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 (ON-TRK)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2030
  • participants needed
    300
  • sponsor
    Bayer
Updated on 4 June 2022

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 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.

Details
Condition Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
Treatment larotrectinib(Vitrakvi, BAY2757556)
Clinical Study IdentifierNCT04142437
SponsorBayer
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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