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

Phase 3

Completed

• Conditions: Anemia

• Registration Number: NCT00117624
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study Completion: 2003-12
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-08
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-20
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
RBC transfusion during the treatment phase

Secondary Outcome Measures

Name	Time	Method
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