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A Study of LUT014 in Patients With Metastatic Colorectal Cancer With EGFR Inhibitor Induced Acneiform Lesions

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ClinicalTrials.gov Identifier: NCT03876106
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Lutris Pharma Ltd.

Brief Summary:
The purpose of this phase 1, multicenter study is to evaluate the safety, tolerability and preliminary efficacy of LUT014 in adult metastatic colorectal cancer patients with EGFR Inhibitor induced acneiform lesions

Condition or disease Intervention/treatment Phase
EGFR Inhibitor Induced Acneiform Lesions Drug: LUT014 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 3+3 Dose escalation of LUT014
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose Escalation Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy Study of Topically Administered LUT014 in Metastatic Colorectal Cancer Patients With EGFR Inhibitor Induced Acneiform Lesions
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LUT014 dose level 1
LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks.
Drug: LUT014
Topical

Experimental: LUT014 dose level 2
LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks.
Drug: LUT014
Topical

Experimental: LUT014 dose level 3
LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks.
Drug: LUT014
Topical




Primary Outcome Measures :
  1. Safety and tolerability (maximum tolerated dose, MTD) of LUT014 topically applied qd for 4 weeks in metastatic colorectal cancer (mCRC) patients with epidermal growth factor receptor inhibitor (EGFRI) induced acneiform lesions. [ Time Frame: From Day 0 (following administration of the first dose of study drug) through the Day 55 ]

Secondary Outcome Measures :
  1. Maximum concentration (Cmax) in plasma after a single administration and after qd administrations for 8 days [ Time Frame: Pre-dose through Day 8 ]
  2. Time to maximum concentration (Tmax) in plasma after a single administration and after qd administrations for 8 days [ Time Frame: Pre-dose through Day 8 ]
  3. Area under the concentration-time curve from time zero to last measurable concentration (AUC0-T) [ Time Frame: Pre-dose through Day 8 ]
  4. Area under the concentration-time cure from time zero extrapolated to infinity (AUC0-∞) [ Time Frame: Pre-dose through Day 8 ]
  5. Plasma elimination half-life (t1/2) [ Time Frame: Pre-dose through Day 8 ]
  6. Plasma clearance (CL) [ Time Frame: Pre-dose through Day 8 ]
  7. Volume of distribution (Vd) [ Time Frame: Pre-dose through Day 8 ]
  8. NCI, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 skin and subcutaneous tissue disorders grading scale performed locally by the Investigator [ Time Frame: Pre-dose through Day 55 ]
    The scale contains 5 grades from 1 which demonstrates the mild form of the disease up to 5, defined as death.

  9. MASCC Study Group EGFRI-dermatologic AE grading by central reader based on photographs [ Time Frame: Pre-dose through Day 55 ]
  10. Functional Assessment of Cancer Therapy-EGFRI 18 (FACT-EGFRI-18) on health-related quality of life (HRQoL) questionnaire [ Time Frame: Pre-dose through Day 55 ]
    FACT-EGFRI-18 is a patient-reported outcomes questionnaire developed to assess the effect of EGFRI on health-related quality of life The questionnaire includes 18 questions, each should be graded from 0, not suffering from this side effect at all, up to 4, suffering greatly from this side effect



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with mCRC;
  • Currently being treated with an FDA approved EGFRI for the treatment of mCRC, including but not limited to Erbitux® (cetuximab) Injection and Vectibix® (panitumumab) Injection, as directed by the approved labeling;
  • Treatment with the FDA approved EGFRI initiated within 4 weeks prior to the Screening Visit;
  • Grade 1 or 2 acneiform lesions at the Screening and Baseline (Day 0) Visits;
  • 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;
  • Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at baseline (Day 0);
  • WCBP must agree to abstain from sex or use an adequate method of contraception from the time of informed consent through the Day 55 Visit and for 90 days after the last dose of study drug (LUT014);
  • Males must abstain from sex with WCBP or use an adequate method of contraception from the time of informed consent through the Day 55 Visit and for 90 days after the last dose of study drug (LUT014).

Exclusion Criteria:

  • Active infection;
  • Significant skin disease other than EGFRI induced acneiform lesions;
  • Any cancer other than mCRC within 3 years of Screening;
  • 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 those specified in the inclusion criteria 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), BraftoviTM (encorafenib), and Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
  • Treatment with a systemic antibiotic within 7 days prior to Screening;
  • 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 Screening;
  • 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 (LUT014).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876106


Locations
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United States, Missouri
Washington University School of Medicine-Dermatology Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Mary Tabacchi    314-362-8171    mtabacchi@wustl.edu   
Principal Investigator: Milan J Anadkat, MD         
Sponsors and Collaborators
Lutris Pharma Ltd.

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Responsible Party: Lutris Pharma Ltd.
ClinicalTrials.gov Identifier: NCT03876106     History of Changes
Other Study ID Numbers: L-01-01
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases