Clinical trial NCT04261387: LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Radiation Dermatitis
Keywords: Radiation dermatitis, dermatitis, breast cancer
Lead sponsor: Lutris Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-07
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Female subjects diagnosed with stage Tis, T0-T3, N0-N2, M0 Breast Cancer;
2. Subject is ≥18 years at the time of signing the informed consent form (ICF);
3. Radiation dermatitis of Grade 2, based on the NCI CTCAE at the Screening and Baseline (D0) visits;
4. Completed fractionated radiation therapy for breast prior to first dose of study drug (Day 0);
5. A score of ≥ 6 reported in the Dermatology Life Quality Index at the Screening and Baseline Visits;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
7. 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;
8. Expected life expectancy greater than 6 months

Exclusion Criteria:

1. Bilateral breast irradiation;
2. Planned internal mammary node irradiation with electrons. Planned photon coverage of internal mammary chain nodes is acceptable for inclusion in this study;
3. Planned partial breast accelerated irradiation;
4. 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;
5. T4 breast cancer or direct skin involvement by breast cancer;
6. Breast implants or underwent breast reconstruction;
7. Any cancer other than breast cancer within 3 years of Screening, except for carcinoma in situ of the cervix;
8. Pregnant or lactating;
9. History of active systemic lupus erythematosus or scleroderma that is believed to increase the risk of developing radiation-induced dermatitis or its severity;
10. Clinically significant co-morbid diseases
11. 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;
12. Treatment with a topical corticosteroid o the irradiated chest area within 14 days prior to Baseline (Day 0).
13. 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);
14. Treatment with any investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer;
15. Known hypersensitivity to any of the inactive ingredients of the study drug.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 1 subjects)
timeFrame: 12 weeks (83 days)
measure: Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire (Part 2 subjects)
timeFrame: 14 Days
Secondary outcomes:
measure: Change in the severity of radiation dermatitis assessed by CTCAE (Part 1 subjects)
timeFrame: 12 weeks (83 days)
measure: Change in the severity of radiation dermatitis assessed by RTOG/EORTC (part 1 subjects)
timeFrame: 12 weeks (83 days)
measure: Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire
timeFrame: 12 weeks (83 days)
measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 2 subjects)
timeFrame: 12 weeks (83 days)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Columbus Regional Research Institute, Llc
state: Georgia
city: Shreveport
country: United States
facility: Willis-Knighton Cancer Center
state: Louisiana
Study officials:
References: