Treatment for Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy

Phase 2

Completed

• Conditions: Neoplasms; Anemia

• Registration Number: NCT00120705
• Lead Sponsor: Amgen

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2003-09
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-18
• Study First Posted: 2005-07-19
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• 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 Criteria

• Iron deficiency - Red blood cell (RBC) transfusion within 4 weeks of screening - Unstable cardiac disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Assess safety profile of subjects treated with darbepoetin alfa