account_circleRecruiting

locally advanced or metastatic solid tumor harboring an NTRK gene fusion

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
150
Trial Dates
April 2020 - March 2030
Phase
Phase 4
Could I Receive a placebo
No
Products
Vitrakvi (Larotrectinib, BAY2757556)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many LocationsMany Locations, Canada
Recruiting
MD Anderson Cancer CenterHouston, 77030, United States
Recruiting
Hoag Memorial Hospital PresbyterianNewport Beach, 82663, United States
Recruiting
UT Southwestern Medical Center / Children's HealthDallas, 75390, United States
Recruiting
UCLA - Mattel Children's HospitalLos Angeles, 90095, United States
Withdrawn
St. Jude Children's Research HospitalMemphis, 38105, United States
Withdrawn
Regional Health Hope CenterTerre Haute, 47802, United States
Withdrawn
University of Pennsylvania (Penn Med)Philadelphia, 19104, United States
Recruiting
Seattle Children'sSeattle, 98105, United States
Recruiting
Stanford Univ Med Ctr. / Lucile Packard Children's HospPalo Alto, 94304, United States
Recruiting
Johns Hopkins / Sidney Kimmel Cancer CenterBaltimore, 21205, United States
Withdrawn
USC / Norris Comprehensive Cancer CenterLos Angeles, 90089, United States
Withdrawn
Nemours Children's HospitalOrlando, 32827, United States
Withdrawn
Intermountain Healthcare - Intermountain Medical CenterMurray, 84107, United States
Withdrawn
Rutgers Cancer Institute of New JerseyNew Brunswick, 08901, United States
Withdrawn
Staten Island Univ. Hospital (Northwell Health)Staten Island, 10305, United States
Withdrawn
Banner Desert Medical CenterMesa, 85202, United States
Recruiting
University of MiamiMiami, 33146, United States
Recruiting
Yale UniversityNew Haven, 06520, United States
Recruiting
Medical Univ. of South CarolinaCharleston, 29425, United States
Recruiting
Fort Wayne Medical Oncology HematologyFort Wayne, 46804, United States
Recruiting
West Virginia UniversityMorgantown, 26506, United States
Recruiting
Maine HealthSouth Portland, 04106, United States
Withdrawn
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, 90502, United States
Recruiting
Univ. of Utah / Huntsman Cancer CenterSalt Lake City, 84112, United States
Withdrawn
Levine Cancer CenterCharlotte, 28204, United States
Withdrawn
Mayo ClinicJacksonville, 32224, United States
Withdrawn
Intermountain Healthcare - Dixie Regional Medical CenterSt. George, 84790, United States
Withdrawn
Univ. of Maryland / Greenebaum Comp. Cancer Ctr.Baltimore, 21201, United States
Withdrawn
SCL HealthGrand Junction, 81501, United States
Recruiting
California Research Inst.Los Angeles, 90027, United States
Withdrawn
Ohio State Comp. Cancer Ctr. / James Cancer HospitalColumbus, 43210, United States
Terminated
Allegheny Health NetworkPittsburgh, 15212, United States
Recruiting
East Carolina University / Vidant HealthGreenville, 27834, United States
Withdrawn
UCSF Benioff Children's Hospital OaklandOakland, 94609, United States
Withdrawn
Boston Children's / Dana FarberBoston, 02215, United States
Recruiting
Detroit Clinical Research CenterFarmington Hills, 48334, United States
Withdrawn
Atlantic Hem Onc / Morristown Medical CenterMorristown, 07960, United States
Recruiting
Gundersen Health SystemLa Crosse, 54601, United States
Recruiting
Sparrow Cancer CenterLansing, 48912, United States
Terminated (Halted Prematurely)
SSM Health Cancer Center - Dean Medical GroupMadison, 53717, United States
Recruiting
Mercy Health YoungstownYoungstown, 44501, United States
Terminated
Great Lakes Cancer CenterBuffalo, 14210, United States
Terminated
Providence Health System - Southern CaliforniaSanta Monica, 90404, United States
Recruiting
Memorial Sloan Kettering Children's Cancer CenterNew York, 10065, United States
Recruiting
Cancer Center of KansasWichita, 67214, United States
Terminated (Halted Prematurely)
Frederick Health-James M Stockman Cancer InstituteFrederick, 21702, United States
Active, not recruiting
Many LocationsMany Locations, Belgium
Active, not recruiting
Many LocationsMany Locations, Switzerland
Active, not recruiting
Many LocationsMany Locations, Sweden
Active, not recruiting
Many LocationsMany Locations, Germany
Active, not recruiting
Many LocationsMany Locations, France
Active, not recruiting
Many LocationsMany Locations, Argentina
Active, not recruiting
Many LocationsMany Locations, Austria
Not yet recruiting
Many LocationsMany Locations, Australia
Withdrawn
Many LocationsMany Locations, Brazil
Active, not recruiting
Many LocationsMany Locations, China
Withdrawn
Many LocationsMany Locations, Denmark
Active, not recruiting
Many LocationsMany Locations, Spain
Active, not recruiting
Many LocationsMany Locations, Finland
Not yet recruiting
Many LocationsMany Locations, United Kingdom
Not yet recruiting
Many LocationsMany Locations, Greece
Withdrawn
Many LocationsMany Locations, Ireland
Active, not recruiting
Many LocationsMany Locations, Italy
Withdrawn
Many LocationsMany Locations, Japan
Active, not recruiting
Many LocationsMany Locations, Korea,_republic_of
Active, not recruiting
Many LocationsMany Locations, Luxembourg
Withdrawn
Many LocationsMany Locations, Norway
Withdrawn
Many LocationsMany Locations, Russia
Withdrawn
Many LocationsMany Locations, Singapore
Not yet recruiting
Many LocationsMany Locations, Taiwan
Recruiting
Vanderbilt University Medical CenterNashville, 37232, United States
Recruiting
Nevada Cancer Research FoundationLas Vegas, 89169, United States
Recruiting
Tufts / Neely Cancer CenterBoston, 02111, United States
Recruiting
Children’s Hospital of PhiladelphiaPhiladelphia, 19104, United States
Recruiting
Nicklaus Children's HospitalMiami, 33155, United States

