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

  • Study HIC#:2000026442
  • Last Updated:12/29/2023

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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    Trial Purpose and Description

    Primary Outcome Measures  :

    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. Outcome of TEAEs [ 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 ]

    Eligibility Criteria

    Study Population

    Adult and pediatric (from birth to 18 year old) patients with a locally advanced or metastatic solid tumor harboring an NTRK gene fusion (detected by NGS (Next-Generation Sequencing), FISH (Fluorescent In Situ Hybridization), rt-PCR (Reverse Transcription Polymerase Chain Reaction) or other genomic testing able to detect NTRK gene fusion) assessed locally for whom a decision to treat with larotrectinib has been made by the treating physician prior to or at the time of study enrollment

    Criteria

    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

    For more information about this study, including how to volunteer, contact: