Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 6:22 AM
Study NCT ID:
NCT00098969
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2004-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRB 2004-535
Brief Summary:
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of resveratrol may prevent cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in preventing cancer in healthy participants.
PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in preventing cancer in healthy participants.
Detailed Description:
OBJECTIVES:
* Determine the concentration of resveratrol and its metabolites in the plasma, urine, and feces of healthy participants.
* Correlate dose with systemic concentration of this drug and its metabolites in these participants.
* Determine the safety of this drug in these participants.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Beginning 5 days before study drug administration, participants are put on a controlled diet (avoiding all resveratrol-containing food or drink) for washout. Participants receive oral resveratrol once on day 1.
Cohorts of 10 participants receive escalating doses of resveratrol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 10 participants experience dose-limiting toxicity. A total of 16 participants are treated at the MTD.
Participants are followed at 2 and 7 days.
PROJECTED ACCRUAL: A total of 10-40 participants will be accrued for this study within 6 months.
* Determine the concentration of resveratrol and its metabolites in the plasma, urine, and feces of healthy participants.
* Correlate dose with systemic concentration of this drug and its metabolites in these participants.
* Determine the safety of this drug in these participants.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Beginning 5 days before study drug administration, participants are put on a controlled diet (avoiding all resveratrol-containing food or drink) for washout. Participants receive oral resveratrol once on day 1.
Cohorts of 10 participants receive escalating doses of resveratrol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 10 participants experience dose-limiting toxicity. A total of 16 participants are treated at the MTD.
Participants are followed at 2 and 7 days.
PROJECTED ACCRUAL: A total of 10-40 participants will be accrued for this study within 6 months.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA046592 | NIH | None | https://reporter.nih.gov/quic… | View |
| CCUM-2004-0535 | None | None | View | |
| CCUM-2062 | None | None | View |