Prostate CancerPhase 1STX64PCNCT00790374
BN83495 in Prostate Cancer
A Phase 1 study testing BN83495 (Cohort 1), BN83495 (Cohort 2) and BN83495 (Cohort 3) in people with Prostate Cancer, run by Ipsen at 3 sites in United States.
Trial summary
The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- BN83495 (Cohort 1), BN83495 (Cohort 2) and BN83495 (Cohort 3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2009to Feb 2011
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed and locally advanced or metastatic prostate cancer with rising prostate-specific antigen (PSA), while on androgen ablative therapy.
- Over age 18.
- Demonstrated PSA "biochemical failure".
- Adequate bone marrow and hepatic function
Who cannot join
- Luteinizing Hormone-Releasing Hormone analogue treatment and treated with more than one additional second line of endocrine therapy
- Prior treatment with ketoconazole
- Prior chemotherapy for hormone refractory prostate cancer
- Pre-existing cardiac failure and/or clinically significant abnormal ECG or Echo
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University Medical Center
Baltimore, Maryland, 21231
Duke University Medical Center United States
Durham, North Carolina, 27705
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705
About this study
Official title: A Phase I Dose Escalating Study Evaluating the Pharmacodynamic Profile and Safety of BN83495 in Patients With Prostate Cancer With Evidence of Disease Progression While on Androgen Ablative Therapy
The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy
Read the detailed description
Evaluate the PD profile of BN83495 after 28 days of daily oral administration in patients with locally advanced or metastatic prostate cancer on androgen ablative therapy and with rising prostatic specific antigen
- Conditions
- Prostate Cancer
- Being tested
- BN83495 (Cohort 1), BN83495 (Cohort 2), BN83495 (Cohort 3)
- Keywords
- Pharmacodynamic profile and safety of BN83495
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BN83495 (Cohort 1)Drug
20 mg daily BN83495 for 28 days
BN83495 (Cohort 2)Drug
40 mg daily BN83495 for 28 days
BN83495 (Cohort 3)Drug
60 mg daily BN83495 for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 6 patients have been enrolled, the cohort has been completed. Receives: Drug: BN83495 (Cohort 1) |
| Cohort 2 | Experimental | 6 patients have been enrolled in cohort 2, the cohort has been completed. Receives: Drug: BN83495 (Cohort 2) |
| Cohort 3 | Experimental | 5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled. Receives: Drug: BN83495 (Cohort 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints
Measured: 28 days
Secondary outcomes (2)
Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)
Measured: Each visit through day 28/29
Pharmacokinetic assessments/Pharmacodynamic assessments
Measured: Pre-determined timepoints from baseline to day 28/29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790374
- Sponsor's protocol ID
- X-52-58064-003
- Acronym
- STX64PC
- Status last verified
- Jan 2019
- First submitted
- 11 Nov 2008
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalating Study Evaluating the Pharmacodynamic Profile and Safety of BN83495 in Patients With Prostate Cancer With Evidence of Disease Progression While on Androgen Ablative Therapy
- ClinicalTrials.gov ID
- NCT00790374
- Acronym / sponsor ID
- STX64PC / X-52-58064-003
- Conditions
- Prostate Cancer
- Keywords
- Pharmacodynamic profile and safety of BN83495
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 13 Nov 2008 (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.
The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy
Detailed description
Evaluate the PD profile of BN83495 after 28 days of daily oral administration in patients with locally advanced or metastatic prostate cancer on androgen ablative therapy and with rising prostatic specific antigen
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BN83495 (Cohort 1)6 patients have been enrolled, the cohort has been completed. |
| Cohort 2 | Experimental | Drug: BN83495 (Cohort 2)6 patients have been enrolled in cohort 2, the cohort has been completed. |
| Cohort 3 | Experimental | Drug: BN83495 (Cohort 3)5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed and locally advanced or metastatic prostate cancer with rising prostate-specific antigen (PSA), while on androgen ablative therapy.
- Over age 18.
- Demonstrated PSA "biochemical failure".
- Adequate bone marrow and hepatic function
Key exclusion criteria (4 listed)
- Luteinizing Hormone-Releasing Hormone analogue treatment and treated with more than one additional second line of endocrine therapy
- Prior treatment with ketoconazole
- Prior chemotherapy for hormone refractory prostate cancer
- Pre-existing cardiac failure and/or clinically significant abnormal ECG or Echo
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 |
|---|---|---|
| BN83495 (Cohort 1)20 mg daily BN83495 for 28 days | Drug | Cohort 1 |
| BN83495 (Cohort 2)40 mg daily BN83495 for 28 days | Drug | Cohort 2 |
| BN83495 (Cohort 3)60 mg daily BN83495 for 28 days | Drug | Cohort 3 |
Primary outcome
Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints
Time frame: 28 days
2 secondary outcomes
Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)
Time frame: Each visit through day 28/29
Pharmacokinetic assessments/Pharmacodynamic assessments
Time frame: Pre-determined timepoints from baseline to day 28/29
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 15 Jan 2019.
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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.
Ipsen Medical Director study director
Ipsen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BN83495 (Cohort 1), BN83495 (Cohort 2) and BN83495 (Cohort 3) in people with Prostate Cancer, run by Ipsen at 3 sites 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 4 inclusion and 4 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints (time frame: 28 days). 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 15 Jan 2019; AzTrials last refreshed its copy on 3 Nov 2026.