NCT04261387已完成1 期
A Two-Part (Open-Label Followed by Randomized, Double-Blind, Placebo-Controlled) Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of Topically Administered LUT014 for the Treatment of Radiation-Induced Dermatitis in Breast Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 1 subjects)
研究概览
简要总结
The study will evaluate the safety, tolerability and efficacy of LUT014 gel topically administered in breast cancer patients who developed radiation dermatitis. Subjects enrolled to part 1 will be enrolled to receive the study treatment (open label treatment) for 28 days and will be followed up for 2 months after the completion of study treatment. Subject in Part 2 will be randomized in 1:1 ratio to receive either the study drug or placebo (double-blind treatment) for qd topical application for 28 days and will be followed up for 2 months after the completion of study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects diagnosed with stage Tis, T0-T3, N0-N2, M0 Breast Cancer;
- •Subject is ≥18 years at the time of signing the informed consent form (ICF);
- •Radiation dermatitis of Grade 2, based on the NCI CTCAE at the Screening and Baseline (D0) visits;
- •Completed fractionated radiation therapy for breast prior to first dose of study drug (Day 0);
- •A score of ≥ 6 reported in the Dermatology Life Quality Index at the Screening and Baseline Visits;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Females of child-bearing potential must have a negative pregnancy test at screening and must agree to use an effective contraception method* or abstain from sex throughout the study until Day 83;
- •Expected life expectancy greater than 6 months
排除标准
- •Bilateral breast irradiation;
- •Planned internal mammary node irradiation with electrons. Planned photon coverage of internal mammary chain nodes is acceptable for inclusion in this study;
- •Planned partial breast accelerated irradiation;
- •Any cutaneous infection or significant skin disease at Screening or Baseline (Day 0) other than the dermatitis in the area(s) irradiated during fractionated radiation therapy;
- •T4 breast cancer or direct skin involvement by breast cancer;
- •Breast implants or underwent breast reconstruction;
- •Any cancer other than breast cancer within 3 years of Screening, except for carcinoma in situ of the cervix;
- •Pregnant or lactating;
- •History of active systemic lupus erythematosus or scleroderma that is believed to increase the risk of developing radiation-induced dermatitis or its severity;
- •Clinically significant co-morbid diseases
- •Treatment with a serine/threonine-protein kinase B-Raf (B-Raf) inhibitor, including but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), Braftovi® (encorafenib), and Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
- •Treatment with a topical corticosteroid o the irradiated chest area within 14 days prior to Baseline (Day 0).
- •Treatment with a systemic corticosteroid within 14 days prior to Baseline (Day 0), except for low dose systemic corticosteroids (e.g., 8-20 mg dexamethasone or comparable) given for up to one or two days every two weeks as part of standard of care for the prevention or treatment of chemotherapy-induced nausea and vomiting (CINV);
- •Treatment with any investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer;
- •Known hypersensitivity to any of the inactive ingredients of the study drug.
研究组 & 干预措施
LUT014 Gel
Experimental
LUT014 Gel topical application to the dermatitis area qd for 28 days
干预措施: LUT014 Gel (Drug)
Placebo for LUT014 Gel
Placebo Comparator
干预措施: Placebo for LUT014 Gel (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 1 subjects)
时间窗: 12 weeks (83 days)
Common Terminology Criteria for Adverse Events Version 5.0
Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire (Part 2 subjects)
时间窗: 14 Days
Dermatology Life Quality Index questionnaire
次要结局
- Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 2 subjects)(12 weeks (83 days))
- Change in the severity of radiation dermatitis assessed by RTOG/EORTC (part 1 subjects)(12 weeks (83 days))
- Change in the severity of radiation dermatitis assessed by CTCAE (Part 1 subjects)(12 weeks (83 days))
- Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire(12 weeks (83 days))
研究者
研究点 (2)
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