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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

رصديةمطلوب 150 مشاركاً76 موقعاً26 دولة

الفئات

علم الأورام100%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

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

ملخص

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.

الحالات

  • Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

الأهلية

الجنسالجميع
الأعمارغير مذكور في سجل السجل
المتطوعون الأصحّاءلا
طريقة أخذ العيناتNON_PROBABILITY_SAMPLE

مجتمع الدراسة

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

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةرصدية
المرحلةغير مذكور في سجل السجل
التخصيصغير مذكور في سجل السجل
نموذج التدخّلغير مذكور في سجل السجل
الغرض الأساسيغير مذكور في سجل السجل
التعميةغير مذكور في سجل السجل
التجنيدمطلوب 150 مشاركاً

الجهة الراعية والمتعاونون

  • Bayer الجهة الراعية

الأذرع والتدخلات

  • 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

التدخلات

  • دواء 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

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Number of participants with treatment-emergent adverse events (TEAEs)

    الإطار الزمني Up to 30 days after last dose

  2. مقياس النتيجة الأولي

    Severity of TEAEs

    الإطار الزمني Up to 30 days after last dose

  3. مقياس النتيجة الأولي

    Seriousness of TEAEs

    الإطار الزمني Up to 30 days after last dose

  4. مقياس النتيجة الأولي

    Reasonable causal relationship between larotrectinib and an AE

    الإطار الزمني Up to 30 days after last dose

  5. مقياس النتيجة الأولي

    Causality of TEAEs

    الإطار الزمني Up to 30 days after last dose

  6. مقياس النتيجة الأولي

    Action taken related to larotrectinib treatment

    الإطار الزمني Up to 30 days after last dose

  7. مقياس النتيجة الثانوي

    Objective response rate (ORR)

    الإطار الزمني Up to 8 years

  8. مقياس النتيجة الثانوي

    Disease control rate (DCR)

    الإطار الزمني Up to 8 years

  9. مقياس النتيجة الثانوي

    Duration of response (DOR)

    الإطار الزمني Up to 8 years

  10. مقياس النتيجة الثانوي

    Time to response (TTR)

    الإطار الزمني Up to 8 years

  11. مقياس النتيجة الثانوي

    Progression-free survival (PFS)

    الإطار الزمني Up to 8 years

  12. مقياس النتيجة الثانوي

    Overall survival (OS)

    الإطار الزمني Up to 8 years

  13. مقياس النتيجة الثانوي

    Total dose

    الإطار الزمني Up to 8 years

  14. مقياس النتيجة الثانوي

    Starting and ending dose

    الإطار الزمني Up to 8 years

  15. مقياس النتيجة الثانوي

    Dose modification during treatment

    الإطار الزمني Up to 8 years

  16. مقياس النتيجة الثانوي

    Duration of treatment (DOT)

    الإطار الزمني Up to 8 years

  17. مقياس النتيجة الثانوي

    ORR by patient subgroup(s)

    الإطار الزمني Up to 8 years

  18. مقياس النتيجة الثانوي

    DCR by patient subgroup(s)

    الإطار الزمني Up to 8 years

  19. مقياس النتيجة الثانوي

    DOR by patient subgroup(s)

    الإطار الزمني Up to 8 years

  20. مقياس النتيجة الثانوي

    TTR by patient subgroup(s)

    الإطار الزمني Up to 8 years

  21. مقياس النتيجة الثانوي

    PFS by patient subgroup(s)

    الإطار الزمني Up to 8 years

  22. مقياس النتيجة الثانوي

    OS by patient subgroup(s)

    الإطار الزمني Up to 8 years

  23. مقياس النتيجة الثانوي

    Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)

    for all patients

    الإطار الزمني Up to 8 years

  24. مقياس النتيجة الثانوي

    Number of patients with abnormal developmental milestones

    Pediatric cohort only

    الإطار الزمني Up to 8 years

  25. مقياس النتيجة الثانوي

    Number of patients with abnormal Tanner stage

    Pediatric cohort only

    الإطار الزمني Up to 8 years

التواريخ

تاريخ البدء3 أبريل 2020 (فعلي)
الإتمام الأولي30 نوفمبر 2029 (تقديري)
الإتمام31 مارس 2030 (تقديري)
أول نشر29 أكتوبر 2019 (فعلي)
آخر تحديث7 يوليو 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيوليو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

27 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمسحوب

Austria

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمسحوب

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمكتمل

China

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Denmark

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمسحوب

Finland

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

France

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Germany

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Greece

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمسحوب

Ireland

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمسحوب

Italy

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Japan

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمسحوب

Luxembourg

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Norway

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمسحوب

Russia

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمسحوب

Singapore

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Many LocationsMultiple Locationsمسحوب

South Korea

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Spain

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Sweden

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Switzerland

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsنشط، دون تجنيد

Taiwan

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمسحوب

United Kingdom

المنشأةالمدينةالولاية أو المنطقةالحالة
Many LocationsMultiple Locationsمسحوب

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Univ. of Maryland / Greenebaum Comp. Cancer Ctr.BaltimoreMarylandمسحوب
Johns Hopkins / Sidney Kimmel Cancer CenterBaltimoreMarylandقيد التجنيد
Tufts / Neely Cancer CenterBostonMassachusettsقيد التجنيد
Boston Children's / Dana FarberBostonMassachusettsمسحوب
Great Lakes Cancer CenterBuffaloNew Yorkأُنهي
Medical Univ. of South CarolinaCharlestonSouth Carolinaقيد التجنيد
Levine Cancer CenterCharlotteNorth Carolinaمسحوب
Ohio State Comp. Cancer Ctr. / James Cancer HospitalColumbusOhioمسحوب
UT Southwestern Medical Center / Children's HealthDallasTexasقيد التجنيد
Detroit Clinical Research CenterFarmington HillsMichiganقيد التجنيد
Fort Wayne Medical Oncology HematologyFort WayneIndianaقيد التجنيد
Frederick Health-James M Stockman Cancer InstituteFrederickMarylandأُنهي
SCL HealthGrand JunctionColoradoمسحوب
East Carolina University / Vidant HealthGreenvilleNorth Carolinaقيد التجنيد
MD Anderson Cancer CenterHoustonTexasقيد التجنيد
Mayo ClinicJacksonvilleFloridaمسحوب
Gundersen Health SystemLa CrosseWisconsinقيد التجنيد
Sparrow Cancer CenterLansingMichiganقيد التجنيد
Nevada Cancer Research FoundationLas VegasNevadaقيد التجنيد
California Research Inst.Los AngelesCaliforniaقيد التجنيد
USC / Norris Comprehensive Cancer CenterLos AngelesCaliforniaمسحوب
UCLA - Mattel Children's HospitalLos AngelesCaliforniaقيد التجنيد
SSM Health Cancer Center - Dean Medical GroupMadisonWisconsinأُنهي
St. Jude Children's Research HospitalMemphisTennesseeمسحوب
Banner Desert Medical CenterMesaArizonaمسحوب

يُدرَج 26 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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