Treatment for Patients with Non-Myeloid Malignancies Receiving Chemotherapy
Study Details
The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.
Protocol Summary
Time to hematopoietic response during the comparative treatment period
Timeframe: during the comparative treatment period
Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)
Timeframe: during the study
Incidence, if any, of neutralizing antibody formation to study drug
Timeframe: throughout study
Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin
Timeframe: baseline to first month of treatment
Time to 2 g/dL increase in hemoglobin during the comparative treatment period
Timeframe: during the comparative treatment period
Change in FACT-Fatigue scale score over time during the comparative treatment period
Timeframe: during the comparative treatment period
Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study
Timeframe: throughout study
Slope of change in hemoglobin after the first month of treatment
Timeframe: baseline to first month of treatment
Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period
Timeframe: during the comparative treatment period
Changes in hemoglobin during the maintenance period
Timeframe: during the maintenance period