A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy

A Randomized, Double-Blind, Study of Front-Loading Darbepoetin Alfa Compared With Standard Weekly Administration for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy and Receiving Multicycle Chemotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00117624

Enrollment

Unknown

Registered

2005-07-08

Start date

2002-12-31

Completion date

2003-12-31

Last updated

2007-12-28

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, Darbepoetin alfa, Clinical Trial

Brief summary

The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a front-loading approach with subjects receiving standard weekly dosing in the treatment of anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.

Interventions

DRUGdarbepoetin alfa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Non-myeloid malignancy - At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule - ECOG 0-2 - Cancer and/or chemotherapy-associated anemia

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

Design outcomes

Primary

Measure	Time frame
RBC transfusion during the treatment phase	—

Secondary

Measure	Time frame
The time to hemoglobin response during the treatment phase	—
The FACT-Fatigue score profile over time	—
The change in hemoglobin	—
Incidence and severity of adverse events	—

Outcome results

None listed

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