Back to search results

Observational Study of VITRAKVI for TRK Fusion Cancer

This observational study is learning more about how well VITRAKVI (larotrectinib) works and is tolerated in patients with TRK fusion cancer during routine care. TRK fusion cancer is a type of cancer caused by a change in the NTRK gene, which leads to the growth of tumors. VITRAKVI is an approved drug that blocks this gene change. You may be able to join if you are an adult or child with locally advanced or metastatic solid tumor that has an NTRK gene fusion. The study will look at side effects, their severity, and seriousness up to 30 days after your last dose. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 150 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events up to 30 days after their last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
Not specifiedAll AgesObservational
Bayer
~150 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:larotrectinib(Vitrakvi, BAY2757556)

At a glance

Recruiting sites
27 of 76 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs)
Measured over Up to 30 days after last dose
+5 more outcomes measured

Conditions

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Explore related trials

Solid NeoplasmNTRK Family Gene

NCT04142437

Where you'd take part

This study runs at 76 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • California Research Inst.

    Los Angeles, Californiano site contact published

    Recruiting

  • Cancer Center of Kansas

    Wichita, Kansasno site contact published

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniano site contact published

    Recruiting

  • Detroit Clinical Research Center

    Farmington Hills, Michiganno site contact published

    Recruiting

  • East Carolina University / Vidant Health

    Greenville, North Carolinano site contact published

    Recruiting

  • Fort Wayne Medical Oncology Hematology

    Fort Wayne, Indianano site contact published

    Recruiting

  • Gundersen Health System

    La Crosse, Wisconsinno site contact published

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Bayer Clinical Trials Contact
[email protected]
(+)1-888-84 22937
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with treatment-emergent adverse events (TEAEs)Up to 30 days after last dose
  • Severity of TEAEsUp to 30 days after last dose
  • Seriousness of TEAEsUp to 30 days after last dose
  • Reasonable causal relationship between larotrectinib and an AEUp to 30 days after last dose
  • Causality of TEAEsUp to 30 days after last dose
  • Action taken related to larotrectinib treatmentUp to 30 days after last dose