Prostate CancerPhase 1NCT00644488
A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer
A Phase 1 study testing BMS-641988 (AR#2) in people with Prostate Cancer, run by Bristol-Myers Squibb at 3 sites in Japan.
Trial summary
The purpose of this clinical study is to assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- BMS-641988 (AR#2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesJapan
- Study dates
- Jul 2008to Mar 2009
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with castration-resistant prostate cancer and serum testosterone ≤50 ng/dL progressive to current therapy who satisfy the inclusion and exclusion criteria
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Local Institution
Hamamatsu, Shizuoka, 431-3192
Local Institution
Hidaka, Saitama, 3501298
Local Institution
Koto-Ku, Tokyo, 1358550
About this study
The purpose of this clinical study is to assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
- Conditions
- Prostate Cancer
- Being tested
- BMS-641988 (AR#2)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-641988 (AR#2)Drug
Tablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Active Receives: Drug: BMS-641988 (AR#2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
Measured: throughout the study
Secondary outcomes (4)
To evaluate the pharmacokinetics of BMS-641988 and the metabolites BMS-501949 and BMS-570511
Measured: at cycle 1 day 1, day 15 and day 29
To identify the dose(s) of BMS-641988 for Phase II
Measured: at the end of study
To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans
Measured: throughout the study
To assess the effects of BMS-641988 on pharmacodynamic markers (LH, total and free testosterone, 5(alpha)-DHT, estradiol, prolactin, FSH, and SHBG)
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
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 Bristol-Myers SquibbThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644488
- Sponsor's protocol ID
- CA185-005
- Status last verified
- May 2009
- First submitted
- 20 Mar 2008
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT00644488
- Acronym / sponsor ID
- CA185-005
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Mar 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 this clinical study is to assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: BMS-641988 (AR#2)Active |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with castration-resistant prostate cancer and serum testosterone ≤50 ng/dL progressive to current therapy who satisfy the inclusion and exclusion criteria
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 |
|---|---|---|
| BMS-641988 (AR#2)Tablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks | Drug | A1 |
Primary outcome
To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
Time frame: throughout the study
4 secondary outcomes
To evaluate the pharmacokinetics of BMS-641988 and the metabolites BMS-501949 and BMS-570511
Time frame: at cycle 1 day 1, day 15 and day 29
To identify the dose(s) of BMS-641988 for Phase II
Time frame: at the end of study
To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans
Time frame: throughout the study
To assess the effects of BMS-641988 on pharmacodynamic markers (LH, total and free testosterone, 5(alpha)-DHT, estradiol, prolactin, FSH, and SHBG)
Time frame: throughout the study
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 25 Jan 2011.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 BMS-641988 (AR#2) in people with Prostate Cancer, run by Bristol-Myers Squibb at 3 sites in Japan.
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 1 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 25 Jan 2011. 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 Japan. 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?
To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer (time frame: throughout the study). 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 25 Jan 2011.