A Phase II Study of LUT014 in People with Acneiform Rash from Colorectal Cancer Treatment

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Full Title

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

Purpose

Acne-like (acneiform) rash is a very common side effect of drugs called EGFR inhibitors (such as cetuximab and panitumumab) which are used to treat advanced colorectal cancer. Patients develop small, raised bumps that can be tender and itchy. Acneiform rash can impair a patient’s quality of life and sometimes interfere with the use of an EGFR inhibitor. There is no approved treatment for this rash.

In this study, researchers are assessing two different doses of a gel called LUT014 in patients with acneiform rash caused by their treatment for metastatic colorectal cancer. LUT014 may prevent the rash from forming by reversing the chemical process that allows EGFR inhibitors to cause skin problems, thereby promoting healing. Patients in this study will be randomly assigned to receive one of two doses of LUT014 or a placebo (inactive) gel.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have acneiform rash caused by treatment with an EGFR inhibitor for metastatic colorectal cancer.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mario E. Lacouture at 646-608-2337.

Protocol

21-279

Phase

II

Investigator

Co-Investigators