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

Radiation Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261387
• Other study ID #: LUT-RD-02-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 30, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: April 2022
• Source: Lutris Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 15, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Drug:
• LUT014 Gel
Topical application qd for 28 days
• Placebo for LUT014 Gel
Matching placebo for qd topical application for 28 days

Locations

Country	Name	City	State
United States	Columbus Regional Research Institute, Llc	Columbus	Georgia
United States	Willis-Knighton Cancer Center	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Lutris Pharma Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in the severity of radiation dermatitis assessed by CTCAE (Part 1 subjects)	CTCAE grading scale for dermatitis radiation	12 weeks (83 days)
Secondary	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)
Secondary	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)
Secondary	Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 2 subjects)	CTCAE grading scale for dermatitis radiation	12 weeks (83 days)