Clinical Trial 21945

• Overview

  Study Title:

  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 Protocol

  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 EGFRI induced acneiform lesions.

  Objective:

  Primary Objective: To evaluate the efficacy of two strengths of LUT014 Gel [0.3 mg/g (0.03% weight/weight, w/w) and 1.0 mg/g (0.10% w/w)] topically applied once a day (qd) for 4 weeks in metastatic colorectal cancer (mCRC) patients with epidermal growth factor receptor inhibitor (EGFRI) induced Grade 2 acneiform lesions compared to placebo. Secondary Objective: To evaluate the safety and tolerability of two strengths of LUT014 Gel [0.3 mg/g (0.03% w/w) and 1.0 mg/g (0.10% w/w)] topically applied qd for 4 weeks in mCRC patients with EGFRI induced Grade 2 acneiform lesions compared to placebo.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  LUT014 (); LUT014/PLACEBO (); Placebo ()

• Inclusion Criteria

  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 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;
  • Patient 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);
  • Additional criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Active infection;
  • 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 patient 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;
  • 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 or treatment with a topical corticosteroid to the face, neck, or upper portion of the anterior or posterior chest within 14 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) > 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).

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