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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015738-31 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YM155 plus docetaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM155 | Drug | intravenous infusion |
| |
| Docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Progression-free survival | After the last non-progressing subject completes 6 months or discontinues the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (proportion of subjects with complete response or partial response) | After the last non-progressing subject completes 6 months or discontinues the treatment | |
| 1 year survival | After the last non-progressing subject completes 6 months or discontinues the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36604 | United States | ||
| University of South Alabama |
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| Drug |
intravenous infusion |
|
|
| Overall survival | 2 years after the last subject discontinues treatment |
| Duration of response | After the last non-progressing subject completes 6 months or discontinues the treatment |
| Clinical benefit rate | After the last non-progressing subject completes 6 months or discontinues the treatment |
| Time to response | 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) | Monthly |
| Mobile |
| Alabama |
| 36619/36604 |
| United States |
| Arizona Clinical Research Center | Tuscon | Arizona | 85715 | United States |
| The Angeles Clinic and Research | Los Angeles | California | 90025 | United States |
| UCLA | Los Angeles | California | 90095 | United States |
| Redwood Regional Medical Group | Sebastopol | California | 95472 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Univ. of Michigan Health System | Ann Arbor | Michigan | 48105 | United States |
| Univ. of Michigan Health System | Ann Arbor | Michigan | 48109/48109 | United States |
| St. Lukes Hospital Cancer Center | Bethlehem | Pennsylvania | 18015 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C523798 | sepantronium |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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