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

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En resumen

Observacional150 participantes buscados76 centros26 países

Categorías

Oncología100%

Registrado en 1 registro

ClinicalTrials.govNCT04142437Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses

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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.

Resumen

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.

Afecciones

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	No indicado en el registro
Voluntarios sanos	No
Método de muestreo	NON_PROBABILITY_SAMPLE

Población del estudio

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

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	Observacional
Fase	No indicado en el registro
Asignación	No indicado en el registro
Modelo de intervención	No indicado en el registro
Propósito principal	No indicado en el registro
Enmascaramiento	No indicado en el registro
Inscripción	150 participantes buscados

Patrocinador y colaboradores

Bayer Patrocinador

Grupos e intervenciones

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

Intervenciones

Fármaco 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

Variables de resultado

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

Fechas

Fechas
Fecha de inicio	3 de abril de 2020 (real)
Finalización principal	30 de noviembre de 2029 (estimada)
Finalización	31 de marzo de 2030 (estimada)
Primera publicación	29 de octubre de 2019 (real)
Última actualización	7 de julio de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	julio de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

27 centros están en reclutamiento

Argentina

Argentina
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Australia

Australia
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

Austria

Austria
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Belgium

Belgium
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Brazil

Brazil
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Completado

China

China
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Denmark

Denmark
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

Finland

Finland
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

France

France
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Germany

Germany
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Greece

Greece
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

Ireland

Ireland
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

Italy

Italy
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Japan

Japan
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

Luxembourg

Luxembourg
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Norway

Norway
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

Russia

Russia
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

Singapore

Singapore
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

South Korea

South Korea
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Spain

Spain
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Sweden

Sweden
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Switzerland

Switzerland
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Activo, sin reclutar

Taiwan

Taiwan
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

United Kingdom

United Kingdom
Centro	Ciudad	Estado o región	Estado
Many Locations	Multiple Locations		Retirado

United States

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

En el registro figuran 26 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

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