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

July 26, 2022 updated by: Lutris Pharma Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Columbus, Georgia, United States, 31901
        • Columbus Regional Research Institute, LLC
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Willis-Knighton Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LUT014 Gel
LUT014 Gel topical application to the dermatitis area qd for 28 days
Drug: LUT014 Gel
Topical application qd for 28 days
Placebo Comparator: Placebo for LUT014 Gel
Drug: Placebo for LUT014 Gel
Matching placebo for qd topical application for 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 1 subjects)
Time Frame: 12 weeks (83 days)
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)
Time Frame: 14 Days
Dermatology Life Quality Index questionnaire
14 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the severity of radiation dermatitis assessed by CTCAE (Part 1 subjects)
Time Frame: 12 weeks (83 days)
CTCAE grading scale for dermatitis radiation
12 weeks (83 days)
Change in the severity of radiation dermatitis assessed by RTOG/EORTC (part 1 subjects)
Time Frame: 12 weeks (83 days)
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
Time Frame: 12 weeks (83 days)
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)
Time Frame: 12 weeks (83 days)
CTCAE grading scale for dermatitis radiation
12 weeks (83 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lutris Pharma Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LUT-RD-02-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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