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 3 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方: Bayer Consumer Care AG
入组人数: 3

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（—）

入选标准

•Inclusion Criteria
•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 and for which no standard or available
•systemic curative therapy exists,
•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, and for which no standard or available curative therapy exists.
•Patients with locally advanced infantile fibrosarcoma who would require, in the
•opinion of the Investigator, disfiguring surgery or limb amputation to achieve
•a complete surgical resection
•The 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 onto this cohort must have a malignancy with a
•documented NTRK gene fusion.,
•Phase 2: Infants from birth and older at C1D1 with a locally advanced or
•metastatic infantile fibrosarcoma, Patients with locally advanced 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.
•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 with a documented NTRK gene fusion with the exception
•of patients with IFS (Infantile FibroSarcoma), CMN (Congenital Mesoblastic
•Nephroma tumors) or SBC (Secretory Breast Cancer), they may enroll into this
•cohort with documentation of an ETV6 rearrangement by FISH or RT-PCR.
•Documented NTRK fusion by NGS (Next Generation Sequencing) 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.
•(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.,
•2. Patients with primary CNS tumors or cerebral metastasis:
•a) Must be neurologically stable based on stable neurologic exam for 7 days
•prior to enrollment.
•b) Must have not required increasing doses of steroids within the 7 days prior
•to study entry to manage CNS symptoms
•c) Phase 2 only: Imaging study must be performed within 28 days of C1D1 while
•on stable dose steroid medication (if needed) for at least 7 days immediately
•before the imaging study., 3. Histologic verification of malignancy at original
•diagnosis or relapse, except in patients with intrinsic brain stem tumors,
•optic pathway gliomas, or patients with pineal tumors and elevations of

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 QT
•interval corrected for heart rate (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 cytochrome P450 3A4 (CYP3A4) inhibitor or inducer other than
•those allowed per Section 6.3.2., 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 tropomyosin-related kinase (TRK) inhibitor for less
•than 28 days of treatment and discontinued because of intolerance remain

研究者

发起方

Bayer Consumer Care AG

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