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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

Beobachtend150 Teilnehmende gesucht76 Studienzentren26 Länder

Kategorien

Onkologie100%

In 1 Register registriert

ClinicalTrials.govNCT04142437Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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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.

Zusammenfassung

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.

Erkrankungen

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Eignung

Eignung
Geschlecht	Alle
Alter	Im Registereintrag nicht angegeben
Gesunde Freiwillige	Nein
Stichprobenverfahren	NON_PROBABILITY_SAMPLE

Studienpopulation

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

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Beobachtend
Phase	Im Registereintrag nicht angegeben
Zuteilung	Im Registereintrag nicht angegeben
Interventionsmodell	Im Registereintrag nicht angegeben
Primäres Ziel	Im Registereintrag nicht angegeben
Verblindung	Im Registereintrag nicht angegeben
Teilnahme	150 Teilnehmende gesucht

Sponsor und Mitwirkende

Bayer Sponsor

Studienarme und Interventionen

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

Interventionen

Arzneimittel 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

Endpunkte

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

Daten

Daten
Startdatum	3. April 2020 (tatsächlich)
Primärer Abschluss	30. November 2029 (geschätzt)
Abschluss	31. März 2030 (geschätzt)
Erstveröffentlichung	29. Oktober 2019 (tatsächlich)
Zuletzt aktualisiert	7. Juli 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juli 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

27 Studienzentren rekrutieren

Argentina

Argentina
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

Austria

Austria
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Belgium

Belgium
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Brazil

Brazil
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Abgeschlossen

China

China
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Denmark

Denmark
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

Finland

Finland
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

France

France
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Germany

Germany
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Greece

Greece
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

Ireland

Ireland
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

Italy

Italy
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Japan

Japan
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

Luxembourg

Luxembourg
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Norway

Norway
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

Russia

Russia
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

Singapore

Singapore
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

South Korea

South Korea
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Spain

Spain
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Sweden

Sweden
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Switzerland

Switzerland
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Aktiv, rekrutiert nicht

Taiwan

Taiwan
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

United Kingdom

United Kingdom
Einrichtung	Stadt	Bundesland oder Region	Status
Many Locations	Multiple Locations		Zurückgezogen

United States

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

26 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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