A Phase 2, Single-Arm, Open-Label, Single Center Study to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects With Superficial Basal Cell Carcinoma (sBCC) on the Neck, Trunk, or Extremities (Excluding Axilla, Anogenital, and Face/Scalp)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Complete clearance rate of sBCC lesion
研究概览
简要总结
This is a Phase 2, Single-Arm, Open-Label, Single Center, Proof of Concept Study to Assess Efficacy and Safety of Tirbanibulin Ointment 1% in Adult Subjects with superficial basal cell carcinoma (sBCC) on the neck, trunk, or extremities (excluding, axilla, anogenital, and face/scalp).
详细描述
Eligible subject should have one naïve superficial basal cell carcinoma (sBCC) that will be included in the study. sBCC lesion included in the study will initially be confirmed by biopsy (either shave or punch), such that the amount of lesion remaining is at least 25% of the initial lesion surface area, and the initial lesion is at least 6mm in diameter and no more than 20mm in diameter. The total surface area of all treatment area must be <25cm squared. To minimize the burden of the subject, biopsies (either shave or punch) taken within 6 months prior to screening can be considered.
The treatment area (visible sBCC with 5mm margin of normal skin) will be marked with indelible marker (e.g., surgical marker) at Screening/Baseline (Day 1 pre-dose) at the investigational site. Lesion marking should be applied about 3~4mm from the sBCC. This will be transferred to an acetate sheet with 3 anatomical landmarks marked, Subject number, and location as well.
Approximately 10 subjects who meet the study criteria will be enrolled. The study consists of Screening, Treatment, LSR and Response Assessment and Excision Period, Suture Removal, and Follow Up. After a Screening Period of up to 29 days, subjects will return to the site for confirmation of eligibility. Eligible subjects will be randomized on Day 1 to treatment course 1 for a 5 consecutive day treatment course.
Subjects will return to the clinical site for LSR assessment, Visit 3, on day 8 and at the Response Assessment or Possible Excision, Visit 4, on day 26. If lesion is assessed as resolved, excision will be performed, Suture Removal, Visit 5, at day 36, and Follow Up, visit 6, on day 54. If lesion is assessed as not resolved at Visit 4, subjects will then proceed to Treatment Course 2 for another 5 consecutive days. For subjects who completed Treatment Course 2, subjects will return to the clinical site for LSR assessment, Visit 4a, on day 33, Response Assessment and Excision, Visit 4b, on day 51, Suture Removal, Visit 5, on day 61, and Follow Up, Visit 6, on day 79 .
The duration of the entire study from first subject, first visit to last subject, last visit is anticipated to be approximately 9 months. For the Screening, Treatment, LSR and Response Assessment and Excision Periods, Suture Removal, and Follow Up Period each subject will participate for up to 80 days:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 18 years old.
- •Willingness and ability to sign the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent form and a HIPAA form must be obtained in writing for all subjects prior to starting any study procedures.
- •Present of 1 naïve sBCC on the neck, trunk, or extremities (excluding, axilla, anogenital, and face/scalp) that:
- •is between 6 and 20mm in greatest diameter
- •>2cm from a hairline
- •Must lack any evidence of aggressive growth patterns (e.g., severe squamous metaplasia, infiltrative/desmoplastic features, or basosquamous features)
- •sBCC assessed as non-naïve (e.g., previously treated, or recurrent) or non-eligible by biopsy and at least 5cm away from an eligible lesion should be excised or treated with Electrodesiccation and Curettage (ED&C) in a timely manner.
- •Free of significant physical abnormalities (e.g., tattoos, dermatoses) within the potential treatment area plus a 5cm radius surrounding the lesion as they may interfere with examination or final evaluation, in the opinion of the investigator.
- •Willingness to stop the use of moisturizers, sunscreens, and any other cosmetics within the treatment area plus a 5cm radius from screening until final the visit.
- •Willingness to abstain from sunbathing or the use of artificial tanning from screening until the final visit. Subjects with a sunburn in the treatment area cannot be included until fully recovered.
- •Subjects must be healthy or have a medical condition that is stable in the opinion of the investigator.
- •Females must be postmenopausal (>45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of childbearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device, or complete abstinence from sexual intercourse.
- •Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment.
排除标准
- •Location of the treatment area is:
- •On face, scalp, anogenital, axillae
- •Within 5 cm of an incompletely healed wound
- •Within 2 cm of hairline
- •Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day
- •Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for Actinic Keratosis (AK) within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening visit.
- •Use of the following therapies and/or medications within 2 weeks prior to the Screening visit:
- •Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area
- •Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area
- •Topical salves or topical steroids within the treatment area or within 2 cm of the selected treatment area
- •Artificial tanners within the treatment area or within 5 cm of the selected treatment area
- •Use of the following therapies and/or medications within 4 weeks prior to the Screening visit:
- •Treatment with immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon inducers
- •Treatment with systemic medications that suppress the immune system (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab)
- •Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit
- •A history of sensitivity and/or allergy to any of the ingredients in the study medication.
- •A skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the subject to unacceptable risk by study participation.
- •Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the subject to unacceptable risk by study participation.
- •Females who are pregnant or nursing.
- •Participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
- •In the opinion of the investigator, are unable or unlikely to comply with the administration schedule and study evaluations.
研究组 & 干预措施
5 Day treatment course 1 with Tirbanibulin Ointment 1%
10 Subjects will be given one study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.
干预措施: Tirbanibulin Ointment 1% (Drug)
5 Day treatment course 2 with Tirbanibulin Ointment 1%
Subjects with unresolved lesion will be given an additional study kit containing single-dose packets of Tirbanibulin Ointment 1% and instructed to topically apply to the treatment area once daily for 5 consecutive days.
干预措施: Tirbanibulin Ointment 1% (Drug)
结局指标
主要结局
Complete clearance rate of sBCC lesion
时间窗: 26 days for subjects who completed 1 course of treatment and 51 days for subjects who completed 2 courses of treatment
The primary efficacy endpoint will be the percent of subjects with both clinical and pathological clearance of sBCC lesion for subjects who completed 1 course of treatment and subjects who completed 2 courses of treatment.
次要结局
未报告次要终点