EGFR Inhibitor Induced Acneiform LesionsPhase 1NCT03876106
A Study of LUT014 in Patients With Metastatic Colorectal Cancer With EGFR Inhibitor Induced Acneiform Lesions
A Phase 1 study testing LUT014 in people with EGFR Inhibitor Induced Acneiform Lesions, run by Lutris Pharma Ltd. at 6 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Inhibitor Induced Acneiform Lesions
- What is being tested?
- LUT014
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 21 Aug 2019to 18 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 12 weeks prior to the Screening Visit;
- Grade 1 or 2 acneiform lesions at the Screening and Baseline (Day 0) Visits; A minimum of 3 subjects per dose cohort must have Grade 2 non-infected 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;
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- 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).
Who cannot join
- 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;
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- 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 topical corticosteroid to the face, neck, or upper portion of the anterior or posterior chest within 14 days prior to Screening or treatment with a systemic corticosteroid within 14 days prior to Screening, except for low dose systemic corticosteroids (e.g., 8-20 mg dexamethasone or comparable) given for up to one or two days every two weeks as part of standard of care for the prevention or treatment of chemotherapy-induced nausea and vomiting (CINV) for subjects being treated with FDA-approved EGFRI and chemotherapy combinations for mCRC;
- Treatment with an oral retinoid within 7 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).
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
MD Anderson Cancer Center
Houston, Texas, 77030
UCLA Health Santa Monica - Cancer Care
Los Angeles, California, 90404
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
Washington University School of Medicine-Dermatology
St Louis, Missouri, 63110
Israel2 sites
Rabin Medical Center
Petah Tikva, 4941492
Sheba Medical Center
Ramat Gan, 5266202
About this study
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
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
- Conditions
- EGFR Inhibitor Induced Acneiform Lesions
- Being tested
- LUT014
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUT014Drug
Topical
| Study group | Role | What they receive |
|---|---|---|
| LUT014 dose level 1 | Experimental | LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks. Receives: Drug: LUT014 |
| LUT014 dose level 2 | Experimental | LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks. Receives: Drug: LUT014 |
| LUT014 dose level 3 | Experimental | LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks. Receives: Drug: LUT014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 0 (following administration of the first dose of study drug) through the Day 55
Secondary outcomes (10)
Maximum concentration (Cmax) in plasma after a single administration and after qd administrations for 8 days
Measured: Pre-dose through Day 8
Time to maximum concentration (Tmax) in plasma after a single administration and after qd administrations for 8 days
Measured: Pre-dose through Day 8
Area under the concentration-time curve from time zero to last measurable concentration (AUC0-T)
Measured: Pre-dose through Day 8
Area under the concentration-time cure from time zero extrapolated to infinity (AUC0-∞)
Measured: Pre-dose through Day 8
Plasma elimination half-life (t1/2)
Measured: Pre-dose through Day 8
Plasma clearance (CL)
Measured: Pre-dose through Day 8
Volume of distribution (Vd)
Measured: Pre-dose through Day 8
NCI, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 skin and subcutaneous tissue disorders grading scale performed locally by the Investigator
The scale contains 5 grades from 1 which demonstrates the mild form of the disease up to 5, defined as death.
Measured: Pre-dose through Day 55
MASCC Study Group EGFRI-dermatologic AE grading by central reader based on photographs
Measured: Pre-dose through Day 55
Functional Assessment of Cancer Therapy-EGFRI 18 (FACT-EGFRI-18) on health-related quality of life (HRQoL) questionnaire
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
Measured: Pre-dose through Day 55
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start21 Aug 2019
- Primary completion9 Jul 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Inhibitor Induced Acneiform LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 Dose escalation of LUT014
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lutris Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876106
- Sponsor's protocol ID
- L-01-01
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03876106
- Acronym / sponsor ID
- L-01-01
- Conditions
- EGFR Inhibitor Induced Acneiform Lesions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lutris Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3+3 Dose escalation of LUT014
| Arm | Type | Receives |
|---|---|---|
| LUT014 dose level 1 | Experimental | Drug: LUT014LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks. |
| LUT014 dose level 2 | Experimental | Drug: LUT014LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks. |
| LUT014 dose level 3 | Experimental | Drug: LUT014LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 12 weeks prior to the Screening Visit;
- Grade 1 or 2 acneiform lesions at the Screening and Baseline (Day 0) Visits; A minimum of 3 subjects per dose cohort must have Grade 2 non-infected acneiform lesions at the Screening and Baseline (Day 0) Visits;
- Age ≥18 years at the time of signing the informed consent form (ICF);
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUT014Topical | Drug | LUT014 dose level 1, LUT014 dose level 2, LUT014 dose level 3 |
Primary outcome
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
10 secondary outcomes
Maximum concentration (Cmax) in plasma after a single administration and after qd administrations for 8 days
Time frame: Pre-dose through Day 8
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
Area under the concentration-time curve from time zero to last measurable concentration (AUC0-T)
Time frame: Pre-dose through Day 8
Area under the concentration-time cure from time zero extrapolated to infinity (AUC0-∞)
Time frame: Pre-dose through Day 8
Plasma elimination half-life (t1/2)
Time frame: Pre-dose through Day 8
Plasma clearance (CL)
Time frame: Pre-dose through Day 8
Volume of distribution (Vd)
Time frame: Pre-dose through Day 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
MASCC Study Group EGFRI-dermatologic AE grading by central reader based on photographs
Time frame: Pre-dose through Day 55
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LUT014 in people with EGFR Inhibitor Induced Acneiform Lesions, run by Lutris Pharma Ltd. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.