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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
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)
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
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
Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period
Time frame: during the treatment period
Time to and percentage of subjects with a hemoglobin response during the treatment period
Time frame: during the treatment period
Percentage of subjects who exceed the hemoglobin threshold
Time frame: throughout study
Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events
Time frame: throughout study
Incidence, if any, of neutralizing antibody formation to darbepoetin alfa
Time frame: throughout study
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