Clinical trial · Interventional
Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
NCT00110955CI-TRIAL-00003030completedPhase 3ClinicalTrials.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 compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
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 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Darbepoetin alfa - Group A
- interventionNames
- Drug: Darbepoetin alfa
- type
- PLACEBO_COMPARATOR
- label
- Placebo- Group B
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)
- timeFrame
- from week 5 to EOTP
Secondary outcomes (13)
- measure
- Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with non-myeloid malignancy * At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule * Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization * Adequate serum folate and vitamin B12 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Of legal age at the time written informed consent is obtained Exclusion Criteria: * Known history of seizure disorder * Known primary hematologic disorder causing anemia other than non-myeloid malignancies * Unstable/uncontrolled cardiac condition * Clinically significant inflammatory disease * Other diagnoses not related to the cancer which can cause anemia * Inadequate renal and liver function * Iron deficiency * Known positive test for HIV infection * Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO * Received more than 2 red blood cell (RBC) transfusions within 4 weeks of randomization; or any RBC transfusion within 14 days before randomization; or any planned RBC transfusion between randomization and study day 1 * Received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1 * Other investigational procedures * Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s) * Pregnant or breast feeding * Not using adequate contraceptive precautions * Previously randomized into this study * Known hypersensitivity to any products to be administered * Concerns for subject's compliance
References
Publications (1)
- RESULTHernandez E, Ganly P, Charu V, Dibenedetto J, Tomita D, Lillie T, Taylor K; ARANESP 20030232 Study Group. Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia. Curr Med Res Opin. 2009 Sep;25(9):2109-20. doi: 10.1185/03007990903084164. PMID 19601709