NCT00656786

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

A Phase 1, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Tolerability, and Systemic Absorption of Menadione Topical Lotion as an Emergent and Pre-emergent Treatment for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical research study of an experimental new medication, Menadione Topical Lotion (MTL). The study lotion is experimental and has not been approved for public use. Hana Biosciences, Inc., the company that is developing MTL, is the sponsor of this study. EGFR inhibitors are used to treat non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, breast cancer and head and neck cancer. One of the side effects of EFGR inhibitors is skin toxicities including an acneform skin rash. This study is a Phase 1 study. The main purposes of this study are: * Evaluate the safety and tolerability of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash * Evaluate the systemic absorption and bioavailability of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash It is planned that up to 24 patients undergoing EGFR inhibitor therapy will take part in this study at multiple clinical centers.

Conditions

• EGFR Inhibitor-associated Rash

Interventions

Type	Name	Description
DRUG	Menadione Topical Lotion	Menadione Lotion will be applied topically twice a day; beginning when the rash appears during EGFRi therapy.
DRUG	Menadione Topical Lotion	Menadione Lotion will be applied topically twice a day, starting 1 day before EGFRi therapy.

Timeline

• Start date: 2008-04-03
• Primary completion: 2009-12-30
• Completion: 2009-12-30
• First posted: 2008-04-11
• Last updated: 2020-11-13

Locations

7 sites across 2 countries: United States, Canada