EUCTR2017-004246-20-GB进行中（未招募）1 期
Bayer 20810 - A Phase 1/2 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 186
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.Ability to understand and willingness to sign a written informed consent form (ICF). Signed ICF must be obtained prior to any study-specific procedures. Parent/guardian of child or adolescent subjects has the ability to understand, agree to, and sign the study ICF and applicable paediatric Assent form before initiation of any protocol related procedures; subject has the ability to give assent, as applicable, at the time of parental/guardian consent.
- •2.Advanced solid tumor for which, in the opinion of the Investigator, no other standard therapy offers greater benefit.
- •3.A solid tumor diagnosis in the setting of:
- •a.documented NTRK fusion and clinical history of relapse following a response to a prior TRK inhibitor
- •b.documented NTRK fusion unresponsive to prior TRK inhibitor
- •c.documented NTRK fusion and clinical history of intolerance to prior TRK inhibitor NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified in a CLIA certified (or equivalently-accredited diagnostic) laboratory. If such a report cannot be provided, other available certifications/accreditations are required and need to be documented.
- •4.ECOG score = 2 in adults or KPS Score = 50% (age =16 years ) or LPS = 50% (age < 16yers)
- •5.Evaluable and/or measurable disease by RECIST v1.1, RANO or INRC.
- •6.Life expectancy of at least 3 months.
- •7.At least 1 mth of age.
- •8.Tissue submission. Samples from 2 time points required if available
- •9.Adequate hematologic function, for patients without known or suspected 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 or suspected 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. Patients must have adequate blood clotting, as assessed by the following laboratory requirements to be conducted within 14 days before the first dose of study drug:
- •- International normalized ration (INR) =1.5 X ULN
- •- Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) =1.5 X ULN
- •-Patients on chronic anticoagulation therapy, including direct-acting oral anticoagulants, will be allowed to participate if there is no sign of active bleeding and PT/INR and aPTT or PTT test results are, at the investigator’s discretion, compatible with acceptable benefit-risk ratio
- •12.For patients age 18 yrs and older: Adequate renal function defined as serum creatinine =2.0 mg/dL or estimated glomerular filtration =30 mL/min using CKD-EPI equation. For patients between 1-18 years old: Estimated glomerular filtration rate=30mL/minute/1.73 m2
- •based on the modified Schwartz formula.For patients <1 year old, the serum creatinine should be less than 97.5th percentile (approximately 2 standard deviations).
- •13.At least 5 half-lives since most recent larotrectinib or entrectinib dose. At least 5 halflives OR at least 7 days (whichever is longer) since last dose o
排除标准
- •1.Prior exposure to second generation TRK inhibitor (e.g. selitrectinib, repotrectinib (TPX0005), taletrectinib (DS-6501b/AB-106)). Exception is in case patient presented intolerance to the second generation TRK inhibitor agent and the duration of exposure was less than 28 days. No previous treatment with selitrectinib is allowed.
- •2. If received recent therapy, evidence of moderate-severe/uncontrolled toxicities that in the opinion of the investigator are limiting of subsequent therapy or unstable organ dysfunction due to previous treatment.
- •3. Concurrent treatment with a strong CYP3A4 inhibitor or inducer, consumption of grapefruit juice or Seville orange, or drugs associated with QT prolongation. The Investigator should review concomitant medications with their site pharmacist as the list can change frequently.
- •4. Clinically significant active cardiovascular disease or history of myocardial infarction within 3 months prior to planned start of Selitrectinib, 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. If subject suffers from congestive heart failure, with onset more than 3 months prior to planned start of selitrectinib, then NYHA should be functional capacity I at maximum.
- •5. Major surgery within 7 days of enrollment. Catheter placement, endoscopic procedures, and dental surgery are not considred major surgery.
- •6. Uncontrolled systemic bacterial, fungal or viral infection. Infections treated with a stable dose of antimicrobial therapy for at least 7 days are allowed. Prophylactic antibiotics are allowed.
- •7. Pregnancy or lactation.
- •8. Known hypersensitivity to any of the components of the investigational agent, Selitrectinib or Ora-Sweet® SF and OraPlus®, for patients who will receive Selitrectinib suspension.
- •9. Known history of human immunodeficiency virus (HIV) infection. If previous test was collected more than 3 months prior to the first dose of study drug, then a new test must be performed up to 28 days prior to the study drug start using a blood test for HIV according to local regulations.
- •10. Hepatitis B (HBV) or C (HCV) infection. If previous test was collected more than 3 months prior to the first dose of study drug, then a new test must be performed screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel.
- •a. Patients positive for hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy.
- •b. Patients positive for anti-HCV antibody will be eligible if they are negative for HCVRNA.
- •11. Any malabsorption condition.
- •12. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
研究者
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