Badanie, aby dowiedzieć się więcej o bezpieczeństwie i skuteczności leku VITRAKVI podczas rutynowego stosowania u pacjentów z rakiem fuzyjnym TRK, który jest miejscowo zaawansowany lub rozprzestrzenia się z miejsca, w którym się pojawił, do innych miejsc w ciele (ON-TRK)
Prospektywne badanie nieinterwencyjne u pacjentów z rakiem fuzyjnym TRK miejscowo zaawansowanym lub z przerzutami leczonych larotrektynibem
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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Many Locations, Argentyna
- Many Locations
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Many Locations, Austria
- Many Locations
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Many Locations, Belgia
- Many Locations
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Many Locations, Chiny
- Many Locations
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Many Locations, Finlandia
- Many Locations
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Many Locations, Francja
- Many Locations
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Many Locations, Hiszpania
- Many Locations
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Many Locations, Kanada
- Many Locations
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Many Locations, Korea Południowa
- Many Locations
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Many Locations, Luksemburg
- Many Locations
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Many Locations, Niemcy
- Many Locations
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California
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Los Angeles, California, Stany Zjednoczone, 90095
- UCLA - Mattel Children's Hospital
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Los Angeles, California, Stany Zjednoczone, 90027
- California Research Inst.
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Newport Beach, California, Stany Zjednoczone, 82663
- Hoag Memorial Hospital Presbyterian
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Palo Alto, California, Stany Zjednoczone, 94304
- Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
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Santa Monica, California, Stany Zjednoczone, 90404
- Providence Health System - Southern California
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Torrance, California, Stany Zjednoczone, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06520
- Yale University
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Florida
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Miami, Florida, Stany Zjednoczone, 33155
- Nicklaus Children's Hospital
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Miami, Florida, Stany Zjednoczone, 33146
- University of Miami
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Indiana
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Fort Wayne, Indiana, Stany Zjednoczone, 46804
- Fort Wayne Medical Oncology Hematology
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Kansas
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Wichita, Kansas, Stany Zjednoczone, 67214
- Cancer Center of Kansas
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Maine
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South Portland, Maine, Stany Zjednoczone, 04106
- Maine Health
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21205
- Johns Hopkins / Sidney Kimmel Cancer Center
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Frederick, Maryland, Stany Zjednoczone, 21702
- Frederick Health-James M Stockman Cancer Institute
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02111
- Tufts / Neely Cancer Center
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Michigan
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Farmington Hills, Michigan, Stany Zjednoczone, 48334
- Detroit Clinical Research Center
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Lansing, Michigan, Stany Zjednoczone, 48912
- Sparrow Cancer Center
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Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89169
- Nevada Cancer Research Foundation
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New York
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Buffalo, New York, Stany Zjednoczone, 14210
- Great Lakes Cancer Center
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New York, New York, Stany Zjednoczone, 10065
- Memorial Sloan Kettering Children's Cancer Center
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North Carolina
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Greenville, North Carolina, Stany Zjednoczone, 27834
- East Carolina University / Vidant Health
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Ohio
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Youngstown, Ohio, Stany Zjednoczone, 44501
- Mercy Health Youngstown
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15212
- Allegheny Health Network
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South Carolina
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Charleston, South Carolina, Stany Zjednoczone, 29425
- Medical Univ. of South Carolina
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Stany Zjednoczone, 75390
- UT Southwestern Medical Center / Children's Health
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Houston, Texas, Stany Zjednoczone, 77030
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84112
- Univ. of Utah / Huntsman Cancer Center
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Washington
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Seattle, Washington, Stany Zjednoczone, 98105
- Seattle Children's
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West Virginia
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Morgantown, West Virginia, Stany Zjednoczone, 26506
- West Virginia University
