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Phase I Single Dose Safety and Pharmacokinetic Study of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age


Phase 1
18 Years
65 Years
Not Enrolling
Male
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Phase I Single Dose Safety and Pharmacokinetic Study of Bowman Birk Inhibitor Concentrate, Delivered as an Orange Juice Suspension to Healthy Male Volunteers Between 18 and 65 Years of Age


PRIMARY OBJECTIVES:

I. Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an
orange juice suspension, in healthy male participants.

II. Determine a safe dose range of this drug in these participants. III. Determine a
recommended phase II dose of this drug in these participants.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics of this drug in these participants.

OUTLINE: This is a randomized, placebo-controlled, double-blind, dose-escalation study.

Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each
dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating
doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension,
on day 1.

After completion of study treatment, participants are followed periodically for 4 weeks.


Inclusion Criteria:



- Healthy volunteer

- Male

- Performance status - ECOG 0-2

- RBC normal

- WBC ≥ 3,000/mm^3

- Platelet count normal

- Hemoglobin normal

- Hematocrit normal

- ALT and AST normal

- Bilirubin normal

- Creatinine normal

- No history of heart disease

- EKG normal

- No history of pancreatitis or obstruction of pancreatic ducts

- No history of pancreatic cancer or pancreatic adenoma

- Amylase normal

- Lipase normal

- Cholesterol normal

- Triglycerides normal

- Serum glucose ± 10% of normal

- Within 15% of ideal body weight

- No history of chronic medical condition

- No history of excessive alcohol consumption (i.e., > 2 alcoholic beverages per day on
average)

- No history of amyloidosis

- Non-smoker

- Former smokers are eligible provided they have not smoked within the past 3
months

- No history of medical condition that would influence gastrointestinal uptake of the
study drug

- No history of diabetes mellitus

- No allergy or prior adverse reaction to soybeans

- Not a vegetarian

- No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer

- No evidence of other life-threatening disease

- No evidence of psychiatric problems

- More than 12 months since prior chemotherapy

- More than 1 month since prior experimental drugs

- More than 3 days since prior consumption of alcoholic beverages

- More than 2 weeks since prior and no concurrent regular use (i.e., > 3 times/week) of
nonsteroidal anti-inflammatory drugs

- More than 2 weeks since prior multivitamin tablets (or other vitamin supplements) of
> 2 per day

- No more than 2 multivitamin tablets (or other vitamin supplements) per day during
study participation

- No more than 1 serving of tofu, soy milk, or other primarily soy-based food per day

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)

Outcome Time Frame:

Up to 4 weeks

Safety Issue:

Yes

Principal Investigator

Robert Lustig

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-01479

NCT ID:

NCT00287833

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283