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
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
Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
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
You may not be if
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
Clareo Health | 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