EUCTR2017-004246-20-DE进行中（未招募）1 期
A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects with Previously Treated NTRK Fusion CancersFormerly: 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 the willingness to sign a written informed
- •consent. A signed informed consent must be obtained prior to any studyspecific
- •procedures. Parent/guardian of child or adolescent subjects has
- •the ability to understand, agree to, and sign the study Informed Consent
- •Form and applicable Pediatric 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. 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
- •A list of agents with known TRK inhibitor activity is provided in Appendix
- •A. Other agents not listed may also be considered upon Sponsor review.
- •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. Acceptable methods of
- •detection of NTRK fusion include next-generation sequencing (NGS),
- •fluorescence in situ hybridization (FISH), real-time polymerase chain
- •reaction (RT-PCR) with the following documented in a written report:
- •For NGS, the report indicates that a fusion was detected between an
- •NTRK gene (NTRK1, NTRK2, or NTRK3) and a specific partner gene.
- •For FISH, the report indicates that a probe mapping to an NTRK gene
- •(NTRK1, NTRK2, or NTRK3) and/or a probe mapping to a specific partner
- •gene were found to be colocalized by microscopy.
- •For RT-PCR, the report indicates that a pair of primers targeting an
- •NTRK gene (NTRK1, NTRK2, or NTRK3) on one end and a specific partner
- •gene on the other end amplified a detectable target.
- •If enrolling a patient based on the pan-TRK IHC result, documentation of
- •NTRK fusion must be provided using NGS. If enrolling a patient based on
- •FISH result, additional documentation of NTRK fusion using NGS is
- •Exception: Patients with infantile fibrosarcoma (IFS) or congenital
- •mesoblastic nephroma (CMN) may be enrolled based on confirmation of
- •an ETV6 aberration without an identified partner gene (for example,
- •patients may have been diagnosed with IFS or CMN based on an ETV6+
- •FISH test without identifying [or testing] for NTRK3).
- •4. Performance Status: Eastern Cooperative Oncology Group (ECOG)
- •score = 2 (in adults), Karnofsky Performance Status (KPS) = 50% (age
- •= 16 years) or Lansky Performance Score (LPS) = 50% (age < 16
- •5. Evaluable and/or measurable disease by RECIST v1.1, RANO or
- •International Neuroblastoma Response Criteria (INRC).
- •6. Life expectancy of at least 3 months.
- •7. At least 1 month of age.
- •8. Tissue submission. Samples from 2 time points are required if
- •a. Tumor sample obtained after patient progression on therapy with last
- •kinase inhibitor with anti TRK activity prior to consenting for this trial. A
- 另有 5 项未显示
排除标准
- •1. Prior exposure to second generation TRK inhibitor (e.g. selitrectinib,
- •repotrectinib (TPX-0005), 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
- •3. Concurrent treatment with a strong CYP3A4 inhibitor or inducer (refer
- •to Appendix B), 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 QT interval corrected for heart rate (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 New York
- •Heart Association (NYHA) classification should be functional capacity I
- •at maximum (APPENDIX J).
- •5. Major surgery within 7 days of enrollment. Catheter placement,
- •endoscopic procedures, and dental surgery are not considered major
- •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 take the selitrectinib suspension. Please refer to
- •Appendix G for the complete list of ingredients for Ora-Sweet® SF and
- •Ora-Plus®.
- •9. Known history of human immunodeficiency virus (HIV). Refer to
- •Section 4.2 Exclusion Criteria of the protocol for additional details.
- •10. Hepatitis B (HBV) or C (HCV) infection. Refer to Section 4.2 Exclusion
- •Criteria of the protocol for additional details.
- •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.
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