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

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