EUCTR2019-001155-39-ES进行中（未招募）1 期
A PHASE 1/2, OPEN-LABEL, DOSE-ESCALATION AND EXPANSION STUDY OF ENTRECTINIB (RXDX-101) IN PEDIATRICS AND YOUNG ADULTS WITH NO CURATIVE FIRST-LINE TREATMENT OPTION OR RECURRENT/REFRACTORY SOLID TUMORS AND PRIMARY CNS TUMORS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
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
- •- Body surface area (BSA): Patients must have a BSA >= 0.43 m2 at the time of the study enrollment
- •Disease status:
- •- Phase 1 portion: Patients must have measurable or evaluable disease
- •- Phase 2 portion:
- •– Part B, Part D, Part C: Patients must have measurable or evaluable disease
- •– Part E: Patients must have measurable or evaluable disease and will be assessed according to tumor type
- •- 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-certified or equivalently-accredited diagnostic laboratory, or centrally by a Foundation Medicine Clinical Trial Assay:
- •oPhase 1 portion:
- •– Part A: Relapsed or refractory extracranial solid tumors
- •oPhase 2 portion:
- •– Part B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions
- •– Part 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
- •- Age: Male or female from birth to age < 22 years
- •- Performance status: Lansky or Karnofsky score >= 60% and minimum life expectancy of at least 4 weeks
- •- Prior therapy: The patient’s cancer must have no curative first-line treatment option or recurrent/refractory solid tumors and primary CNS tumors. Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment
- •- Adequate bone marrow, liver, renal, cardiac and neurologic function
- •- Females of childbearing potential must have a negative serum pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation and in the following 90 days after discontinuation of study treatment
- •- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Current participation in another therapeutic clinical trial
- •- Known congenital long QT syndrome
- •- Known active infections (bacterial, fungal, or viral)
- •- Receiving Enzyme Inducing Antiepileptic Drugs within prior 14 days
- •- All Phase 2 patients: Prior treatment with approved or investigational tyrosine receptor kinase inhibitor (TRK) or ROS1 inhibitors
- •- Patients with NB with bone marrow space-only disease
- •- Incomplete recovery from acute effects of any surgery prior to treatment
- •- Active gastrointestinal disease or other malabsorption syndromes that would impact drug absorption
- •- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or entrectinib administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry in to this study or could compromise protocol objectives in the opinion of the Investigator and/or Sponsor
研究者
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