An Open Label, Randomized, Active Controlled, Dose Finding Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim at Doses of 300 µg/kg and 670 µg/kg in Pediatric Patients Diagnosed With Solid Tumors Receiving Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Area under the curve (AUC) of absolute neutrophil count (ANC)
研究概览
简要总结
The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving 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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytologically-confirmed solid tumor in a patient for whom the study chemotherapy regimen [Vincristine plus ifosfamide plus doxorubicin plus etoposide (VIDE), Vincristine plus doxorubicin plus cyclophosphamide alternating with ifosfamide plus etoposide (VDC/IE), Ifosfamide plus vincristine plus actinomycin D (IVA) or Ifosfamide plus vincristine plus Adriamycin (IVAd)] is considered an appropriate treatment.
- •Minimum body weight of 15 kg
- •Life expectancy of at least 3 months with appropriate therapy
- •Female or male children and adolescents aged 2 to 17 years
- •Written informed consent provided by parent(s)/legal representative(s) of the pediatric patient and patient's assent if appropriate at the time of screening.
- •Fertile patients (male or female) must use highly reliable contraceptive measures.
- •Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
- •White blood cell (WBC) count >2.5*10^9/L, ANC ≥1.5*10^9/L, and platelet count ≥100*10^9/L (at screening and prior to chemotherapy)
排除标准
- •Primary myeloid disorders
- •Prior radiation therapy within 4 weeks of randomization into this study.
- •Previous exposure to filgrastim, pegfilgrastim, lenograstim or other G-CSF less than 6 months before randomization.
- •Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim or any balugrastim excipients
- •Pregnancy or breastfeeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
- •Major surgery, serious infection, within 3 weeks before first administration of study drug, serious trauma or compound medical procedure within the 4 weeks prior to the first study drug dose.
- •Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, laboratory tests or imaging.
研究组 & 干预措施
Balugrastim 300 ug/kg
Balugrastim 300 μg/kg subcutaneously (SC) administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles
干预措施: Balugrastim (Drug)
Balugrastim 670 μg/kg
Balugrastim 670 μg/kg (maximum 40 mg) SC administration once per chemotherapy cycle, approximately 24 h after chemotherapy, up to 4 cycles
干预措施: Balugrastim (Drug)
Filgrastim 5 μg/kg
Filgrastim will be administered at a dose of 5 μg/kg SC once a day for at least 5 consecutive days or until absolute neutrophil count (ANC) has returned to ≥2*10^9/L for each chemotherapy cycle up to 4 cycles. The maximum period of filgrastim administration is 14 days in each cycle.
干预措施: Filgrastim (Drug)
结局指标
主要结局
Area under the curve (AUC) of absolute neutrophil count (ANC)
时间窗: Day 1 to 14
次要结局
- Frequency of febrile neutropenia(Baseline to Week 16)
- Summary of Participants with Adverse Events(From signing of informed consent to 16 weeks)
- ANC nadir(Baseline to Week 16)
- Duration of severe neutropenia (DSN)(Baseline to Week 16)
- Time to ANC nadir(Baseline to Week 16)
- Incidence of severe neutropenia(Baseline to Week 16)
- Time to ANC recovery(Baseline to Week 16)