| May 3, 2002 |
| September 11, 2008 |
| December 2001 |
| December 2002 (final data collection date for primary outcome measure) |
| Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP) [ Time Frame: from baseline to the end of treatment period (EOTP) ] [ Designated as safety issue: No ] |
| Change in Hgb value from baseline to EOTP |
| Complete list of historical versions of study NCT00035607 on ClinicalTrials.gov Archive Site |
- 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 [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP [ Time Frame: from baseline to week 7 and from week 7 to EOTP ] [ Designated as safety issue: No ]
- Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
- Time to and percentage of subjects with a hemoglobin response during the treatment period [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
- Percentage of subjects who exceed the hemoglobin threshold [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Incidence, if any, of neutralizing antibody formation to darbepoetin alfa [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
|
| Change in Hgb from baseline to week 7 and from week 7 to EOTP |
| |
| Chemotherapy Related Anemia |
| A Randomized, Open-Label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy |
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). |
| |
| Phase II |
| Interventional |
| Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
- Anemia
- Non-Myeloid Malignancies
|
- Drug: Darbepoetin alfa SC
- Drug: Darbepoetin alfa IV
|
| |
| 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. Epub 2005 Apr 28. |
| |
| Completed |
| 120 |
| April 2003 |
| December 2002 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Diagnosed with a non-myeloid malignancy
- Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug
- Screening hemoglobin concentration less than or equal to 11.0g/dL
- ECOG performance status of 0 to 2
- Adequate renal and liver function
Exclusion Criteria:
- History of seizure disorder
- Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1
- More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00035607 |
| Global Development Leader, Amgen Inc. |
| 20010199 |
| Amgen |
|
|
|
| Amgen |
| September 2008 |
