A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• Non-myeloid malignancy

• At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule

• Eastern Cooperative Oncology Group performance status of 0-2

• Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization

• Of legal age at the time written informed consent is obtained

Exclusion Criteria:

• Known history of seizure disorder

• Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy

• Unstable or uncontrolled disease/condition, related to or affecting cardiac function

• Clinically significant inflammatory disease

• Inadequate renal and/or liver function

• Known positive HIV test

• Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO

• Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC transfusion between randomization and study day 1

• Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1

• Other investigational procedures

• Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority

• Pregnant or breast feeding

• Not using adequate contraceptive precautions

• Known sensitivity to any of the products to be administered during dosing

• Previously randomized in this study

• Concerns for subject's compliance with protocol procedures