Treatment for Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy

NCT00120705 ↗

Phase 2 Completed 204 enrolled Amgen

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W).

Timeline

Start: 2002-11
Primary completion: —
Completion: 2003-09

Outcome

Met primary endpoint

paper (primary endpoint): 29% for immediate-intervention patients versus 65% for observation patients. PMID 17962619 ↗

paper there was a significant difference between the two groups in the Kaplan-Meier proportion of patients with a hemoglobin decrease to <10 g/dl during weeks 1-13 PMID 17962619 ↗

Publications

Results Charu V, Saidman B, Ben-Jacob A, Justice GR, Maniam AS, Tomita D, Rossi G, Rearden T, Glaspy J. A randomized, open-label, multicenter trial of immediate versus delayed intervention with darbepoetin alfa for chemotherapy-induced anemia. Oncologist. 2007 Oct;12(10):1253-63. doi: 10.1634/theoncologist.12-10-1253.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darbepoetin alfa	Protein / enzyme biologic	300 ug	—