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

Résumé

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 tumor. 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 tumor 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.

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   Number of participants with treatment-emergent adverse events (TEAEs)

   Délai Up to 30 days after last dose

2. Critère de jugement principal

   Severity of TEAEs

   Délai Up to 30 days after last dose

3. Critère de jugement principal

   Seriousness of TEAEs

   Délai Up to 30 days after last dose

4. Critère de jugement principal

   Reasonable causal relationship between larotrectinib and an AE

   Délai Up to 30 days after last dose

5. Critère de jugement principal

   Causality of TEAEs

   Délai Up to 30 days after last dose

6. Critère de jugement principal

   Action taken related to larotrectinib treatment

   Délai Up to 30 days after last dose

7. Critère de jugement secondaire

   Objective response rate (ORR)

   Délai Up to 8 years

8. Critère de jugement secondaire

   Disease control rate (DCR)

   Délai Up to 8 years

9. Critère de jugement secondaire

   Duration of response (DOR)

   Délai Up to 8 years

10. Critère de jugement secondaire

    Time to response (TTR)

    Délai Up to 8 years

11. Critère de jugement secondaire

    Progression-free survival (PFS)

    Délai Up to 8 years

12. Critère de jugement secondaire

    Overall survival (OS)

    Délai Up to 8 years

13. Critère de jugement secondaire

    Total dose

    Délai Up to 8 years

14. Critère de jugement secondaire

    Starting and ending dose

    Délai Up to 8 years

15. Critère de jugement secondaire

    Dose modification during treatment

    Délai Up to 8 years

16. Critère de jugement secondaire

    Duration of treatment (DOT)

    Délai Up to 8 years

17. Critère de jugement secondaire

    ORR by patient subgroup(s)

    Délai Up to 8 years

18. Critère de jugement secondaire

    DCR by patient subgroup(s)

    Délai Up to 8 years

19. Critère de jugement secondaire

    DOR by patient subgroup(s)

    Délai Up to 8 years

20. Critère de jugement secondaire

    TTR by patient subgroup(s)

    Délai Up to 8 years

21. Critère de jugement secondaire

    PFS by patient subgroup(s)

    Délai Up to 8 years

22. Critère de jugement secondaire

    OS by patient subgroup(s)

    Délai Up to 8 years

23. Critère de jugement secondaire

    Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)

    for all patients

    Délai Up to 8 years

24. Critère de jugement secondaire

    Number of patients with abnormal developmental milestones

    Pediatric cohort only

    Délai Up to 8 years

25. Critère de jugement secondaire

    Number of patients with abnormal Tanner stage

    Pediatric cohort only

    Délai Up to 8 years

Dates

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Lieux

27 sites sont en recrutement

26 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

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Évolution au fil du temps

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