Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00287833
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men
A Phase 1 study testing Bowman-Birk inhibitor concentrate in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Bowman-Birk inhibitor concentrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer
- Male
- Performance status - ECOG 0-2
- RBC normal
- WBC ≥ 3,000/mm^3
- Platelet count normal
Show all 40Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- placebo, Bowman-Birk inhibitor concentrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Also called PLCB
Given orally
Bowman-Birk inhibitor concentrateDrug
Also called BBIC
Given orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)
Measured: Up to 4 weeks
Secondary outcomes (1)
Pharmacokinetics measurements of BBI in the blood and urine
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.
Measured: 0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert Lustig, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287833
- Sponsor's protocol ID
- NCI-2011-01479
- Other IDs
- UPCC-706366, N01-CN-25118, CDR0000429594
- Status last verified
- May 2013
- First submitted
- 6 Feb 2006
- Last updated
- 3 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00287833
- Acronym / sponsor ID
- NCI-2011-01479
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2006
- Primary completion
- Apr 2007 (actual)
- First posted
- 7 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Bowman-Birk inhibitor concentrate) | Experimental | Drug: Bowman-Birk inhibitor concentrateParticipants 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. |
| Arm II (placebo) | Placebo comparator | Other: placeboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Healthy volunteer
- Male
- Performance status - ECOG 0-2
- RBC normal
- WBC ≥ 3,000/mm^3
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboAlso: PLCBGiven orally | Other | Arm II (placebo) |
| Bowman-Birk inhibitor concentrateAlso: BBICGiven orally | Drug | Arm I (Bowman-Birk inhibitor concentrate) |
Primary outcome
Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD)
Time frame: Up to 4 weeks
1 secondary outcome
Pharmacokinetics measurements of BBI in the blood and urine
Time frame: 0 (immediately prior to BBIC administration), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, and 48 hours after BBIC administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Lustig principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bowman-Birk inhibitor concentrate in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by NCI Common Toxicity Criteria and a recommended Phase II dose (RPTD) (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.