Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

Overview

Información sobre este estudio

The purpose of this study is to describe, under real-world conditions, the safety and effectiveness of larotrectinib in patients with locally advanced or metastaticTRK fusion cancer for whom a decision to treat with larotrectinib has been made before enrollment.

 

 

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Adult and pediatric (from birth to 18 year old) patients.
  • Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above. 
  • Life expectancy of at least 3 months based on clinical judgement.
  • Decision to treat with larotrectinib made by the treating physician prior to study enrollment.
  • Signed informed consent form.
  • For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required.

Exclusion Criteria:

  • Any contraindications as listed in the local approved product information.
  • Pregnancy.
  • Participation in an investigational program with interventions outside of routine clinical practice.
  • Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition.
  • Patients with NTRK gene amplification or NTRK point mutation.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Scott Okuno, M.D.

Cerrado para la inscripción

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Steven Attia, D.O.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20486007

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