A Randomized,Multi-center,Parallel-group, Phase II(Single-blind)/Phase III(Double- Blind)Study to Determine the Optimal Dose and to Evaluate the Efficacy and Safety of GCPGC on Chemotherapy-induced Neutropenia Compared to Neulasta(Pegfilgrastim)
GCPGC ia a solution for containing pegfilgrastim. Pegfilgrastim is a covalent conjugate of
recombinant human granulocyte colony-stimulating factor (G-CSF) with a polyethylene glycol
(PEG) which has long half life compared to filgrastim, resulting in dosing advantage.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1
Stage I: The difference in mean duration of grade 4 neutropenia between GCPGC 3.6mg and GCPGC 6mg is measured by check ANC in cycle I. Stage II : The difference in mean duration of grade 4 neutropenia between GCPGC which dose was determined at Stage I and Neulasta is measured by check ANC in cycle 1.
in cycle 1
Do-Youn Oh, M.D., Ph.D.
Seoul National University Hospital
Korea: Food and Drug Administration