EGFRI Induced Acneiform LesionsPhase 2NCT04759664
LUT014 for the Reduction of Dose-Limiting Acneiform Lesions Associated With EGFRI Treatment of mCRC
A Phase 2 study testing LUT014 Gel (Dose 1) and LUT014 Gel (Dose 2) in people with EGFRI Induced Acneiform Lesions, run by Lutris Pharma Ltd. at 20 sites in 2 countries.
Trial summary
The study evaluates the efficacy and safety of two strengths of LUT014 Gel topically applied once a day for 4 weeks, compared to placebo, in metastatic colorectal cancer (mCRC) patients who developed Grade 2 or non-infected Grade 3 EGFRI induced acneiform lesions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFRI Induced Acneiform Lesions
- What is being tested?
- LUT014 Gel (Dose 1) and LUT014 Gel (Dose 2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 12 Apr 2021to May 2024
- Phase
- Phase 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with mCRC;
- Currently being treated with an FDA approved monoclonal antibody EGFRI for the treatment of mCRC, including but not limited to Erbitux® (cetuximab) Injection and Vectibix® (panitumumab) Injection, as directed by the approved labeling;
- Grade 2 or Grade 3 non-infected acneiform lesions at the Screening and Baseline;
- A reversed score of no more than 44 for the skin-specific questions (first 13 questions) of the FACT-EGFRI-18 HRQoL questionnaire at the Screening and Baseline;
- Age ≥18 years at the time of signing the informed consent form (ICF);
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2;
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- Expected life expectancy greater than 3 months;
- Subject can understand and sign the ICF, can communicate with the Investigator, can understand and comply with the requirements of the protocol, and can apply the study drug by himself/herself or has a care giver that can apply the drug;
- Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 0);
Who cannot join
- Active infection within the treatment area or in other body areas that requires initiation of systemic antibiotics ;
- Significant skin disease other than EGFRI induced acneiform lesions within the same body areas planned for study drug application;
- Has a beard that would interfere with administration of study drug and assessment of study endpoints (scoring of lesions);
- Any cancer other than mCRC within 3 years of Screening, except for carcinoma in situ of the cervix;
- Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study;
- Clinically relevant serious co-morbid medical conditions including, but not limited to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active central nervous system (CNS) disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements;
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- Pregnant or lactating;
- Treatment with an EGFRI other than the FDA approved monoclonal antibody EGFRI for the treatment of mCRC within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
- 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. Patients whose mCRC is being treated with a monoclonal antibody EGFRI in combination with a B-Raf inhibitor, such as Erbitux® (cetuximab) Injection in combination with Braftovi® (encorafenib) Capsules, will not be eligible to participate in this trial;
- Treatment with a systemic corticosteroid 14 days prior to Baseline or treatment with a topical corticosteroid to the face, neck, or upper portion of the anterior or posterior chest within 7 days prior to Baseline (Day 0). Patients receiving systemic corticosteroids for 24 hours or less only at the time of chemotherapy infusions (for the prevention or treatment of chemotherapy-induced nausea and vomiting) will be allowed to enroll into this study;
- Treatment with a topical antibiotic to the face, neck, or upper portion of the anterior or posterior chest within 7 days prior to Baseline (Day 0);
- Initiation of treatment with systemic antibiotic(s) < 28 days prior to Baseline (Day 0) or any change in dose or frequency of systemic antibiotic(s) within 28 days prior to Baseline. Patients that undergo a washout from systemic antibiotic(s) will be allowed to participate in this trial as long as no systemic antibiotics are taken within 7 days prior to Baseline and they meet all other eligibility criteria;
- Treatment with any other topical medication applied to the face, neck, or upper portion of the anterior or posterior chest within 7 days prior to Baseline (Day 0).
- Treatment with an oral retinoid within 30 days or 5 half-lives of the drug prior to Baseline (Day 0), whichever is longer. Patients that undergo a washout from oral retinoids will be allowed to participate
- Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer;
- Known hypersensitivity to the inactive ingredients of the study drug (active or placebo).
