drugset / Trial / NCT00111137

Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

NCT00111137

Phase 3 Completed 718 enrolled Amgen
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2003-02
Primary completion
2003-11
Completion
2004-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Darbepoetin alfa Protein / enzyme biologic 4.5 ug/kg
Comparator epoetin alfa Protein / enzyme biologic 40000 iu
Comparator epoetin alfa Protein / enzyme biologic 60000 iu

Indications