Phase 2
Completed N=238
Darbepoetin Alfa With or Without Intravenous (IV) Iron
Anemia · Non-Myeloid Malignancies
Source: ClinicalTrials.gov NCT00401544 ↗
Enrolled (actual)
238
Serious AEs
36.1%
Results posted
Jan 2014
Primary outcomePrimary: Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose — 71; 82 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose |
71; 82 | — |
| PRIMARY Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage |
73; 80 | — |
| SECONDARY Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose |
10.0; 8.0 | — |
| SECONDARY Time to Achieve the Target Hemoglobin Level, by IV Iron Usage |
9.0; 8.0 | — |
| SECONDARY Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose |
1.5; 1.6 | — |
| SECONDARY Change From Baseline in Hemoglobin Concentration, by IV Iron Usage |
1.3; 1.9 | — |
| SECONDARY Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose |
45; 43 | — |
| SECONDARY Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage |
47; 41 | — |
| SECONDARY Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study |
14; 17; 18; 15 | — |
| SECONDARY Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose |
70; 81 | — |
| SECONDARY Number of Participants With a Hematopoietic Response, by IV Iron Usage |
65; 86 | — |
| SECONDARY Time to Hematopoietic Response, by Darbepoetin Alfa Dose |
11.0; 9.0 | — |
| SECONDARY Time to Hematopoietic Response, by IV Iron Usage |
12.0; 8.0 | — |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose |
3.1; 0.6 | — |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage |
1.0; 2.7 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00401544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.