Studie om meer te weten te komen over de veiligheid en effectiviteit van het geneesmiddel VITRAKVI tijdens routinematig gebruik bij patiënten met TRK Fusion-kanker die plaatselijk vergevorderd is of zich verspreidt van de plaats waar het begon naar andere plaatsen in het lichaam (ON-TRK)
Prospectieve niet-interventionele studie bij patiënten met lokaal gevorderde of gemetastaseerde TRK-fusiekanker behandeld met larotrectinib
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Many Locations, Argentinië
- Many Locations
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Many Locations, België
- Many Locations
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Many Locations, Canada
- Many Locations
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Many Locations, China
- Many Locations
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Many Locations, Duitsland
- Many Locations
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Many Locations, Finland
- Many Locations
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Many Locations, Frankrijk
- Many Locations
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Many Locations, Italië
- Many Locations
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Many Locations, Luxemburg
- Many Locations
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Many Locations, Oostenrijk
- Many Locations
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Many Locations, Spanje
- Many Locations
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California
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Los Angeles, California, Verenigde Staten, 90095
- UCLA - Mattel Children's Hospital
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Los Angeles, California, Verenigde Staten, 90027
- California Research Inst.
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Newport Beach, California, Verenigde Staten, 82663
- Hoag Memorial Hospital Presbyterian
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Palo Alto, California, Verenigde Staten, 94304
- Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
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Santa Monica, California, Verenigde Staten, 90404
- Providence Health System - Southern California
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Torrance, California, Verenigde Staten, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Connecticut
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New Haven, Connecticut, Verenigde Staten, 06520
- Yale University
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Florida
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Miami, Florida, Verenigde Staten, 33155
- Nicklaus Children's Hospital
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Miami, Florida, Verenigde Staten, 33146
- University of Miami
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Indiana
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Fort Wayne, Indiana, Verenigde Staten, 46804
- Fort Wayne Medical Oncology Hematology
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Kansas
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Wichita, Kansas, Verenigde Staten, 67214
- Cancer Center of Kansas
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Maine
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South Portland, Maine, Verenigde Staten, 04106
- Maine Health
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21205
- Johns Hopkins / Sidney Kimmel Cancer Center
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Frederick, Maryland, Verenigde Staten, 21702
- Frederick Health-James M Stockman Cancer Institute
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02111
- Tufts / Neely Cancer Center
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Michigan
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Farmington Hills, Michigan, Verenigde Staten, 48334
- Detroit Clinical Research Center
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Lansing, Michigan, Verenigde Staten, 48912
- Sparrow Cancer Center
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89169
- Nevada Cancer Research Foundation
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New York
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Buffalo, New York, Verenigde Staten, 14210
- Great Lakes Cancer Center
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New York, New York, Verenigde Staten, 10065
- Memorial Sloan Kettering Children's Cancer Center
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North Carolina
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Greenville, North Carolina, Verenigde Staten, 27834
- East Carolina University / Vidant Health
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Ohio
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Youngstown, Ohio, Verenigde Staten, 44501
- Mercy Health Youngstown
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Verenigde Staten, 15212
- Allegheny Health Network
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29425
- Medical Univ. of South Carolina
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Verenigde Staten, 75390
- UT Southwestern Medical Center / Children's Health
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Houston, Texas, Verenigde Staten, 77030
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84112
- Univ. of Utah / Huntsman Cancer Center
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Washington
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Seattle, Washington, Verenigde Staten, 98105
- Seattle Children's
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West Virginia
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Morgantown, West Virginia, Verenigde Staten, 26506
- West Virginia University
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Wisconsin
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La Crosse, Wisconsin, Verenigde Staten, 54601
- Gundersen Health System
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Madison, Wisconsin, Verenigde Staten, 53717
- SSM Health Cancer Center - Dean Medical Group
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Many Locations, Zuid -Korea
- Many Locations
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Many Locations, Zweden
- Many Locations
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Many Locations, Zwitserland
- Many Locations
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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 |
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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 |
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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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Aantal deelnemers met tijdens de behandeling optredende bijwerkingen (TEAE's)
Tijdsspanne: Tot 30 dagen na de laatste dosis
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Tot 30 dagen na de laatste dosis
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Ernst van TEAE's
Tijdsspanne: Tot 30 dagen na de laatste dosis
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Tot 30 dagen na de laatste dosis
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Ernst van TEAE's
Tijdsspanne: Tot 30 dagen na de laatste dosis
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Tot 30 dagen na de laatste dosis
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Causaliteit van TEAE's
Tijdsspanne: Tot 30 dagen na de laatste dosis
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Tot 30 dagen na de laatste dosis
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Ondernomen actie met betrekking tot de behandeling met larotrectinib
Tijdsspanne: Tot 30 dagen na de laatste dosis
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Tot 30 dagen na de laatste dosis
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Redelijk causaal verband tussen larotrectinib en een bijwerking
Tijdsspanne: Tot 30 dagen na de laatste dosis
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Tot 30 dagen na de laatste dosis
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Objectief responspercentage (ORR)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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Ziektebestrijdingspercentage (DCR)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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Duur van respons (DOR)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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Tijd tot reactie (TTR)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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Progressievrije overleving (PFS)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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Algehele overleving (OS)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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Totale dosis
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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Start- en einddosering
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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Dosisaanpassing tijdens de behandeling
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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Duur van de behandeling (DOT)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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ORR per patiëntensubgroep(en)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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DCR per patiëntensubgroep(en)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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DOR per patiëntensubgroep(en)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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TTR per patiëntensubgroep(en)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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PFS per patiëntensubgroep(en)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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OS per patiëntensubgroep(en)
Tijdsspanne: Tot 8 jaar
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Tot 8 jaar
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Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
Tijdsspanne: Up to 8 years
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for all patients |
Up to 8 years
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Number of patients with abnormal developmental milestones
Tijdsspanne: Up to 8 years
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Pediatric cohort only |
Up to 8 years
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Number of patients with abnormal Tanner stage
Tijdsspanne: Up to 8 years
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Pediatric cohort only |
Up to 8 years
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20324
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .