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

October 5, 2023 updated by: Lutris Pharma Ltd.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

117

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashdod, Israel
        • Recruiting
        • Assuta Ashdod
        • Contact:
          • Larisa Ryvo, MD
          • Phone Number: 972-72-3398279
        • Contact:
      • H̱olon, Israel
        • Recruiting
        • E. Wolfson Medical Center
        • Contact:
      • Jerusalem, Israel
        • Recruiting
        • Shaara Zedek Medical Center
        • Contact:
          • Ofer Purim
          • Phone Number: 972-2-6555361
        • Contact:
  • United States
    • California
      • Glendale, California, United States, 91204
      • Santa Monica, California, United States, 90404
    • Florida
      • Miami, Florida, United States, 33173
        • Recruiting
        • Miami Dermatology and Laser Institute
        • Contact:
          • Jill Waibel, MD
          • Phone Number: 305-279-6060
        • Contact:
      • Miami, Florida, United States, 33173
        • Recruiting
        • Miami Dermatology & Laser Research
        • Contact:
          • Nicole Reith
          • Phone Number: 305-279-6060
        • Contact:
      • Tampa, Florida, United States, 33637
        • Recruiting
        • Moffit Cancer center
        • Contact:
          • Iman Imanirad
          • Phone Number: 813-745-4673
        • Contact:
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Recruiting
        • Appalachian Regional Healthcare
        • Contact:
          • Samuel Bailey, MD
          • Phone Number: 606-435-7202
        • Contact:
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Willis-Knighton Cancer Center
        • Contact:
          • Anil Veluvolu, MD
          • Phone Number: 318-212-8671
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Recruiting
        • Hackensack Meridian Health
        • Contact:
          • David Greenberg, MD
          • Phone Number: 732-776-3301
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloane Kettering
        • Contact:
          • Mario Lacouture, MD
          • Phone Number: 646-608-2337
        • Contact:
      • New York, New York, United States, 11776
        • Recruiting
        • New York Cancer and Blood Specialists
        • Contact:
          • Richard Zuniga
          • Phone Number: 855-528-7322
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Contact:
          • Efrat Dotan, MD
          • Phone Number: 888-369-2427
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center Investigational Drug Service
        • Contact:
          • Janie Zhang, MD
          • Phone Number: 412-623-4891
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
          • Anisha Patel, MD
          • Phone Number: 713-745-1113
        • Contact:
    • Washington
      • Everett, Washington, United States, 98201
        • Not yet recruiting
        • Providence Regional Cancer Partnership
        • Contact:
          • Meng Zhao, MD
          • Phone Number: 425-297-5531
        • Contact:
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • MultiCare Institute for Research and Innovation
        • Contact:
          • Abishek Marballi, MD
          • Phone Number: 253-403-1677
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion 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);

Exclusion Criteria:

  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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
LUT014 matching placebo topical gel
Experimental: LUT014 Gel (Dose 1)
Drug: LUT014 Gel (Dose 1)
Topical gel
Experimental: LUT014 Gel (Dose 2)
Drug: LUT014 Gel (Dose 2)
Topical gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Four weeks (28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
8 -16 weeks (56-84 days)
Relative change in the FACT-EGFRI-18 HRQoL questionnaire
Time Frame: 8 weeks (56 days)
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.
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)
4 weeks (28 days)
Number of AEs and the number and percentage of subjects with AEs
Time Frame: 8 weeks (6 days)
8 weeks (6 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 14, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-02-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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