NCT01328938

GCPGC in Chemotherapy-induced Neutropenia

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)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is adaptive design and it consists of stage I and stage II. Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy. Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate into this phase.

Detailed description

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.

Conditions

• Chemotherapy Induced Neutropenia

Interventions

Type	Name	Description
BIOLOGICAL	GCPGC 3.6mg	Stage I:Single blinded
BIOLOGICAL	GCPGC 6mg	Stage I: Single blinded;
BIOLOGICAL	Neulasta (pegfilgrastim) 6mg	Stage II: Active comparator, double blinded
BIOLOGICAL	GCPGC 6mg	Experimental: Stage II

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-11-01
• Completion: 2013-05-01
• First posted: 2011-04-05
• Last updated: 2013-11-06

Locations

15 sites across 1 country: South Korea