Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash
Public ClinicalTrials.gov record NCT00656786. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Multi-center, Randomized, Double-Blind, 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00656786
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 18 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2, 2008
- Primary completion
- Dec 29, 2009
- Completion
- Dec 29, 2009
- Last update posted
- Nov 12, 2020
2008 – 2009
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Solano Clinical Research | Vallejo | California | 94589 | — |
| Robert H. Lurie Cancer Center, Northwestern University | Chicago | Illinois | 60611 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Fox Chase Cancer Center | Rockledge | Pennsylvania | 19046 | — |
| The University of Texas, MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00656786, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 12, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00656786 live on ClinicalTrials.gov.