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States17 sites, 17 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Nicole LeBoeuf, MD, 617-732-4918
Harita_Dharaneeswaran@dfci.harvard.edu
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Alexander Starodub, MD, 513-585-1140
abby.reed@thechristhospital.com
- Not yet recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Meng Zhao, MD, 425-297-5531
roberta.lantzy@providence.org
- Recruiting
Innovative Clinical Research Institute
Glendale, California, 91204
John Khoury, MD, 562-693-4477
KirstenBettino@theoncologyinstitute.com
- Recruiting
Appalachian Regional Healthcare
Hazard, Kentucky, 41701
Samuel Bailey, MD, 606-435-7202
tmcdaniel@arh.org
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Anisha Patel, MD, 713-745-1113
jvleong@mdanderson.org
- Recruiting
Miami Dermatology & Laser Research
Miami, Florida, 33173
Nicole Reith, 305-279-6060
andream@miamidermlaser.com
- Recruiting
Miami Dermatology and Laser Institute
Miami, Florida, 33173
Jill Waibel, MD, 305-279-6060
odalysf@miamidermlaser.com
- Recruiting
Hackensack Meridian Health
Neptune City, New Jersey, 07753
David Greenberg, MD, 732-776-3301
denise.theiler@hmhn.org
- Recruiting
Memorial Sloane Kettering
New York, New York, 10065
Mario Lacouture, MD, 646-608-2337
KetosugK@mskcc.org
- Recruiting
New York Cancer and Blood Specialists
New York, New York, 11776
Richard Zuniga, 855-528-7322
LCoolbaugh@nycancer.com
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Efrat Dotan, MD, 888-369-2427
katrina.bynum@fccc.edu
- Recruiting
UPMC Hillman Cancer Center Investigational Drug Service
Pittsburgh, Pennsylvania, 15232
Janie Zhang, MD, 412-623-4891
chrostowskim@upmc.edu
- Recruiting
UCLA
Santa Monica, California, 90404
Zev Wainberg, MD, 310-633-8400
bcherian@mednet.ucla.edu
- Recruiting
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103
Anil Veluvolu, MD, 318-212-8671
fturner@wkhs.com
- Recruiting
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405
Abishek Marballi, MD, 253-403-1677
Samantha.Blake@multicare.org
- Recruiting
Moffit Cancer Center
Tampa, Florida, 33637
Iman Imanirad, 813-745-4673
o'neke.nickle@moffitt.org
Israel3 sites, 3 recruiting
- Recruiting
Assuta Ashdod
Ashdod
Larisa Ryvo, MD, 972-72-3398279
lironmao@assuta.co.il
- Recruiting
E. Wolfson Medical Center
Holon
Ina Sarel, 97235028813, inasa@wmc.gov.il
- Recruiting
Shaara Zedek Medical Center
Jerusalem
Ofer Purim, 972-2-6555361
shirlyad@szmc.org.il
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Topically Administered LUT014 in Metastatic Colorectal Cancer Patients With EGFR Inhibitor Induced Acneiform Lesions
The study evaluates the efficacy and safety of two strengths of LUT014 Gel topically applied once a day for 4 weeks, compared to placebo, in metastatic colorectal cancer (mCRC) patients who developed Grade 2 or non-infected Grade 3 EGFRI induced acneiform lesions
- Conditions
- EGFRI Induced Acneiform Lesions
- Being tested
- LUT014 Gel (Dose 1), LUT014 Gel (Dose 2), Placebo
- Keywords
- EGFRI, Acneiform, Acneiform lesions, Acneiform rash, EGFRI induced skin toxicities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUT014 Gel (Dose 1)Drug
Topical gel
LUT014 Gel (Dose 2)Drug
Topical gel
PlaceboDrug
LUT014 matching placebo topical gel
| Study group | Role | What they receive |
|---|---|---|
| LUT014 Gel (Dose 1) | Experimental | Not described Receives: Drug: LUT014 Gel (Dose 1) |
| LUT014 Gel (Dose 2) | Experimental | Not described Receives: Drug: LUT014 Gel (Dose 2) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects in each treatment group who reached treatment success
Treatment success will be defined as an improvement (decrease) of at least one grade in the severity of the acneiform lesions from baseline to Day 28, based on CTCAE V5.0 skin and subcutaneous tissue disorders grading scale OR an improvement (increase) of at least 5 points in the total score for the skin-specific (first 13 questions) of the FACT-EGFRI-18 HRQoL questionnaire, from baseline to Day 28, with the exception of subjects who:
- their dose of EGFRI was decreased, delayed, or stopped during the RDPBC treatment period
- initiated treatment with topical or systemic antibiotic(s) for the treatment of their acneiform lesions during the RDPBC treatment period
- experience an increase in the dose or frequency of the systemic antibiotic(s) relative to Baseline during the RDPBC treatment period
- are discontinued from study drug (active or placebo) during the RDBPC treatment period due to worsening of their acneiform lesions
Measured: Four weeks (28 days)
Secondary outcomes (5)
Change in the severity of acneiform lesions based on CTCAE grading scale from baseline to Days 7, 14, 21, 28, and 55. For subjects enrolled in the OLE, the change from pre-dose Day 28 to Days 35, 42, 49, 56, and 84 will also be evaluated;
Measured: 8-16 weeks (56-84 days)
Change in the FACT-EGFRI-18 questionnaire total score for the skin-specific questions from baseline to Days 7, 14, 21, 28, and 55. For subjects enrolled in the OLE, the change from pre-dose Day 28 to Days 35, 42, 49, 56, and 84 will also be evaluated;
Measured: 8 -16 weeks (56-84 days)
Relative change in the FACT-EGFRI-18 HRQoL questionnaire
Relative change in the FACT-EGFRI-18 score for the skin-specific questions from D0 to D7,14,21,28, 55 compared to the maximal possible improvement in the score from D0; and the relative change from D28 to D35,42,49,56,84 compared to the maximal possible improvement in the score from D28 for OLE subjects.
