(20290) A Phase 1/2 Study of the Oral TRK Inhibitor Larotrectinib in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors - 20290

Bayer Consumer Care AG0 个研究点目标入组 155 人开始时间: 2023年10月13日最近更新: 2024年8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: 155

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

入排标准

年龄范围: 0 至 64（—）
性别: All

入选标准

•Phase 1 (Closed): Phase 1: Birth through 21 years of age at cycle 1 day 1 (C1D1) with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies and 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 neurotrophic tyrosine kinase receptor (NTRK) fusion that has progressed or was nonresponsive to available therapies, and for which no standard or available curative therapy exists. or: Patients with locally advanced infantile fibrosarcoma (IFS) who would require, in the opinion of the Investigator, disfiguring surgery or limb amputation to achieve a complete surgical resection. Phase 1 dose escalation cohorts are closed to enrollment. Phase 1 dose expansion: In addition to the above stated Inclusion Criteria, patients eligible for enrollment into this cohort must have a malignancy with a documented NTRK gene fusion with the exception of patients with IFS, congenital mesoblastic nephroma tumors (CMN) or secretory breast cancer (SBC). Patients with IFS, CMN or SBC may enroll into this cohort with documentation of an ETS variant gene 6 (ETV6) rearrangement by fluorescence in situ hybridization (FISH) or reverse transcription polymerase chain reaction (RT-PCR) or a documented NTRK fusion by next generation sequencing (NGS)., Phase 2: Infants from birth and older at C1D1 with a locally advanced or metastatic IFS, patients with locally advanced IFS who would require, in the opinion of the Investigator, disfiguring surgery or limb amputation to achieve a complete surgical resection withdocumented 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 and for which no standard or available systemic curative therapy exists, with a documented NTRK gene fusion e.g., by NGS, or in the case of IFS, CMN or SBC with documented ETV6 rearrangement (or NTRK3 rearrangement after discussion with the Sponsor) by FISH or RT-PCR. Documented NTRK fusion by NGS shall be 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. or: (including Expansion Phase) Potential patients older than 21 years of age with a tumor diagnosis with histology typical of a pediatric patient and an NTRK fusion may be considered for enrollment following discussion between the local site Investigator and the Sponsor., patients with primary CNS tumors or cerebral metastasis, Karnofsky (those 16 years and older) or Lansky (those younger than 16 years) performance score of at least 50., Adequate hematologic function, Adequate hepatic and renal function

排除标准

•Major surgery within 14 days (2 weeks) prior to C1D1., Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to C1D1, ongoing cardiomyopathy; current prolonged QTc interval > 480 milliseconds., Active uncontrolled systemic bacterial, viral, or fungal infection., Malabsorption syndrome or other condition affecting oral absorption., Current treatment with a strong CYP3A4 inhibitor or inducer. Enzyme-inducing anti-epileptic drugs (EIAEDs) and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed., Pregnancy or lactation., Phase 2 Only: Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK, including entrectinib, repotrectinib, 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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