Chemotherapy Related Anemia

Amgen

Status and phase: Completed; Phase 2

Conditions: Anemia; Non-Myeloid Malignancies

Treatments: Drug: Darbepoetin alfa IV; Drug: Darbepoetin alfa SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035607

20010199

Details and patient eligibility

About

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).

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Darbepoetin alfa SC

Active Comparator group

Treatment:

Drug: Darbepoetin alfa SC

Darbepoetin alfa IV

Experimental group

Treatment:

Drug: Darbepoetin alfa IV