythroplakia, oral
Erythro-leukoplakia, oral

Additional relevant MeSH terms:
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Precancerous Conditions
Leukoplakia
Leukoplakia, Oral
Neoplasms
Pathological Conditions, Anatomical
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases