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

Inclusion Criteria: 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 Exclusion Criteria: 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