A Phase I Study of LUT014 to Treat Acne-like Lesions in Patients with Colorectal Cancer

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Full 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

Purpose

An acne-like (“acneiform”) rash is a side effect of drugs used to treat colorectal cancer, such as the targeted therapies cetuximab and panitumumab. This rash may be itchy or painful, affect quality of life, and interfere with the ability to continue treatment. In this study, researchers want to find the highest dose of the investigational medication LUT014 that can be given safely in patients with colorectal cancer who experience this side effect.

LUT014 is a gel. It contains a chemical that may change the way targeted therapies affect the skin. It could reduce the severity of the rash from getting worse and decrease the severity of a newly appearing rash.

Eligibility

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

  • Patients must have started treatment for metastatic colorectal cancer, such as cetuximab or panitumumab, within 12 weeks of entering the study.
  • Patients must have a mild to moderate acne-like rash.
  • 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 646-888-6014.

Protocol

19-150

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators