The primary objective of the Phase I study is to evaluate the systemic absorption of menadione topical lotion as an emergent and pre-emergent (prophylactic) treatment for Epidermal Growth Factor Receptor Inhibitor (EGFRI) associated rash. Additionally, the study will evaluate the efficacy and safety of menadione topical lotion in both treatment emergent and prophylaxis patients. The Phase I trial is designed to enroll a total of 24 adult subjects who are about to begin treatment with an approved EGFRI for cancer.
Subjects will be divided into two cohorts, run sequentially. The first cohort will consist of subjects who develop the first signs and symptoms of EGFRI-associated rash on the face, neck, and upper chest following the initiation of their cancer treatment. In the second cohort, subjects will receive menadione lotion prophylactically, starting one day prior to beginning their EGFRI therapy. In both cohorts, subjects will serve as their own control and apply menadione lotion on one side of the treatment area and placebo lotion on the other side, in a blinded fashion. Treatment duration will last approximately one month.
The Phase I clinical trial is currently open and enrolling in Chicago, Illinois at Northwestern University’s Feinberg School of Medicine by Dr Mario Lacouture.