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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002049-21 | Other Identifier | EudraCT |
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This study investigates the pharmacokinetics of YM155, identifies the metabolic profile of YM155 and evaluates the safety and tolerability of YM155 after a 3-hour infusion in patients with advanced cancer
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM155 | Drug | I.V. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of YM155 after a 3-hour infusion | Day -1 up to and including Day of discharge (Day 11) |
| Measure | Description | Time Frame |
|---|---|---|
| To identify the metabolic profile of YM155 | Day -1 up to and including Day of discharge (Day 11) | |
| To evaluate the safety and tolerability of YM155 through vital signs, laboratory analysis, adverse events, physical exams, ECOG performance status and echo-cardiography |
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Inclusion Criteria:
Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors or non-Hodgkin's lymphomas for which YM155 has the potential, based on preclinical and/or clinical data, to show efficacy, namely:
Life expectancy ≥ 3 months; and Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale at baseline
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budapest | 1122 | Hungary |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C523798 | sepantronium |
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| Screening (Day -21 to -2), Day -1 up to and including Day of discharge (Day 11) and end of study visit (7-14 weeks after discharge) |