Studie för att lära dig mer om säkerheten och effektiviteten av läkemedlet VITRAKVI under rutinmässig användning hos patienter med TRK Fusion Cancer som är lokalt avancerad eller sprids från den plats där den började till andra platser i kroppen (ON-TRK)
Prospektiv icke-interventionsstudie hos patienter med lokalt avancerad eller metastaserad TRK-fusionscancer som behandlats med 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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Many Locations, Argentina
- Many Locations
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Many Locations, Belgien
- Many Locations
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Many Locations, Finland
- Many Locations
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Many Locations, Frankrike
- Many Locations
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California
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Los Angeles, California, Förenta staterna, 90095
- UCLA - Mattel Children's Hospital
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Los Angeles, California, Förenta staterna, 90027
- California Research Inst.
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Newport Beach, California, Förenta staterna, 82663
- Hoag Memorial Hospital Presbyterian
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Palo Alto, California, Förenta staterna, 94304
- Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
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Santa Monica, California, Förenta staterna, 90404
- Providence Health System - Southern California
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Torrance, California, Förenta staterna, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06520
- Yale University
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Florida
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Miami, Florida, Förenta staterna, 33155
- Nicklaus Children's Hospital
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Miami, Florida, Förenta staterna, 33146
- University of Miami
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Indiana
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Fort Wayne, Indiana, Förenta staterna, 46804
- Fort Wayne Medical Oncology Hematology
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Kansas
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas
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Maine
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South Portland, Maine, Förenta staterna, 04106
- Maine Health
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Maryland
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Baltimore, Maryland, Förenta staterna, 21205
- Johns Hopkins / Sidney Kimmel Cancer Center
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Frederick, Maryland, Förenta staterna, 21702
- Frederick Health-James M Stockman Cancer Institute
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02111
- Tufts / Neely Cancer Center
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Michigan
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Farmington Hills, Michigan, Förenta staterna, 48334
- Detroit Clinical Research Center
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Lansing, Michigan, Förenta staterna, 48912
- Sparrow Cancer Center
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89169
- Nevada Cancer Research Foundation
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New York
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Buffalo, New York, Förenta staterna, 14210
- Great Lakes Cancer Center
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New York, New York, Förenta staterna, 10065
- Memorial Sloan Kettering Children's Cancer Center
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North Carolina
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Greenville, North Carolina, Förenta staterna, 27834
- East Carolina University / Vidant Health
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Ohio
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Youngstown, Ohio, Förenta staterna, 44501
- Mercy Health Youngstown
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Allegheny Health Network
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425
- Medical Univ. of South Carolina
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Förenta staterna, 75390
- UT Southwestern Medical Center / Children's Health
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Houston, Texas, Förenta staterna, 77030
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Förenta staterna, 84112
- Univ. of Utah / Huntsman Cancer Center
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Washington
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Seattle, Washington, Förenta staterna, 98105
- Seattle Children's
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West Virginia
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Morgantown, West Virginia, Förenta staterna, 26506
- West Virginia University
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Wisconsin
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La Crosse, Wisconsin, Förenta staterna, 54601
- Gundersen Health System
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Madison, Wisconsin, Förenta staterna, 53717
- SSM Health Cancer Center - Dean Medical Group
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Many Locations, Italien
- Many Locations
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Many Locations, Kanada
- Many Locations
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Many Locations, Kina
- Many Locations
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Many Locations, Luxemburg
- Many Locations
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Many Locations, Schweiz
- Many Locations
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Many Locations, Spanien
- Many Locations
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Many Locations, Sverige
- Many Locations
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Many Locations, Sydkorea
- Many Locations
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Many Locations, Tyskland
- Many Locations
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Many Locations, Österrike
- Many Locations
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Antal deltagare med behandlingsuppkomna biverkningar (TEAE)
Tidsram: Upp till 30 dagar efter sista dosen
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Upp till 30 dagar efter sista dosen
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Svårighetsgraden av TEAE
Tidsram: Upp till 30 dagar efter sista dosen
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Upp till 30 dagar efter sista dosen
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Allvarligheten hos TEAE
Tidsram: Upp till 30 dagar efter sista dosen
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Upp till 30 dagar efter sista dosen
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Orsakssamband för TEAE
Tidsram: Upp till 30 dagar efter sista dosen
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Upp till 30 dagar efter sista dosen
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Åtgärder vidtagna i samband med behandling med larotrectinib
Tidsram: Upp till 30 dagar efter sista dosen
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Upp till 30 dagar efter sista dosen
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Rimligt orsakssamband mellan larotrectinib och en AE
Tidsram: Upp till 30 dagar efter sista dosen
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Upp till 30 dagar efter sista dosen
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Objektiv svarsfrekvens (ORR)
Tidsram: Upp till 8 år
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Upp till 8 år
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Sjukdomskontrollfrekvens (DCR)
Tidsram: Upp till 8 år
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Upp till 8 år
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Varaktighet av svar (DOR)
Tidsram: Upp till 8 år
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Upp till 8 år
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Tid till svar (TTR)
Tidsram: Upp till 8 år
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Upp till 8 år
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Progressionsfri överlevnad (PFS)
Tidsram: Upp till 8 år
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Upp till 8 år
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Total överlevnad (OS)
Tidsram: Upp till 8 år
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Upp till 8 år
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Total dos
Tidsram: Upp till 8 år
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Upp till 8 år
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Start- och slutdos
Tidsram: Upp till 8 år
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Upp till 8 år
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Dosändring under behandlingen
Tidsram: Upp till 8 år
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Upp till 8 år
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Behandlingens varaktighet (DOT)
Tidsram: Upp till 8 år
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Upp till 8 år
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ORR efter patientundergrupp(er)
Tidsram: Upp till 8 år
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Upp till 8 år
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DCR efter patientundergrupp(er)
Tidsram: Upp till 8 år
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Upp till 8 år
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DOR efter patientundergrupp(er)
Tidsram: Upp till 8 år
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Upp till 8 år
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TTR efter patientundergrupp(er)
Tidsram: Upp till 8 år
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Upp till 8 år
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PFS efter patientundergrupp(er)
Tidsram: Upp till 8 år
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Upp till 8 år
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OS efter patientundergrupp(er)
Tidsram: Upp till 8 år
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Upp till 8 år
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Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
Tidsram: 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
Tidsram: 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
Tidsram: Up to 8 years
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Pediatric cohort only |
Up to 8 years
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20324
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
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