Clinical trial · Interventional
Chemotherapy Related Anemia
A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
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 | — |
| Non-Myeloid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darbepoetin alfa IV | Drug | — | UNRESOLVED |
| Darbepoetin alfa SC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Darbepoetin alfa SC
- interventionNames
- Drug: Darbepoetin alfa SC
- type
- EXPERIMENTAL
- label
- Darbepoetin alfa IV
- interventionNames
- Drug: Darbepoetin alfa IV
Primary outcomes (1)
- measure
- Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
- timeFrame
- from baseline to the end of treatment period (EOTP)
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTJustice G, Kessler JF, Jadeja J, Campos L, Weick J, Chen CF, Heatherington AC, Amado RG. A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa for the treatment of chemotherapy-induced anemia. Ann Oncol. 2005 Jul;16(7):1192-8. doi: 10.1093/annonc/mdi218. Epub 2005 Apr 28. PMID 15860486