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NCT00462280 · ClinicalTrials.gov registry record · Phase 2
Lovastatin in Treating Patients At High Risk of Melanoma
A Phase 2 study of Precancerous Condition and Stage II Melanoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 3
- Study locations
NCT00462280: Completed Phase 2 study of Precancerous Condition and Stage II Melanoma, sponsored by National Cancer Institute (NCI).
NCT00462280 is a Phase 2 study of Precancerous Condition and Stage II Melanoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 80 participants, below the 617-participant average among 15 other Precancerous Condition trials with a reported enrollment target (87% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00462280, a Phase 2 study of Precancerous Condition and Stage II Melanoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 3
- Study locations
Study Summary
The use of lovastatin may slow disease progression in patients at high risk of melanoma. It is not yet known whether lovastatin is more effective than a placebo in treating patients at high risk of melanoma. This randomized phase II trial studies how well giving lovastatin or placebo works in treating patients at high risk of melanoma.
Primary Outcome
The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.
Conditions Studied
Interventions
- OTHER placebo
- PROCEDURE biopsy
- DRUG lovastatin
- PROCEDURE laboratory biomarker analysis
Study Locations (3)
California
- University of California Medical Center At Irvine-Orange Campus - Orange
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Utah
- Huntsman Cancer Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2007-05 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00462280 record still lists
NCT00462280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 617-participant average among 15 other Precancerous Condition trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with Precancerous Condition appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.
NCT00462280 reports a single indexed study location in California, Florida, Utah.
Frequently Asked Questions
What is clinical trial NCT00462280 about?
NCT00462280 is a clinical study titled "Lovastatin in Treating Patients At High Risk of Melanoma". The use of lovastatin may slow disease progression in patients at high risk of melanoma. It is not yet known whether lovastatin is more effective than a placebo in treating patients at high risk of melanoma. This randomized phase II trial studies how well giving lovastatin or placebo works in treati...
What is the current status of trial NCT00462280?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2007-05. Estimated completion is 2012-02.
What conditions does trial NCT00462280 study?
This clinical trial studies the following conditions: Precancerous Condition, Stage II Melanoma, Stage 0 Melanoma, Stage I Melanoma.
What interventions are being tested in trial NCT00462280?
The interventions under investigation include: placebo (OTHER), biopsy (PROCEDURE), lovastatin (DRUG), laboratory biomarker analysis (PROCEDURE).
Who is sponsoring clinical trial NCT00462280?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00462280 being conducted?
This trial has 3 study locations across California, Florida, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00462280's enrollment target sits among peer trials
80 13th of 15 higher than 3 of 15 other Precancerous Condition trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Precancerous Condition trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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