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NCT04515004 · ClinicalTrials.gov registry record · Phase 2
Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer
A Phase 2 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT04515004: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.
NCT04515004 is a Phase 2 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04515004, a Phase 2 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Lung cancer is the leading cause of cancer death in the country, surpassing deaths caused by colorectal, prostate and breast cancers combined. Veterans are at higher risk of lung cancer due to the higher rate of smoking and environmental toxin exposures. The lack of effective therapy for lung cancer provides the impetus to search for alternative, safe, and effective treatment agents to improve treatment strategy against lung cancer, enhance the probability of a cure and reduce recurrence. Based on encouraging preclinical and clinical findings from an early phase I lung cancer prevention study, using a special formulation of a standardized grape seed extract with enhanced absorption called leucoselect phytosome (LP), the purpose of this new CSR\&D Merit Review project is to evaluate the potential usefulness of LP for pre-surgical treatment of early stage lung cancer patients in a phase IIa clinical trial. Findings from this study may set the stage for larger, confirmatory trials in the near future.
Primary Outcome
Defined as no delay in the planned surgery of \>14 days that is possibly related to study medication.
Interventions
- DRUG leucoselect phytosome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-11-20 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 2 |
Why NCT04515004 stopped before completion
NCT04515004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which leucoselect phytosome is the first listed.
NCT04515004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04515004 about?
NCT04515004 is a clinical study titled "Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer". Lung cancer is the leading cause of cancer death in the country, surpassing deaths caused by colorectal, prostate and breast cancers combined. Veterans are at higher risk of lung cancer due to the higher rate of smoking and environmental toxin exposures. The lack of effective therapy for lung cancer...
What is the current status of trial NCT04515004?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2023-11-20. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT04515004?
The interventions under investigation include: leucoselect phytosome (DRUG).
Who is sponsoring clinical trial NCT04515004?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04515004's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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