Prostate CancerPhase 1/2NCT00514267
An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
A Phase 1/2 study testing YM 155, Docetaxel and Prednisone in people with Prostate Cancer and Tumors, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
To determine the feasibility and safety of administering YM155 in combination with docetaxel Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Tumors
- What is being tested?
- YM 155, Docetaxel and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Mar 2010
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1:
- Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.
- Part 2:
- Subjects with histologically and cytologically confirmed solid tumors with measurable disease (except HRPC).
Who cannot join
- Radiation therapy within 4 weeks of the start of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Multicenter, Open-Label Study of YM155 Plus Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
To determine the feasibility and safety of administering YM155 in combination with docetaxel
Read the detailed description
This clinical trial is designed to include two parts:
Part 1: Assessment of feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (HRPC) [ ENROLLMENT COMPLETED ]
Part 2: Assessment of feasibility and safety of administering YM155 in combination with docetaxel in subjects with solid tumors (except HRPC).
This registration has been updated to reflect the design requirements of PART 2.
- Conditions
- Prostate Cancer, Tumors
- Being tested
- YM 155, Docetaxel, Prednisone
- Keywords
- Prostate Cancer, HRPC, Hormone Refractory Prostate Cancer, YM155, Treatment Outcome, Solid Tumors
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM 155Drug
IV
DocetaxelDrug
IV
PrednisoneDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1. HRPC | Experimental | Not described Receives: Drug: YM 155; Drug: Docetaxel; Drug: Prednisone |
| 2. Solid Tumors | Experimental | Not described Receives: Drug: YM 155; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)
Measured: 2 cycles
Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)
Measured: 1 cycle
Secondary outcomes (2)
Assessment of safety and efficacy
Measured: 10 cycles
Assessment of pharmacokinetics
Measured: Part 1 only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2010
- Study completionMar 2010
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514267
- Sponsor's protocol ID
- 155-CL-025
- Status last verified
- Jul 2015
- First submitted
- 7 Aug 2007
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Multicenter, Open-Label Study of YM155 Plus Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT00514267
- Acronym / sponsor ID
- 155-CL-025
- Conditions
- Prostate Cancer, Tumors
- Keywords
- Prostate Cancer, HRPC, Hormone Refractory Prostate Cancer, YM155, Treatment Outcome, Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Aug 2007 (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 determine the feasibility and safety of administering YM155 in combination with docetaxel
Detailed description
This clinical trial is designed to include two parts:
Part 1: Assessment of feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (HRPC) [ ENROLLMENT COMPLETED ]
Part 2: Assessment of feasibility and safety of administering YM155 in combination with docetaxel in subjects with solid tumors (except HRPC).
This registration has been updated to reflect the design requirements of PART 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. HRPC | Experimental | Drug: YM 155, Drug: Docetaxel, Drug: Prednisone |
| 2. Solid Tumors | Experimental | Drug: YM 155, Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.
- Subjects with histologically and cytologically confirmed solid tumors with measurable disease (except HRPC).
Key exclusion criteria (1 listed)
- Radiation therapy within 4 weeks of the start of study drug
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 |
|---|---|---|
| YM 155IV | Drug | 1. HRPC, 2. Solid Tumors |
| DocetaxelIV | Drug | 1. HRPC, 2. Solid Tumors |
| PrednisoneOral | Drug | 1. HRPC |
Primary outcome
Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC)
Time frame: 2 cycles
Occurrence of dose limiting toxicities (Part 2: Subjects with other solid tumors)
Time frame: 1 cycle
2 secondary outcomes
Assessment of safety and efficacy
Time frame: 10 cycles
Assessment of pharmacokinetics
Time frame: Part 1 only
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 13 Aug 2015.
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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.
Central Contact study director
Astellas Pharma Global Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YM 155, Docetaxel and Prednisone in people with Prostate Cancer and Tumors, run by Astellas Pharma Inc 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 4 inclusion and 1 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 13 Aug 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Occurrence of dose limiting toxicities (Part 1: Subjects with HRPC) (time frame: 2 cycles). The study lists 2 primary outcomes in all. 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 13 Aug 2015.