NCT01923545已完成2 期
Multi-Center, Randomized, Open, Phase II 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Duration of grade 4 neutropenia in cycle 1
研究概览
简要总结
This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared to daily G-CSF in chemotherapy-induced neutropenia.
详细描述
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 1 cycles of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage II or III breast cancer
- •Age : ≥18, ≤70
- •TAC regimen as adjuvant therapy
- •ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1
- •Creatinine < 1.5 x ULN
- •Total bilirubin/AST/ALT < 1.5 x ULN, ALP < 2.5 x ULN
- •Have given a written, informed consent
排除标准
- •Received any other investigational drugs within 30 days of informed consent date
- •Received systemic antibiotics within 72 hours of chemotherapy into this study or Radiation therapy within 4 weeks of informed consent date
- •Infective symptom before chemotherapy into this study
- •Pregnant or lactating women
- •Prior bone marrow or stem cell transplantation
- •Other malignancy history within 5 years
- •HIV positive
- •Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors within 6 weeks of informed consent date
- •Prior chemotherapy
研究组 & 干预措施
DA-3031 3.6mg
Experimental
PEG-G-CSF
干预措施: PEG-G-CSF (Drug)
DA-3031 6mg
Experimental
PEG-G-CSF
干预措施: PEG-G-CSF (Drug)
Leucostim®
Active Comparator
G-CSF
干预措施: G-CSF (Drug)
结局指标
主要结局
Duration of grade 4 neutropenia in cycle 1
时间窗: 21 day
Grade 4 neutropenia means the ANC count is less than 500/mm3.
次要结局
- ANC nadir in cycle 1(21 day)
- Time to ANC recovery in cycle 1(21 day)
- Incidence of febrile neutropenia in cycle 1(21 day)
- Incidence of IV antibiotics administration in cycle 1(21 day)
研究者
研究点 (1)
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