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

NCT00656786 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-11-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Maria Colavincenzo, MD · Robert H. Lurie Cancer Center, Northwestern University

  • Vera Hirsh, MD · McGill University

  • Milan Anadkat, MD · Washington University School of Medicine

  • Serena Mraz, MD · Solano Clinical Research

  • Cliff Perlis, MD · Fox Chase Cancer Center, Rockledge, PA

  • Madeline Duvic, MD · MD Anderson Cancer Center, Houston, TX

  • Jennifer Temel, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-03
Primary Completion
2009-12-30
Completion
2009-12-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00656786 on ClinicalTrials.gov