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

Official Title

PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

Summary:

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated 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. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumour. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumour with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

Trial Description

Primary Outcome:

  • Number of participants with treatment-emergent adverse events (TEAEs)
  • Severity of TEAEs
  • Seriousness of TEAEs
  • Outcome of TEAEs
  • Causality of TEAEs
  • Action taken related to larotrectinib treatment
Secondary Outcome:
  • Objective response rate (ORR)
  • Disease control rate (DCR)
  • Duration of response (DOR)
  • Time to response (TTR)
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Total dose
  • Starting and ending dose
  • Dose modification during treatment
  • Duration of treatment (DOT)
  • ORR by patient subgroup(s)
  • DCR by patient subgroup(s)
  • DOR by patient subgroup(s)
  • TTR by patient subgroup(s)
  • PFS by patient subgroup(s)
  • OS by patient subgroup(s)
  • Number of patients with abnormal neurological assessments
  • Change in height and weight from baseline by visit
  • Number of patients with abnormal developmental milestones
  • Number of patients with abnormal Tanner stage

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society