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

- Non-myeloid malignancy - Currently receiving 3-week cyclic chemotherapy treatment with a minimum of 2 additional cycles of chemotherapy planned at the time of enrollment - Anemia predominately due to cancer or chemotherapy (Hb >= 9.0 and < 11.0 g/dL) at the time of screening - 18 years of age or older at the time of screening - Eastern Cooperative Oncology Group (ECOG) score 0-2 - Adequate liver and kidney function

- Known primary hematologic disorder, which could cause anemia, other than non-myeloid malignancies - History of chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), hairy cell leukemia, Burkitt’s lymphoma, or lymphoblastic lymphoma - Serum folate <= 2.0 ng/mL or vitamin B12 <= 200 pg/mL at screening (anemia related to nutritional deficiencies) - Iron deficiency [transferrin saturation (TSAT) < 15% and serum ferritin < 10 ng/mL] at screening - Other diagnoses not related to cancer or chemotherapy, which cause anemia (ie, hemolysis, bleeding, sickle cell anemia) - Clinically significant inflammatory disease as determined by the investigator (eg, rheumatoid arthritis, Crohn’s disease) - Clinically significant co-morbid medical or psychiatric conditions that may impact subject safety or confound the ability to evaluate study endpoint as determined by the investigator - Unstable or uncontrolled cardiac disease or condition (ie, angina, congestive heart failure, or cardiac arrhythmia) - Diastolic blood pressure > 100 mmHg at screening - Known hypersensitivity of erythropoietic-stimulating proteins (ESPs) or any excipients - Known history of pure red cell aplasia - Known positive antibody response to an ESP - Use of investigational agents not approved or any indication during the previous 30 days prior to enrollment - ESP therapy (i.e., recombinant human erythropoietin [rHuEPO] or darbepoetin alfa) within 21 days prior to screening or between screening and the first dose of study drug - RBC transfusion(s) within 21 days prior to screening - Pregnant or breast-feeding women - Previously enrolled in this study - Known to be HIV, hepatitis B or C positive - Any disorder that would compromise the ability of the subject to give written informed consent and comply with study requirements and procedures