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

NCT ID: NCT04261387

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-30
• Study Completion Date: 2022-07-15

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.

Conditions

Radiation Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LUT014 Gel

LUT014 Gel topical application to the dermatitis area qd for 28 days

Group Type: EXPERIMENTAL

LUT014 Gel

Intervention Type: DRUG

Topical application qd for 28 days

Placebo for LUT014 Gel

Group Type: PLACEBO_COMPARATOR

Placebo for LUT014 Gel

Intervention Type: DRUG

Matching placebo for qd topical application for 28 days

Interventions

LUT014 Gel

Topical application qd for 28 days

Intervention Type: DRUG

Placebo for LUT014 Gel

Matching placebo for qd topical application for 28 days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lutris Pharma Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Columbus Regional Research Institute, Llc

Columbus, Georgia, United States

Willis-Knighton Cancer Center

Shreveport, Louisiana, United States

Countries

United States

Other Identifiers

LUT-RD-02-01

Identifier Type: -

Identifier Source: org_study_id