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Wisconsin
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La Crosse, Wisconsin, Stany Zjednoczone, 54601
- Gundersen Health System
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Madison, Wisconsin, Stany Zjednoczone, 53717
- SSM Health Cancer Center - Dean Medical Group
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Many Locations, Szwajcaria
- Many Locations
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Many Locations, Szwecja
- Many Locations
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Many Locations, Włochy
- Many Locations
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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GI
adult patients with gastrointestinal (GI) cancer |
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 |
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H&N
adult patients with head and neck (H&N) cancer |
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 |
|
STS
adult patients with soft tissue sarcoma (STS) |
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 |
|
CNS
adult patients with primary central nervous system (CNS) cancer |
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 |
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Lung
adult patients with lung cancer |
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 |
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Melanoma
adult patients with melanoma |
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 |
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Pediatric
all pediatric patients regardless of tumor type will be enrolled under this cohort |
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 |
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other
patients with other tumor types |
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 |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Liczba uczestników ze zdarzeniami niepożądanymi związanymi z leczeniem (TEAE)
Ramy czasowe: Do 30 dni po ostatniej dawce
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Do 30 dni po ostatniej dawce
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Nasilenie TEAE
Ramy czasowe: Do 30 dni po ostatniej dawce
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Do 30 dni po ostatniej dawce
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Powaga TEAE
Ramy czasowe: Do 30 dni po ostatniej dawce
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Do 30 dni po ostatniej dawce
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Przyczynowość TEAE
Ramy czasowe: Do 30 dni po ostatniej dawce
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Do 30 dni po ostatniej dawce
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Podjęte działania związane z leczeniem larotrektynibem
Ramy czasowe: Do 30 dni po ostatniej dawce
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Do 30 dni po ostatniej dawce
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Rozsądny związek przyczynowy między larotrektynibem a zdarzeniem niepożądanym
Ramy czasowe: Do 30 dni od ostatniej dawki
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Do 30 dni od ostatniej dawki
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Wskaźnik obiektywnych odpowiedzi (ORR)
Ramy czasowe: Do 8 lat
|
Do 8 lat
|
|
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Wskaźnik kontroli choroby (DCR)
Ramy czasowe: Do 8 lat
|
Do 8 lat
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|
|
Czas trwania odpowiedzi (DOR)
Ramy czasowe: Do 8 lat
|
Do 8 lat
|
|
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Czas do odpowiedzi (TTR)
Ramy czasowe: Do 8 lat
|
Do 8 lat
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|
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Przeżycie bez progresji choroby (PFS)
Ramy czasowe: Do 8 lat
|
Do 8 lat
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Całkowite przeżycie (OS)
Ramy czasowe: Do 8 lat
|
Do 8 lat
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|
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Całkowita dawka
Ramy czasowe: Do 8 lat
|
Do 8 lat
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Dawka początkowa i końcowa
Ramy czasowe: Do 8 lat
|
Do 8 lat
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|
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Modyfikacja dawki podczas leczenia
Ramy czasowe: Do 8 lat
|
Do 8 lat
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|
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Czas trwania leczenia (DOT)
Ramy czasowe: Do 8 lat
|
Do 8 lat
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|
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ORR według podgrupy pacjentów
Ramy czasowe: Do 8 lat
|
Do 8 lat
|
|
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DCR według podgrupy pacjentów
Ramy czasowe: Do 8 lat
|
Do 8 lat
|
|
|
DOR według podgrupy pacjentów
Ramy czasowe: Do 8 lat
|
Do 8 lat
|
|
|
TTR według podgrupy pacjentów
Ramy czasowe: Do 8 lat
|
Do 8 lat
|
|
|
PFS według podgrupy pacjentów
Ramy czasowe: Do 8 lat
|
Do 8 lat
|
|
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OS według podgrupy pacjentów
Ramy czasowe: Do 8 lat
|
Do 8 lat
|
|
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Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
Ramy czasowe: Up to 8 years
|
for all patients |
Up to 8 years
|
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Number of patients with abnormal developmental milestones
Ramy czasowe: Up to 8 years
|
Pediatric cohort only |
Up to 8 years
|
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Number of patients with abnormal Tanner stage
Ramy czasowe: Up to 8 years
|
Pediatric cohort only |
Up to 8 years
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 20324
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .