LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Drug: LUT014 Gel
* Drug: Placebo for LUT014 Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LUT014 Gel<br>LUT014 Gel topical application to the dermatitis area qd for 28 days | Drug: LUT014 Gel<br>* Topical application qd for 28 days<br>|
| Placebo Comparator: Placebo for LUT014 Gel<br> | Drug: Placebo for LUT014 Gel<br>* Matching placebo for qd topical application for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 1 subjects) | Common Terminology Criteria for Adverse Events Version 5.0 | 12 weeks (83 days) | 
| Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire (Part 2 subjects) | Dermatology Life Quality Index questionnaire | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the severity of radiation dermatitis assessed by CTCAE (Part 1 subjects) | CTCAE grading scale for dermatitis radiation | 12 weeks (83 days) | 
| Change in the severity of radiation dermatitis assessed by RTOG/EORTC (part 1 subjects) | Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) | 12 weeks (83 days) | 
| Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire | Dermatology Life Quality Index questionnaire (part 1 subjects) | 12 weeks (83 days) | 
| Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 2 subjects) | CTCAE grading scale for dermatitis radiation | 12 weeks (83 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation dermatitis, dermatitis, breast cancer