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Study Complete
Sponsor ID
20030206

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

Sponsor ID
20030206
Clinicaltrials.gov ID
NCT00117039
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 4
Product
darbepoetin alfa
Type
Interventional
Masking
None (Open Label)
Enrollment
1500
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Anemia
  • Solid Tumor
    • Sex
    All
    Trial Dates
    Feb 2004 - N/A
    Inclusion and Exclusion Criteria
    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