Measured: 8 weeks (56 days)
Proportion of subjects whose dose of EGFRI was decreased, delayed, or stopped during the RDPBC and the OLE treatment period
Measured: 4 weeks (28 days)
Number of AEs and the number and percentage of subjects with AEs
Measured: 8 weeks (6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start12 Apr 2021
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFRI Induced Acneiform LesionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lutris Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759664
- Sponsor's protocol ID
- L-02-01
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2021
- Last updated
- 6 Oct 2023
- 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 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Topically Administered LUT014 in Metastatic Colorectal Cancer Patients With EGFR Inhibitor Induced Acneiform Lesions
- ClinicalTrials.gov ID
- NCT04759664
- Acronym / sponsor ID
- L-02-01
- Conditions
- EGFRI Induced Acneiform Lesions
- Keywords
- EGFRI, Acneiform, Acneiform lesions, Acneiform rash, EGFRI induced skin toxicities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Lutris Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 18 Feb 2021 (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 evaluates the efficacy and safety of two strengths of LUT014 Gel topically applied once a day for 4 weeks, compared to placebo, in metastatic colorectal cancer (mCRC) patients who developed Grade 2 or non-infected Grade 3 EGFRI induced acneiform lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LUT014 Gel (Dose 1) | Experimental | Drug: LUT014 Gel (Dose 1) |
| LUT014 Gel (Dose 2) | Experimental | Drug: LUT014 Gel (Dose 2) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with mCRC;
- Currently being treated with an FDA approved monoclonal antibody EGFRI for the treatment of mCRC, including but not limited to Erbitux® (cetuximab) Injection and Vectibix® (panitumumab) Injection, as directed by the approved labeling;
- Grade 2 or Grade 3 non-infected acneiform lesions at the Screening and Baseline;
- A reversed score of no more than 44 for the skin-specific questions (first 13 questions) of the FACT-EGFRI-18 HRQoL questionnaire at the Screening and Baseline;
- Age ≥18 years at the time of signing the informed consent form (ICF);
Key exclusion criteria (16 listed)
- Active infection within the treatment area or in other body areas that requires initiation of systemic antibiotics ;
- Significant skin disease other than EGFRI induced acneiform lesions within the same body areas planned for study drug application;
- Has a beard that would interfere with administration of study drug and assessment of study endpoints (scoring of lesions);
- Any cancer other than mCRC within 3 years of Screening, except for carcinoma in situ of the cervix;
- Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study;
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 Gel (Dose 1)Topical gel | Drug | LUT014 Gel (Dose 1) |
| LUT014 Gel (Dose 2)Topical gel | Drug | LUT014 Gel (Dose 2) |
| PlaceboLUT014 matching placebo topical gel | Drug | Placebo |
Primary outcome
The proportion of subjects in each treatment group who reached treatment success
Time frame: Four weeks (28 days)
Treatment success will be defined as an improvement (decrease) of at least one grade in the severity of the acneiform lesions from baseline to Day 28, based on CTCAE V5.0 skin and subcutaneous tissue disorders grading scale OR an improvement (increase) of at least 5 points in the total score for the skin-specific (first 13 questions) of the FACT-EGFRI-18 HRQoL questionnaire, from baseline to Day 28, with the exception of subjects who: 1. their dose of EGFRI was decreased, delayed, or stopped during the RDPBC treatment period 2. initiated treatment with topical or systemic antibiotic(s) for the treatment of their acneiform lesions during the RDPBC treatment period 3. experience an increase in the dose or frequency of the systemic antibiotic(s) relative to Baseline during the RDPBC treatment period 4. are discontinued from study drug (active or placebo) during the RDBPC treatment period due to worsening of their acneiform lesions
5 secondary outcomes
Change in the severity of acneiform lesions based on CTCAE grading scale from baseline to Days 7, 14, 21, 28, and 55. For subjects enrolled in the OLE, the change from pre-dose Day 28 to Days 35, 42, 49, 56, and 84 will also be evaluated;
Time frame: 8-16 weeks (56-84 days)
Change in the FACT-EGFRI-18 questionnaire total score for the skin-specific questions from baseline to Days 7, 14, 21, 28, and 55. For subjects enrolled in the OLE, the change from pre-dose Day 28 to Days 35, 42, 49, 56, and 84 will also be evaluated;
Time frame: 8 -16 weeks (56-84 days)
Relative change in the FACT-EGFRI-18 HRQoL questionnaire
Time frame: 8 weeks (56 days)
Proportion of subjects whose dose of EGFRI was decreased, delayed, or stopped during the RDPBC and the OLE treatment period
Time frame: 4 weeks (28 days)
Number of AEs and the number and percentage of subjects with AEs
Time frame: 8 weeks (6 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LUT014 Gel (Dose 1) and LUT014 Gel (Dose 2) in people with EGFRI Induced Acneiform Lesions, run by Lutris Pharma Ltd. at 20 sites in 2 countries.
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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Israel. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects in each treatment group who reached treatment success (time frame: Four weeks (28 days)). 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 6 Oct 2023.