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

Status: Recruiting
Phase: Phase 1
Diagnosis: Other Trials
NCT ID: NCT00656786 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

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 toxicites 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.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Jennifer Temel, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

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: - Known or suspected pregnancy for females - 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.
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