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

Sponsors and Collaborators:	Hana Biosciences, Inc Camargo Pharmaceutical Services
Information provided by:	Hana Biosciences, Inc
ClinicalTrials.gov Identifier:	NCT00656786

Purpose

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.

Condition	Intervention	Phase
EGFRI-Associated Rash	Drug: Menadione	Phase I

MedlinePlus related topics: Cancer Rashes

Drug Information available for: Epidermal Growth Factor Menadione sodium bisulfite Vitamin K 3

U.S. FDA Resources

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

Further study details as provided by Hana Biosciences, Inc:

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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the safety of menadione as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental 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.	Drug: Menadione Menadione will be applied topically twice a day; beginning when the rash appears during EGFRI therapy.
Group 2: Experimental Subjects will receive pre-emergent rash treatment starting 1 day prior to beginning EGFRI therapy	Drug: Menadione Menadione will be applied topically twice a day, starting 1 day before EGFRI therapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656786

Contacts

Contact: Jason Lindow	650-228-5038	jason.lindow@hanabiosciences.com
Contact: Jeannie Fontanilla	650-588-6066	jeannie.fontanilla@hanabiosciences.com

Locations

United States, Illinois
Robert H. Lurie Cancer Center, Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Canada, Quebec
McGill University	Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Penny Chipman 514-398-1444

Sponsors and Collaborators

Hana Biosciences, Inc

Camargo Pharmaceutical Services

Investigators

Principal Investigator:	Mario Lacouture, MD	Robert H. Lurie Cancer Center, Northwestern University
Principal Investigator:	Vera Hirsh, MD	McGill University

More Information

Responsible Party:	Hana Biosciences ( S. Michael Imperiale, MD, VP Clinical Research Operations )
Study ID Numbers:	HBS701
Study First Received:	April 7, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00656786
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada Therapeutic Products Directorate

Study placed in the following topic categories:

Exanthema
Antiplasmin
Vitamin K 3
Skin Diseases
Vitamin K

Additional relevant MeSH terms:

Fibrin Modulating Agents
Antifibrinolytic Agents
Coagulants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents
Micronutrients
Hemostatics
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009