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Study for the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.

A Study of Darbepoetin Alfa Administered Once Every 2 Weeks (Q2W) Compared With Epoetin Alfa Administered Once Every Week (QW) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00148421
Enrollment
Unknown
Registered
2005-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2013-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Non-myeloid malignancy, Chemotherapy-induced anemia

Brief summary

Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Detailed description

The purpose of this study is to compare the effect of darbepoetin alfa and Epoetin alfa for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Interventions

DRUGDarbepoetin alfa and Epoetin alfa

Sponsors

Amgen
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Subjects must provide written informed consent

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 - Known positive test for HIV infection - Neutralizing antibodies to rHuEPO - Epoetin alfa or darbepoetin alfa therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to recombinant mammalian-derived product - Concerns for subject's compliance

Design outcomes

Primary

MeasureTime frame
Reduced incidence of transfusions—

Secondary

MeasureTime frame
Change in hemoglobin concentration—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026