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
Sponsor study identifier
Secondary identifiers
interventional
20
1 country
1
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2007
Actual (reported)Study Completion
Not reported
Date not reportedThis 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
February 6, 2006
Actual (reported)February 7, 2006
Actual (reported)April 2007
Actual (reported)Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)
Up to 4 weeks
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
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.
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.
Given orally
Given orally
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Robert Lustig
Abramson Cancer Center at Penn Medicine
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2007
Actual (reported)AFP464 in Treating Patients With Advanced Solid Tumors
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Last Updated
May 3, 2013
Record last verified: 2013-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: