Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098969
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2004-12-08
Brief Title:
UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCUM-2062 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA046592 |
| P30CA046592 | NIH | None | None |
| CCUM-2004-0535 | None | None | None |