Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer.


Study summary:

OBJECTIVES: I. Assess the toxicity of single-dose Bowman-Birk Inhibitor Concentrate (BBIC) when administered as a suspension in orange juice in healthy male participants. II. Determine the appropriate dose range and doses to be used in a subsequent phase I multiple-dose BBIC study that will be based upon the data gathered from this phase I single-dose study. III. Characterize the pharmacokinetics of single-dose BBIC. OUTLINE: This is a dose-escalation study of Bowman-Birk Inhibitor Concentrate (BBIC). Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo or BBIC. Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension, immediately followed by consumption of a defined low-fat breakfast. Participants continue to consume a low-fat diet for the next 48 hours and then resume their normal diet. Participants undergo blood and urine sample collection periodically for pharmacokinetic studies. Samples are analyzed by a sandwich enzyme-linked immunosorbent assay to measure concentrations of BBIC and its metabolites in serum and urine. After completion of study treatment, participants are followed once weekly for 4 weeks.


Criteria:

Inclusion Criteria: - Healthy male participant recruited from the Philadelphia, Pennsylvania metropolitan area - ECOG performance status 0-2 - WBC ≥ 3,000/uL - Differential (i.e., neutrophils, lymphocytes, monocytes, bands, eosinophils, and basophils) normal - Platelet count normal - Hemoglobin normal - Hematocrit normal - RBC normal - Creatinine normal - Bilirubin normal - ALT and AST normal - Amylase and lipase normal - Glucose normal - Cholesterol normal - Triglycerides normal - Non-smoker - Former smokers are eligible provided they have not smoked within the past 3 months - Within 15% of ideal body weight based on standard weight tables - No vegetarians or individuals who normally ingest large amounts of soy products, defined as two or more servings of tofu, soy milk, or other primarily soy-based food per day - No prior allergy or adverse reaction to soybeans - No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer - No prior diagnosis of pancreatitis, pancreatic carcinoma, pancreatic adenoma, diabetes mellitus, obstruction of pancreatic ducts, or amyloidosis - No history of heart disease - EKG normal (normal variants allowed) - No evidence of psychiatric problems - No history of excessive alcohol consumption (i.e., an average of > 2 alcoholic beverages per day) - No alcohol consumption within the past 3 days - No history of any medical condition that could influence gastrointestinal uptake of the drug - No history of chronic medical condition - No evidence of another life-threatening disease - More than 12 months since prior chemotherapy - More than 1 month since prior experimental drugs - More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of nonsteroidal anti-inflammatory drugs (NSAIDs) - More than 2 weeks since prior and no concurrent multivitamin tablets (or other vitamin supplements) of > 2 per day


NCT ID:

NCT00679094


Primary Contact:

Principal Investigator
Lilie Lin
Abramson Cancer Center of the University of Pennsylvania


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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