NCT00287833

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

February 6, 2006

Last Update Submit

May 1, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

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

    Up to 4 weeks

Secondary Outcomes (1)

  • Pharmacokinetics measurements of BBI in the blood and urine

    0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration

Study Arms (2)

Arm I (Bowman-Birk inhibitor concentrate)

EXPERIMENTAL

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.

Drug: Bowman-Birk inhibitor concentrate

Arm II (placebo)

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

placeboOTHER

Given orally

Also known as: PLCB
Arm II (placebo)
Bowman-Birk inhibitor concentrateDRUG

Given orally

Also known as: BBIC
Arm I (Bowman-Birk inhibitor concentrate)

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Robert Lustig

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2007

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

US(1)