A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia

Amgen1,500 enrolled

Overview

The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network (NCCN) guidelines).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,500

Conditions

Anemia Neoplasms

Interventions

Aranesp®DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hemoglobin maintenance

Secondary Outcomes

Quality of Life

Changes in measures of work productivity and anemia treatment convenience

Data from ClinicalTrials.gov

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