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This study will evaluate the safety of subcutaneous (SC) epoetin beta (NeoRecormon) in adults with solid tumors being treated with platinum-based chemotherapy capable of inducing anemia. The anticipated time on study treatment is 16 weeks, and the target sample size is approximately 208 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epoetin beta | Experimental | Participants will receive weekly SC injection of epoetin beta (450 international units per kilogram [IU/kg]) for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin beta | Drug | Participants will receive weekly SC injections of epoetin beta beginning at 450 IU/kg, with doses adjusted according to hemoglobin level. Treatment will continue for a total of 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin response rate index | Up to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcoy | 03804 | Spain | ||||
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
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|
| Barakaldo |
| 48903 |
| Spain |
| Barcelona | 08036 | Spain |
| Barcelona | 08041 | Spain |
| Barcelona | 08916 | Spain |
| Cáceres | 10003 | Spain |
| El Palmar Murcia | 30120 | Spain |
| Manresa | 08243 | Spain |
| Salamanca | 37007 | Spain |
| San Cristóbal de La Laguna | 38320 | Spain |
| Valencia | 46010 | Spain |
| Valencia | 46026 | Spain |
| Zaragoza | 50009 | Spain |