Prostatic NeoplasmsPhase 2NCT00291005
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone
A Phase 2 study testing ARD6562, Docetaxel in people with Prostatic Neoplasms, run by Sanofi at 1 site in Japan.
Trial summary
To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer To evaluate PSA (tumor marker) response rate To evaluate safety Read more about this study
- Who is it for?
- Ages 20 to 74 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- ARD6562, Docetaxel
- How many people
- 42 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2004to not given
- 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 20 to 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.
Who cannot join
- 1.Body temperature > 38 degree centigrade.
- 2.Prior radiotherapy to > 25% of bone marrow.
- 3.Prior isotope therapy and/or brachytherapy
- 4.Prior gene therapy.
- 5.Active double cancer.
- 6.Known brain or leptomeningeal involvement.
Show all 9Show fewer
- 7.History of hypersensitivity reaction to drug
- 8.Other serious illness or medical condition
- 9.Subjects whom the investigators consider inappropriate from social or medical aspects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer
- To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer
- To evaluate PSA (tumor marker) response rate
- To evaluate safety
- Conditions
- Prostatic Neoplasms
- Being tested
- ARD6562, Docetaxel
- Keywords
- Prostate cancer, HRPC, AIPC, Hormone refractory, Androgen independent, Docetaxel, Taxotere, prednisolone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARD6562, DocetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
Secondary outcomes (1)
Overall response rate by modified WHO criteria, PSA response rate, safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Atsushi NAKAMURA, Study chair, CSD, PL / TA-Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291005
- Sponsor's protocol ID
- ARD6562
- Other IDs
- XRP6976J/2101
- Status last verified
- Mar 2009
- First submitted
- 10 Feb 2006
- Last updated
- 27 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00291005
- Acronym / sponsor ID
- ARD6562
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate cancer, HRPC, AIPC, Hormone refractory, Androgen independent, Docetaxel, Taxotere, prednisolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- First posted
- 13 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.
- To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer
- To evaluate PSA (tumor marker) response rate
- To evaluate safety
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.
Key exclusion criteria (9 listed)
- 1.Body temperature > 38 degree centigrade.
- 2.Prior radiotherapy to > 25% of bone marrow.
- 3.Prior isotope therapy and/or brachytherapy
- 4.Prior gene therapy.
- 5.Active double cancer.
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 |
|---|---|---|
| ARD6562, Docetaxel | Drug | – |
Primary outcome
Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST)
1 secondary outcome
Overall response rate by modified WHO criteria, PSA response rate, safety
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 27 Mar 2009.
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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.
Atsushi NAKAMURA study chair
CSD, PL / TA-Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARD6562, Docetaxel in people with Prostatic Neoplasms, run by Sanofi at 1 site 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 9 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 27 Mar 2009. 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 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 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.
What does the primary outcome measure?
Overall tumor response rate by Response Evaluation Criteria in Solid Tumor (RECIST). 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 27 Mar 2009.