Status:
COMPLETED
Treatment for Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy
Lead Sponsor:
Amgen
Conditions:
Neoplasms
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W).
Eligibility Criteria
Inclusion
- Subjects with non-myeloid malignancies - Anemia (screening hemoglobin concentration greater than or equal to 10.5 g/dL but less than or equal to 12.0 g/dL) related to cancer and chemotherapy - At least 8 additional weeks of cyclic chemotherapy planned regardless of schedule - Karnofsky Performance Status of greater than or equal to 50% - Serum creatinine concentration less than or equal to 2.0 mg/dL
Exclusion
- Iron deficiency - Red blood cell (RBC) transfusion within 4 weeks of screening - Unstable cardiac disease
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2003
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00120705
Start Date
November 1 2002
End Date
September 1 2003
Last Update
March 25 2009
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