Randomized, Open, Multi-Center, Phase III Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy
Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or
daily G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each
cycle is repeated every 21 days.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Duration of grade 4 neutropenia in cycle 1
Grade 4 neutropenia means the ANC count is less than 500/mm3.
JaeHong Seo, M.D.
Korea University Guro Hospital
South Korea: Korea Food and Drug Administration (KFDA)