Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT00287833
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2006-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-01', 'studyFirstSubmitDate': '2006-02-06', 'studyFirstSubmitQcDate': '2006-02-06', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)', 'timeFrame': 'Up to 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics measurements of BBI in the blood and urine', 'timeFrame': '0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration', 'description': 'Mean, median and 95% confidence interval will then be calculated for each parameter for each dose group. The relationship between dose and the above parameters will be investigated using simple linear regression.'}]}, 'conditionsModule': {'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an orange juice suspension, in healthy male participants.\n\nII. Determine a safe dose range of this drug in these participants. III. Determine a recommended phase II dose of this drug in these participants.\n\nSECONDARY OBJECTIVES:\n\nI. Determine the pharmacokinetics of this drug in these participants.\n\nOUTLINE: This is a randomized, placebo-controlled, double-blind, dose-escalation study.\n\nParticipants 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.\n\nAfter completion of study treatment, participants are followed periodically for 4 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer\n* Male\n* Performance status - ECOG 0-2\n* RBC normal\n* WBC ≥ 3,000/mm\\^3\n* Platelet count normal\n* Hemoglobin normal\n* Hematocrit normal\n* ALT and AST normal\n* Bilirubin normal\n* Creatinine normal\n* No history of heart disease\n* EKG normal\n* No history of pancreatitis or obstruction of pancreatic ducts\n* No history of pancreatic cancer or pancreatic adenoma\n* Amylase normal\n* Lipase normal\n* Cholesterol normal\n* Triglycerides normal\n* Serum glucose ± 10% of normal\n* Within 15% of ideal body weight\n* No history of chronic medical condition\n* No history of excessive alcohol consumption (i.e., \\> 2 alcoholic beverages per day on average)\n* No history of amyloidosis\n* Non-smoker\n\n * Former smokers are eligible provided they have not smoked within the past 3 months\n* No history of medical condition that would influence gastrointestinal uptake of the study drug\n* No history of diabetes mellitus\n* No allergy or prior adverse reaction to soybeans\n* Not a vegetarian\n* No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer\n* No evidence of other life-threatening disease\n* No evidence of psychiatric problems\n* More than 12 months since prior chemotherapy\n* More than 1 month since prior experimental drugs\n* More than 3 days since prior consumption of alcoholic beverages\n* More than 2 weeks since prior and no concurrent regular use (i.e., \\> 3 times/week) of nonsteroidal anti-inflammatory drugs\n* More than 2 weeks since prior multivitamin tablets (or other vitamin supplements) of \\> 2 per day\n* No more than 2 multivitamin tablets (or other vitamin supplements) per day during study participation\n* No more than 1 serving of tofu, soy milk, or other primarily soy-based food per day'}, 'identificationModule': {'nctId': 'NCT00287833', 'briefTitle': 'Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NCI-2011-01479'}, 'secondaryIdInfos': [{'id': 'UPCC-706366'}, {'id': 'N01-CN-25118'}, {'id': 'CDR0000429594'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (Bowman-Birk inhibitor concentrate)', 'description': '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.', 'interventionNames': ['Drug: Bowman-Birk inhibitor concentrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II (placebo)', 'description': '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.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Given orally', 'armGroupLabels': ['Arm II (placebo)']}, {'name': 'Bowman-Birk inhibitor concentrate', 'type': 'DRUG', 'otherNames': ['BBIC'], 'description': 'Given orally', 'armGroupLabels': ['Arm I (Bowman-Birk inhibitor concentrate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of The University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Robert Lustig', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}