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

Last updated: December 20, 2007
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Neoplasms

Anemia

Treatment

N/A

Clinical Study ID

NCT00117624
20020118
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Non-myeloid malignancy - At least 12 additional weeks of cycliccytotoxic chemotherapy anticipated regardless of schedule - ECOG 0-2 - Cancer and/or

Exclusion

chemotherapy-associated anemia Exclusion Criteria: - Known history of seizure disorder -Known primary hematologic disorder, which could cause anemia, other than a non-myeloidmalignancy - Unstable or uncontrolled disease/condition, related to or affecting cardiacfunction - Clinically significant inflammatory disease - Inadequate renal and/or liverfunction

Study Design

Study Start date:
December 01, 2002
Estimated Completion Date:
December 31, 2003