EUCTR2017-002762-44-IE进行中（未招募）1 期
A phase I/II study evaluating the safety and activity of Pegylated recombinant human Arginase (BCT-100) in Relapsed/refractory cancers of Children and young adults - PARC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
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
- •Aged 2- <25 years old
- •Histologically confirmed disease in one of the following four cohorts. Patients with and without metastatic lesions are eligible.
- •oCohort 1 - Acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML)
- •oCohort 2 - Neuroblastoma
- •oCohort 3 - Sarcoma
- •oCohort 4 - High grade glioma (as defined by 2016 WHO CNS classification)
- •Radiological or laboratory evidence of disease progression (during or after completion of first line treatment) or any subsequent recurrence
- •Measurable bone marrow disease (cohort 1) or at least one evaluable radiological site of disease (cohort 2, 3 and 4)
- •Adequate liver function defined as a total bilirubin <1.5x the upper limit of normal for age and ALT <3x the upper limit of normal for age
- •Normal ECG
- •Documented negative pregnancy test for female patients of childbearing potential within 7 days of trial entry
- •Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 12 months following treatment discontinuation
- •Written informed consent given by patient and/or parents/legal representative
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Previous treatment with another therapeutic arginine depleting drug (bacterial or human) or arginase inhibitor
- •Presence of any = CTCAE grade 3 clinically significant treatment-related toxicity from prior therapies
- •Pregnant or lactating female
- •Evidence of uncontrolled infection
- •History of an anaphylactic (i.e. life-threatening) reaction to kanamycin.
研究者
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