MelanomaPhase 2NCT00281541
A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma
A Phase 2 study testing YM155 in people with Melanoma, run by Astellas Pharma Inc at 9 sites in United States.
Trial summary
A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- YM155
- How many people
- 29 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2005to Jun 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma
- Life expectancy >12 weeks
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 1 country.
9 sites in 1 country
United States9 sites
Study site
Atlanta, Georgia, 30322
Study site
Aurora, Colorado, 80045
Study site
Little Rock, Arkansas, 72205
Study site
Montclair, New Jersey, 07042
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Salt Lake City, Utah, 84112
Study site
Tuscon, Arizona, 85724
Study site
Washington D.C., District of Columbia, 20010
Study site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma
A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.
Read the detailed description
A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155
- Conditions
- Melanoma
- Being tested
- YM155
- Keywords
- Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety, Malignant Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM155Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate
Measured: 6 cycles
Secondary outcomes (1)
Duration of response
Measured: 6 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startNov 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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)
- Enrolment
- 29 participants (estimated)
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
- NCT00281541
- Sponsor's protocol ID
- 155-CL-008
- Status last verified
- Jun 2012
- First submitted
- 23 Jan 2006
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- 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 Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma
- ClinicalTrials.gov ID
- NCT00281541
- Acronym / sponsor ID
- 155-CL-008
- Conditions
- Melanoma
- Keywords
- Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Safety, Malignant Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Nov 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 25 Jan 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.
A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.
Detailed description
A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155
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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma
- Life expectancy >12 weeks
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
Tumor response rate
Time frame: 6 cycles
1 secondary outcome
Duration of response
Time frame: 6 cycles
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.
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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.
D. Buell, MD study director
Astellas Pharma US, Inc.
9 sites in 1 country: 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 Melanoma, run by Astellas Pharma Inc at 9 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 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. 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?
Tumor response rate (time frame: 6 cycles). 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 7 Jun 2012.