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Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424


Phase 1
18 Years
80 Years
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Healthy participants

PATIENT CHARACTERISTICS:

Age

- 18 to 80

Performance status

- WHO 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 1,500/mm^3

- Platelet count 120,000-450,000mm^3

- Hemoglobin 10.5-17.5 g/dL for women OR 11.5-19.0 g/dL for men

Hepatic

- Bilirubin 0.05-1.2 mg/dL

- AST and ALT < 1.5 times normal

Renal

- Creatinine normal

- Urinalysis normal

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile participants must use effective contraception

- Willing to abstain from ingesting large quantities of resveratrol-containing foods

- Willing to spend 24 hours in the hospital

- No cancer diagnosis that is currently under treatment, is clinically detectable, or
that has been treated within the past 5 years except basal cell or squamous cell skin
cancer

- No concurrent excessive alcohol intake (>21 units per week for men; 14 units per week
for women)

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Concurrent hormone replace ment therapy allowed

- Concurrent oral or depot contraceptives allowed

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- At least 2 weeks since prior and no concurrent vitamin supplements of any type

- More than 6 months since prior and no concurrent participation in any other
experimental study

- No other concurrent chronic medications, including over-the-counter medications,
herbal/natural preparations, or dietary supplements

- No other concurrent prescribed medication

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Prevention

Principal Investigator

Dean E. Brenner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000396464

NCT ID:

NCT00098969

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752