LUT014 for the Reduction of Dose-Limiting Acneiform Lesions Associated With EGFRI Treatment of mCRC (NCT04759664) | Clinical Trial Compass
UnknownPhase 2
LUT014 for the Reduction of Dose-Limiting Acneiform Lesions Associated With EGFRI Treatment of mCRC
United States117 participantsStarted 2021-04-12
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
✓. 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;
Exclusion criteria
✕. 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);
What they're measuring
1
The proportion of subjects in each treatment group who reached treatment success
✕. 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;
✕. 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;