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This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darbepoetin alfa SC | Active Comparator |
| |
| Darbepoetin alfa IV | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darbepoetin alfa SC | Drug | Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP) | from baseline to the end of treatment period (EOTP) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration | throughout study | |
| Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15860486 | Result | Justice G, Kessler JF, Jadeja J, Campos L, Weick J, Chen CF, Heatherington AC, Amado RG. A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa for the treatment of chemotherapy-induced anemia. Ann Oncol. 2005 Jul;16(7):1192-8. doi: 10.1093/annonc/mdi218. Epub 2005 Apr 28. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Darbepoetin alfa IV | Drug | Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W |
|
| from baseline to week 7 and from week 7 to EOTP |
| Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period | during the treatment period |
| Time to and percentage of subjects with a hemoglobin response during the treatment period | during the treatment period |
| Percentage of subjects who exceed the hemoglobin threshold | throughout study |
| Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events | throughout study |
| Incidence, if any, of neutralizing antibody formation to darbepoetin alfa | throughout study |
| FDA-approved Drug Labeling | View source |