Prostate CancerPhase 2NCT00257478
A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy
A Phase 2 study testing YM155 in people with Prostate Cancer and Cancer of Prostate, run by Astellas Pharma Inc at 9 sites in 3 countries.
Trial summary
A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously treated with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Cancer of Prostate, Prostatic Cancer
- What is being tested?
- YM155
- How many people
- Not given
- Where
- 9 sitesin 3 countries
- Study dates
- Start not givento Mar 2007
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed prostate cancer.
- Prior chemotherapy regimen for prostate cancer
Who cannot join
- History of other malignancy in the last 5 years
- Major surgery within the past 21 days
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites
Study site
Coeur d'Alene, Idaho, 83814
Study site
Los Angeles, California, 90033
Study site
New York, New York, 10016
Study site
Philadelphia, Pennsylvania, 19111
Study site
San Antonio, Texas, 78229
Study site
The Bronx, New York, 10461
Study site
Tuscon, Arizona, 85724
About this study
A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously treated with chemotherapy.
- Being tested
- YM155
- Keywords
- Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM155Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study completionMar 2007
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Investigators
- D. Buell, MD, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257478
- Sponsor's protocol ID
- 155-CL-007
- Status last verified
- Jun 2012
- First submitted
- 22 Nov 2005
- Last updated
- 7 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT00257478
- Acronym / sponsor ID
- 155-CL-007
- Keywords
- Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study completion
- Mar 2007 (actual)
- First posted
- 23 Nov 2005 (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.
A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously treated with chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed prostate cancer.
- Prior chemotherapy regimen for prostate cancer
Key exclusion criteria (2 listed)
- History of other malignancy in the last 5 years
- Major surgery within the past 21 days
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 |
|---|---|---|
| YM155 | Drug | – |
Primary outcome
Not reported in the source record.
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 7 Jun 2012.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
D. Buell, MD study director
Astellas Pharma US, Inc.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM155 in people with Prostate Cancer and Cancer of Prostate, run by Astellas Pharma Inc at 9 sites in 3 countries.
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 2 inclusion and 2 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Netherlands, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 7 Jun 2012.