Status:
COMPLETED
Darbepoetin Alfa With or Without Intravenous (IV) Iron
Lead Sponsor:
Amgen
Conditions:
Anemia
Non-Myeloid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 treat...
Eligibility Criteria
Inclusion
- 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 \<or = 10.0 g/dL)
- at least 18 years of age at screening
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT00401544
Start Date
December 1 2006
End Date
March 1 2008
Last Update
January 29 2014
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