EUCTR2017-004246-20-FR进行中（未招募）1 期
A Phase 1/2 Study of the TRK Inhibitor LOXO-195 in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers
oxo Oncology, Inc0 个研究点目标入组 103 人开始时间: 2018年1月23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
- 103
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.Advanced solid tumor for which, in the opinion of the Investigator, no other standard therapy offers greater benefit.
- •2.A solid tumor diagnosis in the setting of:
- •a.a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor
- •b.a documented NTRK fusion unresponsive to a prior TRK inhibitor
- •c.a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
- •3.NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified in a CLIA certified (or equivalent) laboratory.
- •4.Performance Status: Eastern Cooperative Oncology Group (ECOG) score 3 (age 16) or Lansky Performance Score (LPS) 40% (age 16). If enrolled with primary CNS tumor to be assessed by RANO, Karnofsky Performance Score (KPS) (age 16) or LPS (age 16) 50%.
- •5.Evaluable and/or measurable disease by RECIST v1.1 or RANO.
- •6.Life expectancy 4 weeks.
- •7.At least 1 month of age.
- •8.Tissue submission. Samples from 2 timepoints are required if available
- •9.Adequate hematologic function, for patients without known bone marrow involvement, defined as:
- •a.Hemoglobin (Hb) = 8.0 g/dL
- •b.Absolute neutrophil count (ANC) = 1.0 × 109 /L
- •c.Platelets (Plt) = 100 × 109 /L without need for regular transfusion support
- •Patients with known bone marrow involvement will not be evaluable for hematologic DLT and can enroll with:
- •a.Hb = 8.0 g/dL (transfusions allowed)
- •b.ANC = 0.75 × 109 /L
- •c.Plt = 50 × 109 /L (transfusions allowed)
- •10.Adequate hepatic function defined as:
- •a.AST and ALT =2.5 × upper limit of normal (ULN) or =5 × ULN if in the setting of liver metastases
- •b.Total bilirubin =1.5 × ULN or =3 × ULN if in the setting of liver metastases or Gilbert's disease; patients with higher total bilirubin levels due to Gilbert's disease or hepatic metastases may be enrolled with Sponsor approval
- •11.For patients age 18 and older: Adequate renal function defined as serum creatinine =2.0 or estimated glomerular filtration = 30 mL/min using Crockroft-Gault formula.
- •For patients up to age 18: Estimated glomerular filtration rate = 30 mL/minute/1.73 m2 based on local institutional practice for determination OR a serum creatinine based on age/gender
- •12.At least 5 half-lives since most recent kinase inhibitor dose OR at least 7 days since last systemic anticancer therapy (whichever is shorter) and recovered to baseline from all toxicity of last cytotoxic chemotherapy dose. Alopecia and other non-acute toxicities are acceptable.
- •13.Patients with stable CNS primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms have been stable for 7 days prior to the first dose of LOXO-195 and there has been no change in steroid dose, if taking steroids to manage CNS symptoms, for 7 days prior to the first dose of LOXO-195. The patient can be receiving any dose of steroids is as long as dosing meets specifications noted above.
- •14.Negative serum pregnancy test prior to C1D1 study drug if a woman of child-bearing age. Pregnancy test are not required for pre-pubertal (Tanner 1) girls. A post-menopausal woman will be defined as having no menses for 12 months without an alternative medical cause.
- •15.Agreement to adequate contraception in male and female patients with reproductive potential for the duration of treatment and for 6 months following study completion.
- •a.Willingness to use double effective birth control methods, defined as one used by the patient and another by his/her partner.
- •b.Oral contraception should always
排除标准
- •1.If received recent therapy, evidence of unstable organ dysfunction due to treatment.
- •2.Concurrent treatment with a strong CYP3A4 inhibitor or inducer.
- •3.Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of LOXO-195, cardiomyopathy; current or known history within the past 6 months of prolonged QTc interval >480 milliseconds. If there is a known explanation for a limited period of a prolonged QT interval (i.e., a medication known to cause prolonged QT interval was administered and has since been discontinued with clearly documented normal QT interval thereafter), that subject may be enrolled.
- •4.Major surgery within 7 days of enrollment. Catheter placement, endoscopic procedures, and dental surgery are not considered major surgery.
- •5.Uncontrolled systemic bacterial, fungal or viral infection. Infections treated with a stable dose of antimicrobial therapy for at least 7 days are allowed.
- •6.Pregnancy or lactation
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