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NCT02583269 · ClinicalTrials.gov registry record · Phase 1
Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02583269: Completed Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT02583269 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02583269, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and the best dose of muscadine grape skin extract (MGE) in treating patients with malignancy (tumor or cancer) that has spread to other parts of the body or cannot be removed by surgery. MGE is a nutritional supplement containing an extract of the skin of muscadine grape that has shown anti-cancer activity in laboratory studies and may be able to fight or kill malignant cells.
Primary Outcome
Maximum tolerable dose of muscadine grape extract is defined as the dose level immediately below the dose level that induced a dose-limiting toxicity (DLT) in \>= 2 patients, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0DLT will be assessed by severity of adverse events.
Interventions
- PROCEDURE Quality-of-Life Assessment
- DIAGNOSTIC_TEST Laboratory Biomarker Analysis
- DRUG Muscadine Grape Skin Extract
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-03 |
| Est. Completion | 2023-04-24 |
| Phase | Phase 1 |
What the finished NCT02583269 record still lists
NCT02583269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02583269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02583269 about?
NCT02583269 is a clinical study titled "Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery". This phase I trial studies the side effects and the best dose of muscadine grape skin extract (MGE) in treating patients with malignancy (tumor or cancer) that has spread to other parts of the body or cannot be removed by surgery. MGE is a nutritional supplement containing an extract of the skin of ...
What is the current status of trial NCT02583269?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-03. Estimated completion is 2023-04-24.
What interventions are being tested in trial NCT02583269?
The interventions under investigation include: Quality-of-Life Assessment (PROCEDURE), Laboratory Biomarker Analysis (DIAGNOSTIC_TEST), Muscadine Grape Skin Extract (DRUG).
Who is sponsoring clinical trial NCT02583269?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02583269's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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