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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 15
- 主要终点
- Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •women(≥ 18 years old) diagnosed with breast cancer who are receiving chemotherapy inducing neutropenia
- •body weight of 45kg and more
- •ECOG performance status 2 and less
- •ANC ≥1,500mm3 and Platelet ≥100,000/mm3
- •life expectancy of 3 months and more
- •given written informed consent
排除标准
- •had previous exposure to pegfilgrastim or filgrastim
- •had received systemic antibiotics within 72hrs of chemotherapy
- •prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m or epirubicin more than 600 mg/m
研究组 & 干预措施
Stage I - Arm I: GCPGC I (3.6mg)
GCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
干预措施: GCPGC 3.6mg (Biological)
Stage I - Arm II: GCPGC II (6mg)
GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
干预措施: GCPGC 6mg (Biological)
Stage II - Arm I: GCPGC
GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1).
The recommended dose in Stage II was determinated as GCPGC 6mg in Stage I.
干预措施: GCPGC 6mg (Biological)
Stage II - Arm II: Neulasta
Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)
干预措施: Neulasta (pegfilgrastim) 6mg (Biological)
结局指标
主要结局
Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1
时间窗: 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.
次要结局
- ANC values at Day 7 in all cycles (only for Stage II)(Day 7 in alll cycles)
- Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II)(in clycle 2-6)
- Number of intravenous antimicrobial treatments due to febrile neutropenia(in all cycles)
- Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II)(all cycles)
- Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1(in cycle 1)
- Depth of ANC nadir in cycle 1(in cycle 1)
- Rates of Febrile neutropenia in all cycles(in all cycles)
- Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II)(in cycle 1)