Anemia, Non-Myeloid Malignancies
Conditions
Brief summary
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).
Interventions
DRUGDarbepoetin alfa SC
Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
DRUGDarbepoetin alfa IV
Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP | 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 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 |
| 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 |
| Percentage of subjects who exceed the hemoglobin threshold | throughout study |
Outcome results
None listed