A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy
- Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with
non-myeloid malignancies receiving chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and
type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12
weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).
- Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are
followed at 1 and 3 weeks .
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this
study within 6 months.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.
John A. Glaspy, MD, MPH
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|