SYNCHRONICITY: A Study to Evaluate the Effectiveness of Aranesp® at 300 Mcg Q3W on Clinical Outcomes in Cancer Patients With Anemia Due to Chemotherapy
Inclusion Criteria:
- Subjects with non-myeloid malignancy - Anemia (Hgb less than 11.0
g/dL) due to cancer chemotherapy - Receiving chemotherapy and expected to receive at least
8 additional weeks of chemotherapy - Adequate renal function - Adequate liver function
Exclusion Criteria: - Subjects with acute myelogenous leukemia (AML), chronic myelogenous
leukemia (CML), or myelodysplastic syndromes (MDS) - Unstable cardiac disease - Active
bleeding - Active systemic or chronic infection - Severe active chronic inflammatory
disease - Other hematologic disorder associated with anemia - Uncontrolled hypertension -
Known iron or nutritional deficiency - Known positive test for human immunodeficiency
virus (HIV) infection - History of pure red cell aplasia - History of positive antibody
response to any erythropoietic agent - Erythropoietin therapy within 4 weeks before
screening - RBC transfusions within 2 weeks prior to screening