A Phase 3 interventional study of rHuEPO and Darbepoetin alfa in Cancer and Non-Myeloid Malignancies, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-02-28.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 718 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: rHuEPO
Drug: Darbepoetin alfa
rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.
Time to hematopoietic response during the comparative treatment period
Time frame: 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)
Time frame: during the study
Incidence, if any, of neutralizing antibody formation to study drug
Time frame: throughout study
Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin
Time frame: baseline to first month of treatment
Time to 2 g/dL increase in hemoglobin during the comparative treatment period
Time frame: during the comparative treatment period
Change in FACT-Fatigue scale score over time during the comparative treatment period
Time frame: during the comparative treatment period
Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study
Time frame: throughout study
Slope of change in hemoglobin after the first month of treatment
Time frame: baseline to first month of treatment
Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period
Time frame: during the comparative treatment period
Changes in hemoglobin during the maintenance period
Time frame: during the maintenance period
No study locations are listed for this record.
This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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