CTIS2023-505088-35-00进行中（未招募）1 期
A Phase I/II, Open-Label, Dose-Escalation and Expansion Study of Entrectinib (RXDX -101) in Pediatrics with Locally Advanced or Metastatic Solid or Primary CNS Tumors and/or who have no Satisfactory Treatment Options - CO40778
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Sex and age: male or female aged from birth to age < 18 years, Disease status: Phase 1 portion (closed): Patients must have measurable or evaluable disease Phase 2 portion: ?Cohort B: Patients must have measurable or evaluable disease as defined by RANO ?Cohort C (closed) and D: Patients must have measurable or evaluable disease as defined per RECIST v1.1±Curie Scale ?Cohort D: Patients must have measurable or evaluable disease, ?Cohort E (closed): Patients must have measurable or evaluable disease and be assessed according to tumor type as defined per RECIST v1.1±Curie Scale or RANO, Tumor types included below harboring NTRK1/2/3 or ROS1 gene fusions as determined locally by an appropriately validated assay performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently-accredited diagnostic laboratory, or centrally by a Foundation Medicine Clinical Trial Assay or the alternative, approved central laboratory for that region: Phase 1 portion: ?Cohort A: Relapsed or refractory extracranial solid tumors Phase 2 portion: ?Cohort B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions ?Cohort D: Extracranial solid tumors with NTRK1/2/3 or ROS1 gene fusions, Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse, For patients enrolled via local molecular testing, an archival tumor tissue from diagnosis or, preferably, from relapsed disease is required to be submitted for independent central testing at Foundation Medicine, Inc. laboratory or the alternative, approved central assay laboratory for that region, Performance status: Lansky or Karnofsky score = 60% and minimum life expectancy of at least 4 weeks
排除标准
- •Current participation in another therapeutic clinical trial, Known congenital long QT syndrome, History of recent (3 months) symptomatic congestive heart failure or ejection fraction =50% at screening, Known active infections (bacterial, fungal, or viral), All Phase 2 patients: Prior treatment with approved or investigational tyrosine receptor kinase inhibitor (TRK) or ROS1 inhibitors, Incomplete recovery from acute effects of any surgery prior to treatment
研究者
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