Flexibility: A Study to Assess the Impact of Darbepoetin Alfa in Subjects withNon-Myeloid Malignancies With Anemia Due to Chemotherapy

Summary

This study will compare the efficacy (non-inferiority) of darbepoetin alfa (Aranesp®) extended dose schedule administration (EDS) versus darbepoetin alfa administered once per week (QW) in the treatment of anemia in subjects with non-myeloid malignancies receiving multi-cycle chemotherapy.

Timeline

Start

2005-08

Primary completion

—

Completion

—

Outcome

Met primary endpoint

paper The upper limit of the 95% confidence interval was less than the prespecified limit of <0.75 g/dL, supporting noninferiority of the EDS dosing schedule. PMID 20973982 ↗

Publications

• Results Schwartzberg L, Burkes R, Mirtsching B, Rearden T, Silberstein P, Yee L, Inamoto A, Lillie T. Comparison of darbepoetin alfa dosed weekly (QW) vs. extended dosing schedule (EDS) in the treatment of anemia in patients receiving multicycle chemotherapy in a randomized, phase 2, open-label trial. BMC Cancer. 2010 Oct 25;10:581. doi: 10.1186/1471-2407-10-581.

Drugs

Indications