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Therapeutic Areas: Oncology
Disease Category: Cancer/Chemotherapy

Trial Information

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

This is a clinical research study of an experimental treatment, Menadione Topical Lotion (Menadione). Menadione treatment is experimental and is not approved for public use. This study will compare the study drug lotion to a placebo lotion.

Hana Biosciences, Inc., the company that is developing Menadione, is the sponsor of this study. EGFR inhibitors (EGFRI) 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.

This study is a Phase 1 study. The main purposes of this study are:

• To evaluate skin rash status over time and the systemic absorption of Menadione as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
• Evaluate the efficacy and safety of Menadione as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash

For consideration, you must meet main Eligibility Criteria:

Inclusion Criteria

• Male or female subjects at least 18 years old.
• Have been prescribed an approved EGFRI to treat cancer and expect to begin this treatment within 14 days
• ECOG performance status of 0-2.
• Have a life expectancy of at least 4 months.

Exclusion Criteria

• Undergoing any current treatment for cancer other than the prescribed EGFRI or combination therapy that is currently labeled with EGFRI that would place subject at undue risk.
• The presence of any active disease that could make application site unacceptable for lotion application.
• Prior treatment with any other marketed or investigation EGFRI therapy within 3 months prior to screening.
• Known hypersensitivity to menadione or similar compounds including any of the inactive ingredients.

Linda Casey
Montreal General Hospital
Located in
Montreal, QC
Canada
Phone: 514-934-1934 ext. 44328
EMail: linda.casey@muhc.mcgill.ca

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