A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study

Summary

The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.

Timeline

Start

2004-08

Primary completion

2007-01

Completion

2007-03

Outcome

Missed primary endpoint

paper DA was not associated with a statistically significant reduction in transfusions. PMID 18227526 ↗

Publications

• Smith RE Jr, Aapro MS, Ludwig H, Pinter T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008 Mar 1;26(7):1040-50. doi: 10.1200/JCO.2007.14.2885. Epub 2008 Jan 28.

Drugs

Indications