LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Radiation Dermatitis
In brief
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.
Key facts
- Study ID
- NCT04261387
- Run by
- Lutris Pharma Ltd.
- People needed
- 28
- Starts
- 2021-01-30
- Expected to finish
- 2022-07-15
- Last updated by the study team
- 2022-07-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Columbus Regional Research Institute, Llc — Columbus, Georgia, United States
- Willis-Knighton Cancer Center — Shreveport, Louisiana, United States
Full record on ClinicalTrials.gov
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