A Phase 1/2 Study of the Oral TRK Inhibitor Larotrectinib in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors - SCOUT

Bayer Consumer Care AG0 个研究点目标入组 174 人开始时间: 2021年3月8日最近更新: 2021年6月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Bayer Consumer Care AG
入组人数: 174

研究概览入排标准研究者记录与标识符相似试验

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

•Starting from Protocol Version 11 (10 JUL 2019), newly enrolled patients will only enter Phase 2.
•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 with documented ETV6 rearrangement (or NTRK3 rearrangement after discussion with the Sponsor) by FISH or RT-PCR or a documented NTRK fusion by e.g. NGS. 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 exists, with a documented NTRK gene fusion e.g. by NGS or in case of IFS, CMN or SBC with documented ETV6 rearrangement (or NTRK3 rearangement after discussion with the sponsor) by FISH or RT-PCR. Documented NTRK fusion by NGS shall identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories. If CLIA or similar certification of the laboratory performing the molecular assay is not confirmed at the time of consent patients may be included after discussion with
•the Sponsor. 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 utilize double effective birth control methods for the duration of treatment and for 1 month 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: 161
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 13
•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

发起方

Bayer Consumer Care AG

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