Official Title: “A Phase 1, Multi-Center, Randomized, Double-Blind, Sequential, 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”

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.

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: Menadione
  • Menadione will be applied topically twice a day; beginning when the rash appears during EGFRI therapy.
• Drug: Menadione
  • Menadione will be applied topically twice a day, starting 1 day before EGFRI therapy.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group 1
  • Subjects will be treated if, after starting treatment with an EGFRI, acute signs and symptoms of rash on the face/neck and/or upper chest that is suspected of being related to the EGFRI treatment, emerge.
• Experimental: Group 2
  • Subjects will receive pre-emergent rash treatment starting 1 day prior to beginning EGFRI therapy

Primary Measures

• Evaluate skin rash status and the systemic absorption of menadione as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
  • Time Frame: 3 weeks
    Safety Issue?: No

Secondary Measures

• Evaluate the safety of menadione as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash
  • Time Frame: 6 weeks
    Safety Issue?: Yes

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 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hana Biosciences, Inc

Overall Clinical Trial Officials and Contacts

Mario Lacouture, MD Principal Investigator Robert H. Lurie Cancer Center, Northwestern University  

Overall Contact: Jason Lindow 650-228-5038 jason.lindow@hanabiosciences.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00656786

Study ID Number: HBS701

ClinicalTrials.gov Identifier: NCT00656786

Health Authority: United States: Food and Drug Administration