NCT04142437ClinicalTrials.gov

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

RecruitingTaking participants now, according to the registry record.

Contact this study

In brief

Observational150 participants sought76 sites26 countries

Registered in 1 registry

ClinicalTrials.govNCT04142437Open this record at ClinicalTrials.govSynced 2 months ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2019-10-29; recorded start 2020-04-03
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 203 other studies in this databaseCounted from the lead sponsor named in the record (Bayer)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Masking not stated in the record
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 76 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 150 participants (target), run at 76 sites, across 26 countries.

How this score is built

Enrolment21/40
150 participants (target)
Site count22/25
76 sites
Country count15/15
26 countries
Planned duration10/10
Planned over about 122 months
Sponsor scale9/10
Bayer has led 201 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

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.

Conditions

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Eligibility

Eligibility
Sex	All
Ages	Not stated in the registry record
Healthy volunteers	No
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

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Observational
Phase	Not stated in the registry record
Allocation	Not stated in the registry record
Intervention model	Not stated in the registry record
Primary purpose	Not stated in the registry record
Masking	Not stated in the registry record
Enrolment	150 participants sought

Sponsor and collaborators

Bayer Sponsor

Arms and interventions

GI
adult patients with gastrointestinal (GI) cancer
H&N
adult patients with head and neck (H\&N) cancer
STS
adult patients with soft tissue sarcoma (STS)
CNS
adult patients with primary central nervous system (CNS) cancer
Lung
adult patients with lung cancer
Melanoma
adult patients with melanoma
Pediatric
all pediatric patients regardless of tumor type will be enrolled under this cohort
other
patients with other tumor types

Interventions

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

Outcome measures

Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame Up to 30 days after last dose
Primary outcome
Severity of TEAEs
Time frame Up to 30 days after last dose
Primary outcome
Seriousness of TEAEs
Time frame Up to 30 days after last dose
Primary outcome
Reasonable causal relationship between larotrectinib and an AE
Time frame Up to 30 days after last dose
Primary outcome
Causality of TEAEs
Time frame Up to 30 days after last dose
Primary outcome
Action taken related to larotrectinib treatment
Time frame Up to 30 days after last dose
Secondary outcome
Objective response rate (ORR)
Time frame Up to 8 years
Secondary outcome
Disease control rate (DCR)
Time frame Up to 8 years
Secondary outcome
Duration of response (DOR)
Time frame Up to 8 years
Secondary outcome
Time to response (TTR)
Time frame Up to 8 years
Secondary outcome
Progression-free survival (PFS)
Time frame Up to 8 years
Secondary outcome
Overall survival (OS)
Time frame Up to 8 years
Secondary outcome
Total dose
Time frame Up to 8 years
Secondary outcome
Starting and ending dose
Time frame Up to 8 years
Secondary outcome
Dose modification during treatment
Time frame Up to 8 years
Secondary outcome
Duration of treatment (DOT)
Time frame Up to 8 years
Secondary outcome
ORR by patient subgroup(s)
Time frame Up to 8 years
Secondary outcome
DCR by patient subgroup(s)
Time frame Up to 8 years
Secondary outcome
DOR by patient subgroup(s)
Time frame Up to 8 years
Secondary outcome
TTR by patient subgroup(s)
Time frame Up to 8 years
Secondary outcome
PFS by patient subgroup(s)
Time frame Up to 8 years
Secondary outcome
OS by patient subgroup(s)
Time frame Up to 8 years
Secondary outcome
Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
for all patients
Time frame Up to 8 years
Secondary outcome
Number of patients with abnormal developmental milestones
Pediatric cohort only
Time frame Up to 8 years
Secondary outcome
Number of patients with abnormal Tanner stage
Pediatric cohort only
Time frame Up to 8 years

Dates

Dates
Start date	April 3, 2020 (actual)
Primary completion	November 30, 2029 (estimated)
Completion	March 31, 2030 (estimated)
First posted	October 29, 2019 (actual)
Last updated	July 7, 2026
Results posted	Not stated in the registry record
Status last verified	July 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

27 sites are recruiting

Argentina

Argentina
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Australia

Australia
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

Austria

Austria
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Belgium

Belgium
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Brazil

Brazil
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

Canada

Canada
Facility	City	State or region	Status
Many Locations	Multiple Locations		Completed

China

China
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Denmark

Denmark
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

Finland

Finland
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

France

France
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Germany

Germany
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Greece

Greece
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

Ireland

Ireland
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

Italy

Italy
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Japan

Japan
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

Luxembourg

Luxembourg
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Norway

Norway
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

Russia

Russia
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

Singapore

Singapore
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

South Korea

South Korea
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Spain

Spain
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Sweden

Sweden
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Switzerland

Switzerland
Facility	City	State or region	Status
Many Locations	Multiple Locations		Active, not recruiting

Taiwan

Taiwan
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

United Kingdom

United Kingdom
Facility	City	State or region	Status
Many Locations	Multiple Locations		Withdrawn

United States

United States
Facility	City	State or region	Status
Univ. of Maryland / Greenebaum Comp. Cancer Ctr.	Baltimore	Maryland	Withdrawn
Johns Hopkins / Sidney Kimmel Cancer Center	Baltimore	Maryland	Recruiting
Tufts / Neely Cancer Center	Boston	Massachusetts	Recruiting
Boston Children's / Dana Farber	Boston	Massachusetts	Withdrawn
Great Lakes Cancer Center	Buffalo	New York	Terminated
Medical Univ. of South Carolina	Charleston	South Carolina	Recruiting
Levine Cancer Center	Charlotte	North Carolina	Withdrawn
Ohio State Comp. Cancer Ctr. / James Cancer Hospital	Columbus	Ohio	Withdrawn
UT Southwestern Medical Center / Children's Health	Dallas	Texas	Recruiting
Detroit Clinical Research Center	Farmington Hills	Michigan	Recruiting
Fort Wayne Medical Oncology Hematology	Fort Wayne	Indiana	Recruiting
Frederick Health-James M Stockman Cancer Institute	Frederick	Maryland	Terminated
SCL Health	Grand Junction	Colorado	Withdrawn
East Carolina University / Vidant Health	Greenville	North Carolina	Recruiting
MD Anderson Cancer Center	Houston	Texas	Recruiting
Mayo Clinic	Jacksonville	Florida	Withdrawn
Gundersen Health System	La Crosse	Wisconsin	Recruiting
Sparrow Cancer Center	Lansing	Michigan	Recruiting
Nevada Cancer Research Foundation	Las Vegas	Nevada	Recruiting
California Research Inst.	Los Angeles	California	Recruiting
USC / Norris Comprehensive Cancer Center	Los Angeles	California	Withdrawn
UCLA - Mattel Children's Hospital	Los Angeles	California	Recruiting
SSM Health Cancer Center - Dean Medical Group	Madison	Wisconsin	Terminated
St. Jude Children's Research Hospital	Memphis	Tennessee	Withdrawn
Banner Desert Medical Center	Mesa	Arizona	Withdrawn

26 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT04142437

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Study population

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Australia

Austria

Belgium

Brazil

Canada

China

Denmark

Finland

France

Germany

Greece

Ireland

Italy

Japan

Luxembourg

Norway

Russia

Singapore

South Korea

Spain

Sweden

Switzerland

Taiwan

United Kingdom

United States

Study documents

Changes over time