EUCTR2015-000087-34-RO进行中（未招募）1 期
An Open-Label, Randomized, Active-Controlled, Multicenter Study toEvaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety,Tolerability, and Immunogenicity of Lipegfilgrastim 100 µg/kg BodyWeight in Comparison to Filgrastim 5 µg/kg Body Weight in PediatricPatients Diagnosed with Ewing Family of Tumors or RhabdomyosarcomaReceiving Chemotherapy
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
- Merckle GmbH
- 入组人数
- 42
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) Male or female children and adolescents aged 2 to <18 years at screening.
- •b) Written informed consent provided by parent(s)/legal representative(s) of the
- •pediatric patient and patient’s assent if appropriate, before screening procedures
- •are initiated.
- •c) Able to understand and/or follow study instructions alone or with parental
- •assistance.
- •d) Diagnosed with the Ewing family of tumors, or rhabdomyosarcoma.
- •e) Scheduled to receive 1 of the following CTX regimens (inpatient or outpatient):
- •For the Ewing Family of Tumors:
- •? VIDE; with concomitant sodium 2-mercaptoethane sulfonate (MESNA)
- •according to local standards.
- •? VDC/IE; with concomitant MESNA treatment according to local standards.
- •For Rhabdomyosarcoma:
- •? VAC; with concomitant MESNA treatment according to local standards
- •? VDC/IE; with concomitant MESNA treatment according to local standards.
- •? IVA; with concomitant MESNA treatment according to local standards.
- •f) Minimum BW 12.5 kg.
- •g) Life expectancy of at least 3 months with appropriate therapy
- •h) WBC count >2.5 × 109/L, ANC =1.5 × 109/L, and platelet count =100 × 109/L (at
- •screening and prior to CTX)
- •i) For patients aged =12 years, Eastern Cooperative Oncology Group (ECOG) performance status =2 (see Appendix A).
- •j) Fertile patients (male or female) must use highly reliable contraceptive measures (ie, 2 of the following: oral contraception, implants, injections, barrier contraception, and intrauterine device, or vasectomized/sterilized partners, or sexual abstinence) for the entire duration of the study. For purposes of this study, a fertile female patient is any female patient who has experienced menarche and who has not undergone tubal ligation.
- •k) Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 42
- •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. Previous exposure to filgrastim, pegfilgrastim, lenograstim or other granulocyte colony stimulating factors (G-CSFs) / granulocyte macrophage colony-stimulating factors (GM-CSFs) in clinical development within 6 weeks prior to the first lipegfilgrastim/filgrastim
- •administration in this study.
- •b. Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim, any other G-CSF in clinical development or any LONQUEX (lipegfilgrastim) excipients.
- •c. History of congenital neutropenia or cyclic neutropenia.
- •d. Patients with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests, or imaging.
- •e. Pregnancy or breast feeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
- •f. Prior bone marrow or stem cell transplant, or prior radiation to =25% of bone marrow (eg, whole pelvic radiation) for any reason, or any therapeutic radiation within the 3 weeks prior to the first dose of study drug (lipegfilgrastim/filgrastim).
- •g. Major surgery or serious infection within 3weeks before first administration of study drug (lipegfilgrastim/filgrastim), serious trauma or compound medical procedure within the 4 weeks prior to the first study drug dose.
- •h. Treatment with lithium at screening or planned during the study.
- •i. Participation in a clinical study within 30 days before randomization.
研究者
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