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)

October 21, 2026 updated by: Bayer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Many Locations, Argentina
        • Many Locations
  • Austria
      • Many Locations, Austria
        • Many Locations
  • Belgium
      • Many Locations, Belgium
        • Many Locations
  • Canada
      • Many Locations, Canada
        • Many Locations
  • China
      • Many Locations, China
        • Many Locations
  • Finland
      • Many Locations, Finland
        • Many Locations
  • France
      • Many Locations, France
        • Many Locations
  • Germany
      • Many Locations, Germany
        • Many Locations
  • Italy
      • Many Locations, Italy
        • Many Locations
  • Luxembourg
      • Many Locations, Luxembourg
        • Many Locations
  • South Korea
      • Many Locations, South Korea
        • Many Locations
  • Spain
      • Many Locations, Spain
        • Many Locations
  • Sweden
      • Many Locations, Sweden
        • Many Locations
  • Switzerland
      • Many Locations, Switzerland
        • Many Locations
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA - Mattel Children's Hospital
      • Los Angeles, California, United States, 90027
        • California Research Inst.
      • Newport Beach, California, United States, 82663
        • Hoag Memorial Hospital Presbyterian
      • Palo Alto, California, United States, 94304
        • Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
      • Santa Monica, California, United States, 90404
        • Providence Health System - Southern California
      • Torrance, California, United States, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Florida
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital
      • Miami, Florida, United States, 33146
        • University of Miami
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology Hematology
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Maine
      • South Portland, Maine, United States, 04106
        • Maine Health
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins / Sidney Kimmel Cancer Center
      • Frederick, Maryland, United States, 21702
        • Frederick Health-James M Stockman Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts / Neely Cancer Center
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Detroit Clinical Research Center
      • Lansing, Michigan, United States, 48912
        • Sparrow Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Nevada Cancer Research Foundation
    • New York
      • Buffalo, New York, United States, 14210
        • Great Lakes Cancer Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Children's Cancer Center
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University / Vidant Health
    • Ohio
      • Youngstown, Ohio, United States, 44501
        • Mercy Health Youngstown
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Health Network
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical Univ. of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center / Children's Health
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Univ. of Utah / Huntsman Cancer Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Health System
      • Madison, Wisconsin, United States, 53717
        • SSM Health Cancer Center - Dean Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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 before enrollment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
GI

adult patients with gastrointestinal (GI) cancer
Drug: larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
H&N

adult patients with head and neck (H&N) cancer
Drug: larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
STS

adult patients with soft tissue sarcoma (STS)
Drug: larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
CNS

adult patients with primary central nervous system (CNS) cancer
Drug: larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
Lung

adult patients with lung cancer
Drug: larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
Melanoma

adult patients with melanoma
Drug: larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
Pediatric

all pediatric patients regardless of tumor type will be enrolled under this cohort
Drug: larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
other

patients with other tumor types
Drug: larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to 30 days after last dose
Up to 30 days after last dose
Severity of TEAEs
Time Frame: Up to 30 days after last dose
Up to 30 days after last dose
Seriousness of TEAEs
Time Frame: Up to 30 days after last dose
Up to 30 days after last dose
Causality of TEAEs
Time Frame: Up to 30 days after last dose
Up to 30 days after last dose
Action taken related to larotrectinib treatment
Time Frame: Up to 30 days after last dose
Up to 30 days after last dose
Reasonable causal relationship between larotrectinib and an AE
Time Frame: Up to 30 days after last dose
Up to 30 days after last dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to 8 years
Up to 8 years
Disease control rate (DCR)
Time Frame: Up to 8 years
Up to 8 years
Duration of response (DOR)
Time Frame: Up to 8 years
Up to 8 years
Time to response (TTR)
Time Frame: Up to 8 years
Up to 8 years
Progression-free survival (PFS)
Time Frame: Up to 8 years
Up to 8 years
Overall survival (OS)
Time Frame: Up to 8 years
Up to 8 years
Total dose
Time Frame: Up to 8 years
Up to 8 years
Starting and ending dose
Time Frame: Up to 8 years
Up to 8 years
Dose modification during treatment
Time Frame: Up to 8 years
Up to 8 years
Duration of treatment (DOT)
Time Frame: Up to 8 years
Up to 8 years
ORR by patient subgroup(s)
Time Frame: Up to 8 years
Up to 8 years
DCR by patient subgroup(s)
Time Frame: Up to 8 years
Up to 8 years
DOR by patient subgroup(s)
Time Frame: Up to 8 years
Up to 8 years
TTR by patient subgroup(s)
Time Frame: Up to 8 years
Up to 8 years
PFS by patient subgroup(s)
Time Frame: Up to 8 years
Up to 8 years
OS by patient subgroup(s)
Time Frame: Up to 8 years
Up to 8 years
Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
Time Frame: Up to 8 years

for all patients
Up to 8 years
Number of patients with abnormal developmental milestones
Time Frame: Up to 8 years

Pediatric cohort only
Up to 8 years
Number of patients with abnormal Tanner stage
Time Frame: Up to 8 years

Pediatric cohort only
Up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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