Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash

Official Title

A Phase I, Multi-Centre, Randomized, Double-Blind, Parallel, Placebo Controlled Study of the Tolerability and Systemic Absorption of Topical Menadione Lotion as a Pre-Emergent and Emergent Treatment of Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash.

Summary:

This is a clinical research study of an experimental new medication, Menadione Topical Lotion (Menadione). The medication Menadione is experimental and has not been approved for public use. Hana Biosciences, Inc., the company that is developing Menadione, is the sponsor of this study. EGFR inhibitors are used to treat non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer and head and neck cancer. One of the side effects of EFGR inhibitors is skin rash.

Trial Description

Primary Outcome Measures:
  • Evaluate skin rash status and the systemic absorption of menadione as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
Secondary Outcome Measures:
  • Evaluate the safety of menadione as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society