Chemotherapy Related Anemia

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• Diagnosed with a non-myeloid malignancy

• Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug

• Screening hemoglobin concentration less than or equal to 11.0g/dL

• ECOG performance status of 0 to 2

• Adequate renal and liver function

Exclusion Criteria:

• History of seizure disorder

• Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1

• More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1