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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Osservazionale150 partecipanti ricercati76 centri26 paesi

Categorie

Oncologia100%

Registrato in 1 registro

ClinicalTrials.govNCT04142437Apri questa scheda su ClinicalTrials.govSincronizzato 2 mesi fa

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

Ti interessa questo studio?

Accedi oppure crea un account per registrare il tuo interesse e seguire questo studio.

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.

Sintesi

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.

Patologie

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Idoneità

Idoneità
Sesso	Tutti
Età	Non indicato nella scheda del registro
Volontari sani	No
Metodo di campionamento	NON_PROBABILITY_SAMPLE

Popolazione dello studio

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

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Osservazionale
Fase	Non indicato nella scheda del registro
Assegnazione	Non indicato nella scheda del registro
Modello di intervento	Non indicato nella scheda del registro
Finalità principale	Non indicato nella scheda del registro
Mascheramento	Non indicato nella scheda del registro
Arruolamento	150 partecipanti ricercati

Sponsor e collaboratori

Bayer Sponsor

Bracci e interventi

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

Interventi

Farmaco 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

Esiti misurati

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

Date

Date
Data di inizio	3 aprile 2020 (effettiva)
Conclusione primaria	30 novembre 2029 (stimata)
Conclusione	31 marzo 2030 (stimata)
Prima pubblicazione	29 ottobre 2019 (effettiva)
Ultimo aggiornamento	7 luglio 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	luglio 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

27 centri stanno reclutando

Argentina

Argentina
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Australia

Australia
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

Austria

Austria
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Belgium

Belgium
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Brazil

Brazil
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

Canada

Canada
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Completato

China

China
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Denmark

Denmark
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

Finland

Finland
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

France

France
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Germany

Germany
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Greece

Greece
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

Ireland

Ireland
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

Italy

Italy
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Japan

Japan
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

Luxembourg

Luxembourg
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Norway

Norway
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

Russia

Russia
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

Singapore

Singapore
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

South Korea

South Korea
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Spain

Spain
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Sweden

Sweden
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Switzerland

Switzerland
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Attivo, non in reclutamento

Taiwan

Taiwan
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

United Kingdom

United Kingdom
Struttura	Città	Stato o regione	Stato
Many Locations	Multiple Locations		Ritirato

United States

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

Nella scheda del registro sono indicati altri 26 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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