Clinical Trial: GCPGC in Chemotherapy-induced Neutropenia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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 Summary: 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.
Sponsor: Green Cross Corporation
Current Primary Outcome: Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1 [ Time Frame: in 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.
Original Primary Outcome: Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1 [ Time Frame: day1-21 in cycle 1 ]
Stage I ; The difference in mean duration of grade 4 neutropenia between GCPGC 3.6mg and GCPGC 6mg is measured by daily check(Day1-Day9) of 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 Filgrastim is measured by daily check of ANC(Day1-9) in cycle 1.
Current Secondary Outcome:
- Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1 [ Time Frame: in cycle 1 ]
- Depth of ANC nadir in cycle 1 [ Time Frame: in cycle 1 ]
- Rates of Febrile neutropenia in all cycles [ Time Frame: in all cycles ]Stage I: only in cycle 1; Stage II: in all cycles
- Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II) [ Time Frame: in cycle 1 ]
- ANC values at Day 7 in all cycles (only for Stage II) [ Time Frame: Day 7 in alll cycles ]
- Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II) [ Time Frame: all cycles ]
- Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II) [ Time Frame: in clycle 2-6 ]
- Number of intravenous antimicrobial treatments due to febrile neutropenia [ Time Frame: in all cycles ]
Original Secondary Outcome:
- Rates of Febrile neutropenia in all cycles [ Time Frame: day 1-21 in all cycles ]
- Duration of severe neutropenia(ANC<500mm3),cycle 2-4 [ Time Frame: day 1-21, cycle 2-4 ]
Information By: Green Cross Corporation
Dates:
Date Received: February 6, 2011
Date Started: October 2010
Date Completion:
Last Updated: November 5, 2013
Last Verified: November 2013