Studio per saperne di più sulla sicurezza e l'efficacia del farmaco VITRAKVI durante l'uso di routine in pazienti con carcinoma della fusione TRK che è localmente avanzato o diffuso dal punto in cui è iniziato ad altre parti del corpo (ON-TRK)
Studio prospettico non interventistico in pazienti con carcinoma della fusione TRK localmente avanzato o metastatico trattati con 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Many Locations, Argentina
- Many Locations
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Many Locations, Austria
- Many Locations
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Many Locations, Belgio
- Many Locations
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Many Locations, Canada
- Many Locations
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Many Locations, Cina
- Many Locations
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Many Locations, Corea del Sud
- Many Locations
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Many Locations, Finlandia
- Many Locations
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Many Locations, Francia
- Many Locations
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Many Locations, Germania
- Many Locations
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Many Locations, Italia
- Many Locations
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Many Locations, Lussemburgo
- Many Locations
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Many Locations, Spagna
- Many Locations
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California
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Los Angeles, California, Stati Uniti, 90095
- UCLA - Mattel Children's Hospital
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Los Angeles, California, Stati Uniti, 90027
- California Research Inst.
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Newport Beach, California, Stati Uniti, 82663
- Hoag Memorial Hospital Presbyterian
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Palo Alto, California, Stati Uniti, 94304
- Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
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Santa Monica, California, Stati Uniti, 90404
- Providence Health System - Southern California
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Torrance, California, Stati Uniti, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06520
- Yale University
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Florida
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Miami, Florida, Stati Uniti, 33155
- Nicklaus Children's Hospital
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Miami, Florida, Stati Uniti, 33146
- University of Miami
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Indiana
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Fort Wayne, Indiana, Stati Uniti, 46804
- Fort Wayne Medical Oncology Hematology
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Kansas
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Wichita, Kansas, Stati Uniti, 67214
- Cancer Center of Kansas
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Maine
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South Portland, Maine, Stati Uniti, 04106
- Maine Health
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Maryland
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Baltimore, Maryland, Stati Uniti, 21205
- Johns Hopkins / Sidney Kimmel Cancer Center
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Frederick, Maryland, Stati Uniti, 21702
- Frederick Health-James M Stockman Cancer Institute
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02111
- Tufts / Neely Cancer Center
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Michigan
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Farmington Hills, Michigan, Stati Uniti, 48334
- Detroit Clinical Research Center
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Lansing, Michigan, Stati Uniti, 48912
- Sparrow Cancer Center
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89169
- Nevada Cancer Research Foundation
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New York
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Buffalo, New York, Stati Uniti, 14210
- Great Lakes Cancer Center
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New York, New York, Stati Uniti, 10065
- Memorial Sloan Kettering Children's Cancer Center
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North Carolina
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Greenville, North Carolina, Stati Uniti, 27834
- East Carolina University / Vidant Health
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Ohio
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Youngstown, Ohio, Stati Uniti, 44501
- Mercy Health Youngstown
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Stati Uniti, 15212
- Allegheny Health Network
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425
- Medical Univ. of South Carolina
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Stati Uniti, 75390
- UT Southwestern Medical Center / Children's Health
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Houston, Texas, Stati Uniti, 77030
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Stati Uniti, 84112
- Univ. of Utah / Huntsman Cancer Center
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Washington
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Seattle, Washington, Stati Uniti, 98105
- Seattle Children's
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West Virginia
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Morgantown, West Virginia, Stati Uniti, 26506
- West Virginia University
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Wisconsin
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La Crosse, Wisconsin, Stati Uniti, 54601
- Gundersen Health System
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Madison, Wisconsin, Stati Uniti, 53717
- SSM Health Cancer Center - Dean Medical Group
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Many Locations, Svezia
- Many Locations
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Many Locations, Svizzera
- Many Locations
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di 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
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Numero di partecipanti con eventi avversi emergenti dal trattamento (TEAE)
Lasso di tempo: Fino a 30 giorni dopo l'ultima dose
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Fino a 30 giorni dopo l'ultima dose
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Gravità dei TEAE
Lasso di tempo: Fino a 30 giorni dopo l'ultima dose
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Fino a 30 giorni dopo l'ultima dose
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Gravità dei TEAE
Lasso di tempo: Fino a 30 giorni dopo l'ultima dose
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Fino a 30 giorni dopo l'ultima dose
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Causalità dei TEAE
Lasso di tempo: Fino a 30 giorni dopo l'ultima dose
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Fino a 30 giorni dopo l'ultima dose
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Azione intrapresa in relazione al trattamento con larotrectinib
Lasso di tempo: Fino a 30 giorni dopo l'ultima dose
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Fino a 30 giorni dopo l'ultima dose
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Ragionevole relazione causale tra larotrectinib e un evento avverso
Lasso di tempo: Fino a 30 giorni dopo l'ultima dose
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Fino a 30 giorni dopo l'ultima dose
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Tasso di risposta obiettiva (ORR)
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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Tasso di controllo della malattia (DCR)
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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Durata della risposta (DOR)
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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Tempo di risposta (TTR)
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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Sopravvivenza libera da progressione (PFS)
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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Sopravvivenza globale (OS)
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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Dose totale
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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Dose iniziale e finale
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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Modifica della dose durante il trattamento
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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Durata del trattamento (DOT)
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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ORR per sottogruppo/i di pazienti
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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DCR per sottogruppi di pazienti
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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DOR per sottogruppo/i di pazienti
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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TTR per sottogruppo/i di pazienti
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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PFS per sottogruppi di pazienti
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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OS per sottogruppo/i di pazienti
Lasso di tempo: Fino a 8 anni
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Fino a 8 anni
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Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 8 years
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Pediatric cohort only |
Up to 8 years
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 20324
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .