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NCT00656786 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash
A Phase 1 study of EGFR Inhibitor-associated Rash, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 7
- Study locations
NCT00656786: Completed Phase 1 study of EGFR Inhibitor-associated Rash, sponsored by Spectrum Pharmaceuticals.
NCT00656786 is a Phase 1 study of EGFR Inhibitor-associated Rash that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656786, a Phase 1 study of EGFR Inhibitor-associated Rash, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 7
- Study locations
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 Studied
Interventions
- DRUG Menadione Topical Lotion
Study Locations (7)
California
- Solano Clinical Research - Vallejo
Illinois
- Robert H. Lurie Cancer Center, Northwestern University - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
Missouri
- Washington University School of Medicine - St Louis
Pennsylvania
- Fox Chase Cancer Center - Rockledge
Texas
- The University of Texas, MD Anderson Cancer Center - Houston
Quebec
- McGill University - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-04-03 |
| Est. Completion | 2009-12-30 |
| Phase | Phase 1 |
What the finished NCT00656786 record still lists
NCT00656786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with EGFR Inhibitor-associated Rash appearing as the primary indexed condition, and to 1 intervention - of which Menadione Topical Lotion is the first listed.
NCT00656786 lists 7 locations in 7 states (California, Illinois, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT00656786 about?
NCT00656786 is a clinical study titled "Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash". 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 ...
What is the current status of trial NCT00656786?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-04-03. Estimated completion is 2009-12-30.
What conditions does trial NCT00656786 study?
This clinical trial studies the following conditions: EGFR Inhibitor-associated Rash.
What interventions are being tested in trial NCT00656786?
The interventions under investigation include: Menadione Topical Lotion (DRUG).
Who is sponsoring clinical trial NCT00656786?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00656786 being conducted?
This trial has 7 study locations across California, Illinois, Massachusetts, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
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