Clinical trial · Interventional
Darbepoetin Alfa and Anemia of Cancer
A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin Alfa on Hospital Days, Economic Outcomes, and Health-related Quality of Life in Subjects With Nonmyeloid Malignancies and Anemia of Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow enrollment and change in product development strategy
Summary
Brief summary (as posted)
This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Anemia of Cancer | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Non-Myeloid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| darbepoetin alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Observational Group
- description
- Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered to the observation group during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
- interventionNames
- Biological: darbepoetin alfa
- type
- ACTIVE_COMPARATOR
- label
- 21 week treatment group
- description
- Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * nonmyeloid malignancies (including lymphocytic leukemias) * anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy * Eastern Cooperative Oncology Group performance status of 0 to 2 * adequate liver and renal functions * 18 years or older Exclusion Criteria: * history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening * acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome * known hematologic disorders that could cause anemia * inflammatory or cardiac disorders * previous positive antibody response to any erythropoietic agent * history of pure red cell aplasia
References
Publications (1)
- RESULTCharu V, Belani CP, Gill AN, Bhatt M, Tomita D, Rossi G, Ben-Jacob A. Efficacy and safety of every-2-week darbepoetin alfa in patients with anemia of cancer: a controlled, randomized, open-label phase II trial. Oncologist. 2007 Jun;12(6):727-37. doi: 10.1634/theoncologist.12-6-727. PMID 17602062