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NCT04142437Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
54 (actual)
First submitted
17 Oct 2019
Start date
Apr 2020
Primary completion date
Dec 2029
Lead sponsor
Bayer
NCT number
NCT04142437

What you commit to

  • Study type: Observational
  • Participants enrolled: 54
  • From Apr 2020 to the primary completion date, Dec 2029
  • 47 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition

Other

  • Any contraindications as listed in the local approved product information
  • Pregnancy
  • Participation in an investigational program with interventions outside of routine clinical practice
  • Patients with NTRK gene amplification or NTRK point mutation

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Many Locations
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Many LocationsArgentinaUnknown status
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Many LocationsAustriaUnknown status
Many Locations
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Many LocationsBelgiumUnknown status
Many Locations
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Many LocationsCanadaUnknown status
Many Locations
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Many LocationsSwitzerlandUnknown status
Many Locations
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Many LocationsChinaUnknown status
Many Locations
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Many LocationsGermanyUnknown status
Many Locations
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Many LocationsSpainUnknown status
Many Locations
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Many LocationsFinlandUnknown status
Many Locations
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Many LocationsFranceUnknown status
Many Locations
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Many LocationsItalyUnknown status
Many Locations
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Many LocationsSouth KoreaUnknown status
Many Locations
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Many LocationsLuxembourgUnknown status
Many Locations
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Many LocationsSwedenUnknown status
Johns Hopkins / Sidney Kimmel Cancer Center
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BaltimoreUnited StatesUnknown status
Tufts / Neely Cancer Center
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BostonUnited StatesUnknown status
Great Lakes Cancer Center
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BuffaloUnited StatesUnknown status
Medical Univ. of South Carolina
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CharlestonUnited StatesUnknown status
UT Southwestern Medical Center / Children's Health
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DallasUnited StatesUnknown status
Detroit Clinical Research Center
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Farmington HillsUnited StatesUnknown status
Fort Wayne Medical Oncology & Hematology
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Fort WayneUnited StatesUnknown status
Frederick Health- James M Stockman Cancer Institute
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FrederickUnited StatesUnknown status
East Carolina University / Vidant Health
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GreenvilleUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Gundersen Health System
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La CrosseUnited StatesUnknown status
Sparrow Cancer Center
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LansingUnited StatesUnknown status
Nevada Cancer Research Foundation
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Las VegasUnited StatesUnknown status
UCLA Mattel Children's Hospital
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Los AngelesUnited StatesUnknown status
California Research Inst.
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Los AngelesUnited StatesUnknown status
SSM Health Cancer Center - Dean Medical Group
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MadisonUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
Nicklaus Children's Hospital
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MiamiUnited StatesUnknown status
West Virginia University
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MorgantownUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
Hoag Memorial Hospital Presbyterian
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Newport BeachUnited StatesUnknown status
Memorial Sloan Kettering Children's Cancer Center
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New YorkUnited StatesUnknown status
Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
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Palo AltoUnited StatesUnknown status
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesUnknown status
Allegheny Health Network
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PittsburghUnited StatesUnknown status
Univ. of Utah / Huntsman Cancer Center
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Salt Lake CityUnited StatesUnknown status
Providence Health System - Southern California
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Santa MonicaUnited StatesUnknown status
Seattle Children's
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SeattleUnited StatesUnknown status
Maine Health
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South PortlandUnited StatesUnknown status
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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TorranceUnited StatesUnknown status
Cancer Center of Kansas
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WichitaUnited StatesUnknown status
Mercy Health Youngstown
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YoungstownUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.