EUCTR2016-003498-16-ES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: 2016年12月9日最近更新:
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: between 1 and 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 or
- •= 1 month old 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
- •Patients with locally advanced infantile fibrosarcom who would require in the opinion of the Investigator disfiguring surgery or limb amputation to achieve a complete surgical resection
- •Phase 2: ages=1 month of age at C1D1 with locally advanced or metastatic infantile fibrosarcom who would require in the opinion of the Investigator disfiguring surgery or limb amputation to achieve a complete surgical resection or
- •Ages =1 month 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 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 and able to tolerate oral medications.
- •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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