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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Topical
UCLA Health Santa Monica - Cancer Care
Los Angeles, California, United States
Washington University School of Medicine-Dermatology
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
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
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
The scale contains 5 grades from 1 which demonstrates the mild form of the disease up to 5, defined as death.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
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
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
Time frame: Pre-dose through Day 55