Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies

Phase 2 Completed 44 enrolled Amgen

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of darbepoetin alfa administered at a subcutaneous (SC) dose of 0.45 mcg/kg three times weekly (TIW) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.

Timeline

Start: 2005-08
Primary completion: 2007-01
Completion: 2007-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darbepoetin alfa	Protein / enzyme biologic	0.45 ug/kg	Subcutaneous

Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies

Summary

Timeline

Drugs

Indications