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New study tracks how well larotrectinib works in everyday cancer care

NCT ID NCT04142437

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study follows 150 adults and children with advanced TRK fusion cancers who are already taking the drug larotrectinib (Vitrakvi). Researchers will collect data from routine doctor visits over 2 to 5 years to see how effective the drug is and what side effects occur. The goal is to understand how the drug performs in real-world settings, outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
larotrectinib (Vitrakvi)
What this could lead to
If successful, this study could confirm how well larotrectinib works in everyday practice for people with TRK fusion cancers, supporting its continued use.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only includes people already prescribed the drug, which may introduce bias.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2020

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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 before enrollment

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

NTRK fusion positive cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced or metastatic solid tumor harboring an NTRK gene fusion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny Health Network

    TERMINATED

    Pittsburgh, Pennsylvania, 15212, United States

  • Atlantic Hem Onc / Morristown Medical Center

    WITHDRAWN

    Morristown, New Jersey, 07960, United States

  • Banner Desert Medical Center

    WITHDRAWN

    Mesa, Arizona, 85202, United States

  • Boston Children's / Dana Farber

    WITHDRAWN

    Boston, Massachusetts, 02215, United States

  • California Research Inst.

    RECRUITING

    Los Angeles, California, 90027, United States

  • Cancer Center of Kansas

    RECRUITING

    Wichita, Kansas, 67214, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Detroit Clinical Research Center

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • East Carolina University / Vidant Health

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Fort Wayne Medical Oncology Hematology

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Frederick Health-James M Stockman Cancer Institute

    TERMINATED

    Frederick, Maryland, 21702, United States

  • Great Lakes Cancer Center

    TERMINATED

    Buffalo, New York, 14210, United States

  • Gundersen Health System

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 82663, United States

  • Intermountain Healthcare - Dixie Regional Medical Center

    WITHDRAWN

    St. George, Utah, 84790, United States

  • Intermountain Healthcare - Intermountain Medical Center

    WITHDRAWN

    Murray, Utah, 84107, United States

  • Johns Hopkins / Sidney Kimmel Cancer Center

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Levine Cancer Center

    WITHDRAWN

    Charlotte, North Carolina, 28204, United States

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    WITHDRAWN

    Torrance, California, 90502, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Maine Health

    RECRUITING

    South Portland, Maine, 04106, United States

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, Argentina

  • Many Locations

    WITHDRAWN

    Multiple Locations, Australia

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, Austria

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, Belgium

  • Many Locations

    WITHDRAWN

    Multiple Locations, Brazil

  • Many Locations

    COMPLETED

    Multiple Locations, Canada

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, China

  • Many Locations

    WITHDRAWN

    Multiple Locations, Denmark

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, Finland

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, France

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, Germany

  • Many Locations

    WITHDRAWN

    Multiple Locations, Greece

  • Many Locations

    WITHDRAWN

    Multiple Locations, Ireland

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, Italy

  • Many Locations

    WITHDRAWN

    Multiple Locations, Japan

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, Luxembourg

  • Many Locations

    WITHDRAWN

    Multiple Locations, Norway

  • Many Locations

    WITHDRAWN

    Multiple Locations, Russia

  • Many Locations

    WITHDRAWN

    Multiple Locations, Singapore

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, South Korea

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, Spain

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, Sweden

  • Many Locations

    ACTIVE_NOT_RECRUITING

    Multiple Locations, Switzerland

  • Many Locations

    WITHDRAWN

    Multiple Locations, Taiwan

  • Many Locations

    WITHDRAWN

    Multiple Locations, United Kingdom

  • Mayo Clinic

    WITHDRAWN

    Jacksonville, Florida, 32224, United States

  • Medical Univ. of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering Children's Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Mercy Health Youngstown

    RECRUITING

    Youngstown, Ohio, 44501, United States

  • Nemours Children's Hospital

    WITHDRAWN

    Orlando, Florida, 32827, United States

  • Nevada Cancer Research Foundation

    RECRUITING

    Las Vegas, Nevada, 89169, United States

  • Nicklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Ohio State Comp. Cancer Ctr. / James Cancer Hospital

    WITHDRAWN

    Columbus, Ohio, 43210, United States

  • Providence Health System - Southern California

    TERMINATED

    Santa Monica, California, 90404, United States

  • Regional Health Hope Center

    WITHDRAWN

    Terre Haute, Indiana, 47802, United States

  • Rutgers Cancer Institute of New Jersey

    WITHDRAWN

    New Brunswick, New Jersey, 08901, United States

  • SCL Health

    WITHDRAWN

    Grand Junction, Colorado, 81501, United States

  • SSM Health Cancer Center - Dean Medical Group

    TERMINATED

    Madison, Wisconsin, 53717, United States

  • Seattle Children's

    RECRUITING

    Seattle, Washington, 98105, United States

  • Sparrow Cancer Center

    RECRUITING

    Lansing, Michigan, 48912, United States

  • St. Jude Children's Research Hospital

    WITHDRAWN

    Memphis, Tennessee, 38105, United States

  • Stanford Univ Med Ctr. / Lucile Packard Children's Hosp

    RECRUITING

    Palo Alto, California, 94304, United States

  • Staten Island Univ. Hospital (Northwell Health)

    WITHDRAWN

    Staten Island, New York, 10305, United States

  • Tufts / Neely Cancer Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UCLA - Mattel Children's Hospital

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCSF Benioff Children's Hospital Oakland

    WITHDRAWN

    Oakland, California, 94609, United States

  • USC / Norris Comprehensive Cancer Center

    WITHDRAWN

    Los Angeles, California, 90089, United States

  • UT Southwestern Medical Center / Children's Health

    RECRUITING

    Dallas, Texas, 75390, United States

  • Univ. of Maryland / Greenebaum Comp. Cancer Ctr.

    WITHDRAWN

    Baltimore, Maryland, 21201, United States

  • Univ. of Utah / Huntsman Cancer Center

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33146, United States

  • University of Pennsylvania (Penn Med)

    WITHDRAWN

    Philadelphia, Pennsylvania, 19104, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States