Darbepoetin Alfa With or Without Intravenous (IV) Iron

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy.

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

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa; Dextrans; Iron; Iron-Dextran Complex

Criteria

Inclusion Criteria:

• Active non myeloid malignancy(cies) including lymphocytic leukemias

• Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy

• Anemia due to chemotherapy (screening Hgb- at least 18 years of age at screening

Exclusion Criteria:

• Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS)

• Other underlying hematologic disorder, which could cause anemia, other than a non myeloid malignancy

• Active bleeding

• Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic ulcer disease, rheumatoid arthritis)

• Active, unstable systemic or chronic infection

• Planned elective surgery during the study where significant blood loss is expected

• Unstable angina, or uncontrolled cardiac arrhythmia

• Uncontrolled hypertension (diastolic blood pressure > 100 mmHg)

• History of pure red cell aplasia (PRCA)

• History of deep venous thrombosis

• Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status

• Any red-blood-cell (RBC) transfusion within 28 days before randomization and/or during screening

• Currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy

• Currently receiving or planned to receive myeloablative radiation therapy

• Received bone marrow or stem cell transplant in the 6 months prior to screening or planned during the study

• Received any erythropoietic therapy within 28 days before randomization and/or during screening (eg rHuEPO or darbepoetin alfa)

• Known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study

• Known sensitivity to iron administration

• Pregnant or breast feeding