CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Muscadine Grape Skin Extract +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02583269
NCT02583269Phase 1Completed
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Phase I Study of Muscadine Grape Extract (MGE) in Advanced Malignancy

Wake Forest University Health Sciences·interventional·Posted Oct 22, 2015·Updated Jun 5, 2023

In Brief

A Phase 1 clinical trial evaluating Laboratory Biomarker Analysis, Muscadine Grape Skin Extract, and 1 other intervention for Advanced Malignant Neoplasm and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Unresectable Malignant Neoplasm
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 22, 2015
Enrollment StartMar 1, 2016
Primary CompletionDec 19, 2017
Study CompletionApr 24, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.7 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Muscadine Grape Skin Extractdrug

Given PO

Quality-of-Life Assessmentprocedure

Ancillary studies