A Randomized, Open-Label, Dose-Timing Study Of Darbepoetin Alfa Administered Once Every 3 Weeks (Q3W) by Subcutaneous (SC) Injection For Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
- Compare the efficacy of darbepotein alfa administered on the same day as chemotherapy
vs an alternate time to chemotherapy administration for the treatment of anemia in
patients with nonmyeloid malignancies receiving multiple courses of chemotherapy.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to screening hemoglobin (less than 10.0 g/dL vs 10.0-11.0 g/dL) and participating
center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive darbepoetin alfa subcutaneously (SC) on day 15 of each
- Arm II: Patients receive darbepoetin alfa SC on day 1 of each chemotherapy course.
In both arms, treatment repeats every 3 weeks for up to 5 courses in the absence of
unacceptable toxicity or treatment failure.
PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study within
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
John A. Glaspy, MD, MPH
Jonsson Comprehensive Cancer Center
United States: Federal Government