RECRUITING

LUT014 for the Reduction of Dose-Limiting Acneiform Lesions Associated With EGFRI Treatment of mCRC

Conditions

EGFRI Induced Acneiform Lesions EGFRI, Acneiform, Acneiform lesions, Acneiform rash, EGFRI induced skin toxicities

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2021-04-12

Study Completion:2024-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04759664

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Diagnosed with mCRC; 2. 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; 3. Grade 2 or Grade 3 non-infected acneiform lesions at the Screening and Baseline; 4. 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; 5. Age ≥18 years at the time of signing the informed consent form (ICF); 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2; 7. Expected life expectancy greater than 3 months; 8. 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; 9. Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 0);	1. Active infection within the treatment area or in other body areas that requires initiation of systemic antibiotics ; 2. Significant skin disease other than EGFRI induced acneiform lesions within the same body areas planned for study drug application; 3. Has a beard that would interfere with administration of study drug and assessment of study endpoints (scoring of lesions); 4. Any cancer other than mCRC within 3 years of Screening, except for carcinoma in situ of the cervix; 5. Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study; 6. 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; 7. Pregnant or lactating; 8. 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; 9. 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; 10. 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; 11. 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); 12. 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; 13. 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). 14. 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 15. Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer; 16. Known hypersensitivity to the inactive ingredients of the study drug (active or placebo).

Inclusion Criteria

Exclusion Criteria

1. Diagnosed with mCRC;
2. 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;
3. Grade 2 or Grade 3 non-infected acneiform lesions at the Screening and Baseline;
4. 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;
5. Age ≥18 years at the time of signing the informed consent form (ICF);
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2;
7. Expected life expectancy greater than 3 months;
8. 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;
9. Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 0);

1. Active infection within the treatment area or in other body areas that requires initiation of systemic antibiotics ;
2. Significant skin disease other than EGFRI induced acneiform lesions within the same body areas planned for study drug application;
3. Has a beard that would interfere with administration of study drug and assessment of study endpoints (scoring of lesions);
4. Any cancer other than mCRC within 3 years of Screening, except for carcinoma in situ of the cervix;
5. Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study;
6. 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;
7. Pregnant or lactating;
8. 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;
9. 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;
10. 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;
11. 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);
12. 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;
13. 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).
14. 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
15. Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer;
16. Known hypersensitivity to the inactive ingredients of the study drug (active or placebo).

Contacts and Locations

Study Locations (Sites)

Innovative Clinical Research Institute

Glendale, California, 91204

United States

UCLA

Santa Monica, California, 90404

United States

Miami Dermatology & Laser Research

Miami, Florida, 33173

United States

Miami Dermatology and Laser Institute

Miami, Florida, 33173

United States

Moffit Cancer Center

Tampa, Florida, 33637

United States

Appalachian Regional Healthcare

Hazard, Kentucky, 41701

United States

Willis-Knighton Cancer Center

Shreveport, Louisiana, 71103

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Hackensack Meridian Health

Neptune, New Jersey, 07753

United States

Memorial Sloane Kettering

New York, New York, 10065

United States

New York Cancer and Blood Specialists

New York, New York, 11776

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

UPMC Hillman Cancer Center Investigational Drug Service

Pittsburgh, Pennsylvania, 15232

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Providence Regional Cancer Partnership

Everett, Washington, 98201

United States

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405

United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2021-04-12

Study Completion Date2024-05

Study Record Updates

Study Start Date2021-04-12

Study Completion Date2024-05

Terms related to this study

Keywords Provided by Researchers

EGFRI, Acneiform, Acneiform lesions, Acneiform rash, EGFRI induced skin toxicities

Additional Relevant MeSH Terms

EGFRI Induced Acneiform Lesions