Clinical trial · Interventional
Treatment for Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy
A Randomized, Open-Label, Pilot Study to Evaluate Every Three Week Maintenance Dosing of Darbepoetin Alfa Therapy in Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy
NCT00120705CI-TRIAL-00002156completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W).
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 | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| darbepoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W)
Secondary outcomes (1)
- measure
- Assess safety profile of subjects treated with darbepoetin alfa
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: - Subjects with non-myeloid malignancies - Anemia (screening hemoglobin concentration greater than or equal to 10.5 g/dL but less than or equal to 12.0 g/dL) related to cancer and chemotherapy - At least 8 additional weeks of cyclic chemotherapy planned regardless of schedule - Karnofsky Performance Status of greater than or equal to 50% - Serum creatinine concentration less than or equal to 2.0 mg/dL Exclusion Criteria: - Iron deficiency - Red blood cell (RBC) transfusion within 4 weeks of screening - Unstable cardiac disease
References
Publications (1)
- RESULTCharu V, Saidman B, Ben-Jacob A, Justice GR, Maniam AS, Tomita D, Rossi G, Rearden T, Glaspy J. A randomized, open-label, multicenter trial of immediate versus delayed intervention with darbepoetin alfa for chemotherapy-induced anemia. Oncologist. 2007 Oct;12(10):1253-63. doi: 10.1634/theoncologist.12-10-1253. PMID 17962619