Chemotherapy Related Anemia

A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy

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).

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