Treatment for Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy

Amgen

Status and phase: Completed; Phase 2

Conditions: Anemia; Neoplasms

Treatments: Drug: darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00120705

20020167

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)