MelanomaPhase 2NCT01009775
A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
A Phase 2 study testing YM155 and Docetaxel in people with Melanoma, run by Astellas Pharma Inc at 13 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel in subjects with Stage III (unresectable) and 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 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Nov 2009to Aug 2012
- 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 Stage III (unresectable) or Stage IV melanoma
- No prior systemic treatment or Cytotoxic chemotherapy for advanced melanoma (Stage III or Stage IV)
- If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
- Eastern Cooperative Oncology Group (ECOG) performance status </= 1
- Life expectancy > 12 weeks
- At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors ({RECIST} version 1.1)
- Subjects with a previous history of non-melanoma malignancy must have undergone curative therapy for all prior malignancies and be considered disease free for at least 5 years
Who cannot join
- Major surgery within 21 days of the Baseline Visit
- Presence or history of brain metastases
- Primary ocular, choroidal or mucosal melanoma
- Known history of positive test for Hepatitis B surface Antigen (HsbAg) or Hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
- Hypersensitivity to docetaxel or polysorbate 80
- Neuropathy greater than or equal to Grade 2 at Baseline Visit
- The subject has been previously treated with YM155
- Inadequate marrow, hepatic, and/or renal functions
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Univ. of Michigan Health System
Ann Arbor, Michigan, 48105
Univ. of Michigan Health System
Ann Arbor, Michigan, 48109/48109
University of Colorado
Aurora, Colorado, 80045
St. Lukes Hospital Cancer Center
Bethlehem, Pennsylvania, 18015
MD Anderson Cancer Center
Houston, Texas, 77030
The Angeles Clinic and Research
Los Angeles, California, 90025
UCLA
Los Angeles, California, 90095
University of South Alabama
Mobile, Alabama, 36604
University of South Alabama
Mobile, Alabama, 36619/36604
Redwood Regional Medical Group
Sebastopol, California, 95472
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Arizona Clinical Research Center
Tuscon, Arizona, 85715
About this study
Official title: A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
The purpose of the study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel in subjects with Stage III (unresectable) and Stage IV melanoma.
Read the detailed description
All subjects will receive YM155 and docetaxel given in a 21-day cycle. The docetaxel dose will be established based on the findings of the lead-in portion of the study (Part 1). Once the docetaxel dose is established, Part 2 enrollment will begin.
Part 1:
Part 1 is a lead-in stage that will confirm if YM155 can be safely administered in combination with docetaxel at a specified dose.
Part 2:
Subjects enrolled in Part 2 will receive YM155 and docetaxel at the dose established during Part 1.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM155Drug
intravenous infusion
DocetaxelDrug
Also called Taxotere
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| YM155 plus docetaxel | Experimental | Not described Receives: Drug: YM155; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Progression-free survival
Measured: After the last non-progressing subject completes 6 months or discontinues the treatment
Secondary outcomes (7)
Objective response rate (proportion of subjects with complete response or partial response)
Measured: After the last non-progressing subject completes 6 months or discontinues the treatment
1 year survival
Measured: After the last non-progressing subject completes 6 months or discontinues the treatment
Overall survival
Measured: 2 years after the last subject discontinues treatment
Duration of response
Measured: After the last non-progressing subject completes 6 months or discontinues the treatment
Clinical benefit rate
Measured: After the last non-progressing subject completes 6 months or discontinues the treatment
Time to response
Measured: After the last non-progressing subject completes 6 months or discontinues the treatment
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionAug 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009775
- Sponsor's protocol ID
- 155-CL-034
- Other IDs
- 2009-015738-31, 2009
- Status last verified
- Aug 2015
- First submitted
- 6 Nov 2009
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label Study Of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT01009775
- Acronym / sponsor ID
- 155-CL-034
- Conditions
- Melanoma
- Keywords
- Melanoma, Stage III, Melanoma, Stage IV, YM 155, Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Nov 2009 (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 the study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel in subjects with Stage III (unresectable) and Stage IV melanoma.
Detailed description
All subjects will receive YM155 and docetaxel given in a 21-day cycle. The docetaxel dose will be established based on the findings of the lead-in portion of the study (Part 1). Once the docetaxel dose is established, Part 2 enrollment will begin.
Part 1:
Part 1 is a lead-in stage that will confirm if YM155 can be safely administered in combination with docetaxel at a specified dose.
Part 2:
Subjects enrolled in Part 2 will receive YM155 and docetaxel at the dose established during Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YM155 plus docetaxel | Experimental | Drug: YM155, Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma
- No prior systemic treatment or Cytotoxic chemotherapy for advanced melanoma (Stage III or Stage IV)
- If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
- Eastern Cooperative Oncology Group (ECOG) performance status </= 1
- Life expectancy > 12 weeks
Key exclusion criteria (8 listed)
- Major surgery within 21 days of the Baseline Visit
- Presence or history of brain metastases
- Primary ocular, choroidal or mucosal melanoma
- Known history of positive test for Hepatitis B surface Antigen (HsbAg) or Hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
- Hypersensitivity to docetaxel or polysorbate 80
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 |
|---|---|---|
| YM155intravenous infusion | Drug | YM155 plus docetaxel |
| DocetaxelAlso: Taxotereintravenous infusion | Drug | YM155 plus docetaxel |
Primary outcome
6-month Progression-free survival
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
7 secondary outcomes
Objective response rate (proportion of subjects with complete response or partial response)
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
1 year survival
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
Overall survival
Time frame: 2 years after the last subject discontinues treatment
Duration of response
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
Clinical benefit rate
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
Time to response
Time frame: After the last non-progressing subject completes 6 months or discontinues the treatment
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Time frame: Monthly
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 4 Sep 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.
Sr. Medical Director study director
Astellas Pharma Global Development
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM155 and Docetaxel in people with Melanoma, run by Astellas Pharma Inc at 13 sites in 2 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 7 inclusion and 8 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 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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?
6-month Progression-free survival (time frame: After the last non-progressing subject completes 6 months or discontinues the treatment). 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 4 Sep 2015.