EUCTR2012-005432-28-CZ进行中（未招募）1 期
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.
Teva Pharmaceuticals Industries Ltd.0 个研究点目标入组 36 人开始时间: 2013年8月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a. Histologically- 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.
- •b. Minimum body weight (BW) of 15 kg
- •c. Life expectancy of at least 3 months with appropriate therapy
- •d. Female or male children and adolescents aged 2 to 17 years
- •e. 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.
- •f. Fertile patients (male or female) must use highly reliable contraceptive measures (ie, two of the following: oral contraception, implants, injections, barrier contraception, and intrauterine device, or vasectomized/sterilized partners, or sexual abstinence). For the purposes of this study, a fertile female patient is any female patient who has experienced menarche and who has not undergone tubal ligation.
- •g. Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
- •h. White blood cell (WBC) count >2.5 x 10(9)/L, absolute neutrophil count (ANC) =1.5 x 10(9)/L, and platelet count =100 x 10(9)/L (at screening and prior to chemotherapy)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Primary myeloid disorders
- •b. Previous chemotherapy or wide-field irradiation to the pelvis
- •c. Previous exposure to filgrastim, pegfilgrastim, lenograstim or other granulocyte-colony stimulating factor (G-CSF) less than 6 months before randomization.
- •d. Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim or any balugrastim excipients
- •e. Pregnancy or breastfeeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
- •f. Major surgery, serious infection, serious trauma or compound medical procedure within the 4 weeks prior to the first study drug dose.
- •g. 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, electrocardiogram (ECG), laboratory tests or imaging.
研究者
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