Clinical trial · Interventional
A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
NCT00118638CI-TRIAL-00010145completedPhase 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 evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.
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 - 2.25 mcg/kg | Drug | — | UNRESOLVED |
| Darbepoetin alfa - 500mcg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Darbepoetin alfa 500 mcg - Group A
- interventionNames
- Drug: Darbepoetin alfa - 500mcg
- type
- ACTIVE_COMPARATOR
- label
- Darbepoetin alfa 2.25 mcg/kg - Group B
- interventionNames
- Drug: Darbepoetin alfa - 2.25 mcg/kg
Primary outcomes (1)
- measure
- Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP)
- timeFrame
- from week 5 to EOTP
Secondary outcomes (16)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-myeloid malignancy * At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule * Eastern Cooperative Oncology Group performance status of 0-2 * Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization * Of legal age at the time written informed consent is obtained Exclusion Criteria: * Known history of seizure disorder * Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy * Unstable or uncontrolled disease/condition, related to or affecting cardiac function * Clinically significant inflammatory disease * Inadequate renal and/or liver function * Known positive HIV test * Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO * Received more than 2 red blood cell (RBC) transfusions within 4 weeks before 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 before randomization or any planned erythropoietic therapy between randomization and study day 1 * Other investigational procedures * Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority * Pregnant or breast feeding * Not using adequate contraceptive precautions * Known sensitivity to any of the products to be administered during dosing * Previously randomized in this study * Concerns for subject's compliance with protocol procedures
References
Publications (4)
- BACKGROUNDCanon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B,
- RESULTCanon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B, Bridges K. Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus >/= 10 g/dL: an exploratory analysis of a phase 3 trial. Med Oncol. 2012 Sep;29(3):2291-9. doi: 10.1007/s12032-011-0103-x. Epub 2011 Nov 13. PMID 22081263
- RESULTCanon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, Rossi G, Amado RG. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst. 2006 Feb 15;98(4):273-84. doi: 10.1093/jnci/djj053. PMID 16478746
- RESULTVansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Hamilton L, Bridges K, Pujol B. Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus > or = 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial. BMC Cancer. 2009 Sep 3;9:311. doi: 10.1186/1471-2407-9-311. PMID 19728887