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NCT Number: NCT04142437

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

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.

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Key information

Conditions

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Multiple Locations, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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

Treatment and study plan

larotrectinib(Vitrakvi, BAY2757556)

Drug

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol

Primary outcomes

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

    Time frame: Up to 30 days after last dose

  2. Severity of TEAEs

    Time frame: Up to 30 days after last dose

  3. Seriousness of TEAEs

    Time frame: Up to 30 days after last dose

  4. Reasonable causal relationship between larotrectinib and an AE

    Time frame: Up to 30 days after last dose

  5. Causality of TEAEs

    Time frame: Up to 30 days after last dose

  6. Action taken related to larotrectinib treatment

    Time frame: Up to 30 days after last dose

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 8 years

  2. Disease control rate (DCR)

    Time frame: Up to 8 years

  3. Duration of response (DOR)

    Time frame: Up to 8 years

  4. Time to response (TTR)

    Time frame: Up to 8 years

  5. Progression-free survival (PFS)

    Time frame: Up to 8 years

  6. Overall survival (OS)

    Time frame: Up to 8 years

  7. Total dose

    Time frame: Up to 8 years

  8. Starting and ending dose

    Time frame: Up to 8 years

  9. Dose modification during treatment

    Time frame: Up to 8 years

  10. Duration of treatment (DOT)

    Time frame: Up to 8 years

  11. ORR by patient subgroup(s)

    Time frame: Up to 8 years

  12. DCR by patient subgroup(s)

    Time frame: Up to 8 years

  13. DOR by patient subgroup(s)

    Time frame: Up to 8 years

  14. TTR by patient subgroup(s)

    Time frame: Up to 8 years

  15. PFS by patient subgroup(s)

    Time frame: Up to 8 years

  16. OS by patient subgroup(s)

    Time frame: Up to 8 years

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

    Time frame: Up to 8 years

    for all patients

  18. Number of patients with abnormal developmental milestones

    Time frame: Up to 8 years

    Pediatric cohort only

  19. Number of patients with abnormal Tanner stage

    Time frame: Up to 8 years

    Pediatric cohort only

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: ON-TRK

Important dates

Study start
2020
Primary completion
2029
Study completion
2030
First posted
Oct 29, 2019
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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