EUCTR2016-003498-16-FR进行中（未招募）1 期
A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors - SCOUT
oxo Oncology Inc.0 个研究点目标入组 84 人开始时间: 2017年12月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
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
- •1.Phase 1: Birth through 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies for whIch no standard or available systemic curative therapy exists or
- •Infants from birth and older with a diagnosis of malignancy and with a documented NTRK fusion that has progressed or was nonresponsive to available therapies for which no standard or systemic curative therapy exists or
- •Phase 2: Patients with locally advanced or metastatic infantile fibrosarcoma who would require in the opinion of the Investigator disfiguring surgery or limb amputation to achieve a complete surgical resection or
- •Birth through 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies for which no standard or available systemic curative therapy with a documented NTRK gene fusion. Patients with NTRK fusion positive benign tumors are also eligible.
- •Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy
- •Willingness of male and female patients with reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following study completion
- •Ability to swallow capsules, liquid or gastric access via a naso- or gastric tube
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 84
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following criteria are to be excluded from study participation:
- •1. Major surgery within 14 days (2 weeks) prior to C1D1.
- •2. Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to C1D1; ongoing cardiomyopathy; or current prolonged QTc interval > 480 milliseconds.
- •3. Active uncontrolled systemic bacterial, viral, or fungal infection.
- •4. Malabsorption syndrome or other condition affecting oral absorption.
- •5. Current treatment with a strong CYP3A4 inhibitor or inducer other than those allowed per Section 6.3.2 of the study protocol.
- •6. Pregnancy or lactation.
- •7. Phase 2 only: Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK, including entrectinib, crizotinib and lestaurtanib. Patients who received a TRK inhibitor for less than 28 days of treatment and discontinued because of intolerance remain eligible.
研究者
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