Radiation DermatitisPhase 1/2NCT04261387
LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
A Phase 1/2 study testing LUT014 Gel in people with Radiation Dermatitis, run by Lutris Pharma Ltd. at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- LUT014 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2021to 15 Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbus Regional Research Institute, Llc
Columbus, Georgia, 31901
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103
About this study
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
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
- Being tested
- LUT014 Gel, Placebo for LUT014 Gel
- Keywords
- Radiation dermatitis, dermatitis, breast cancer
- Medical subject headings
- Radiodermatitis, Dermatitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUT014 GelDrug
Topical application qd for 28 days
Placebo for LUT014 GelDrug
Matching placebo for qd topical application for 28 days
| Study group | Role | What they receive |
|---|---|---|
| LUT014 Gel | Experimental | LUT014 Gel topical application to the dermatitis area qd for 28 days Receives: Drug: LUT014 Gel |
| Placebo for LUT014 Gel | Placebo comparator | Not described Receives: Drug: Placebo for LUT014 Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 1 subjects)
Common Terminology Criteria for Adverse Events Version 5.0
Measured: 12 weeks (83 days)
Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire (Part 2 subjects)
Dermatology Life Quality Index questionnaire
Measured: 14 Days
Secondary outcomes (4)
Change in the severity of radiation dermatitis assessed by CTCAE (Part 1 subjects)
CTCAE grading scale for dermatitis radiation
Measured: 12 weeks (83 days)
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)
Measured: 12 weeks (83 days)
Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire
Dermatology Life Quality Index questionnaire (part 1 subjects)
Measured: 12 weeks (83 days)
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 2 subjects)
CTCAE grading scale for dermatitis radiation
Measured: 12 weeks (83 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start30 Jan 2021
- Primary completion16 Jun 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lutris Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261387
- Sponsor's protocol ID
- LUT-RD-02-01
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04261387
- Acronym / sponsor ID
- LUT-RD-02-01
- Conditions
- Radiation Dermatitis
- Keywords
- Radiation dermatitis, dermatitis, breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Lutris Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUT014 Gel | Experimental | Drug: LUT014 GelLUT014 Gel topical application to the dermatitis area qd for 28 days |
| Placebo for LUT014 Gel | Placebo comparator | Drug: Placebo for LUT014 Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUT014 GelTopical application qd for 28 days | Drug | LUT014 Gel |
| Placebo for LUT014 GelMatching placebo for qd topical application for 28 days | Drug | Placebo for LUT014 Gel |
Primary outcome
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
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
4 secondary outcomes
Change in the severity of radiation dermatitis assessed by CTCAE (Part 1 subjects)
Time frame: 12 weeks (83 days)
Change in the severity of radiation dermatitis assessed by RTOG/EORTC (part 1 subjects)
Time frame: 12 weeks (83 days)
Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire
Time frame: 12 weeks (83 days)
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 2 subjects)
Time frame: 12 weeks (83 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LUT014 Gel in people with Radiation Dermatitis, run by Lutris Pharma Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 1 subjects) (time frame: 12 weeks (83 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.