Primary Outcome

  • Number of participants with treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 30 days after last dose
  • Severity of TEAEs
    date_rangeTime Frame:
    Up to 30 days after last dose
  • Seriousness of TEAEs
    date_rangeTime Frame:
    Up to 30 days after last dose
  • Reasonable causal relationship between larotrectinib and an AE
    date_rangeTime Frame:
    Up to 30 days after last dose
  • Causality of TEAEs
    date_rangeTime Frame:
    Up to 30 days after last dose
  • Action taken related to larotrectinib treatment
    date_rangeTime Frame:
    Up to 30 days after last dose

Secondary Outcome

  • Objective response rate (ORR)
    date_rangeTime Frame:
    Up to 8 years
  • Disease control rate (DCR)
    date_rangeTime Frame:
    Up to 8 years
  • Duration of response (DOR)
    date_rangeTime Frame:
    Up to 8 years
  • Time to response (TTR)
    date_rangeTime Frame:
    Up to 8 years
  • Progression-free survival (PFS)
    date_rangeTime Frame:
    Up to 8 years
  • Overall survival (OS)
    date_rangeTime Frame:
    Up to 8 years
  • Total dose
    date_rangeTime Frame:
    Up to 8 years
  • Starting and ending dose
    date_rangeTime Frame:
    Up to 8 years
  • Dose modification during treatment
    date_rangeTime Frame:
    Up to 8 years
  • Duration of treatment (DOT)
    date_rangeTime Frame:
    Up to 8 years
  • ORR by patient subgroup(s)
    date_rangeTime Frame:
    Up to 8 years
  • DCR by patient subgroup(s)
    date_rangeTime Frame:
    Up to 8 years
  • DOR by patient subgroup(s)
    date_rangeTime Frame:
    Up to 8 years
  • TTR by patient subgroup(s)
    date_rangeTime Frame:
    Up to 8 years
  • PFS by patient subgroup(s)
    date_rangeTime Frame:
    Up to 8 years
  • OS by patient subgroup(s)
    date_rangeTime Frame:
    Up to 8 years
  • Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
    for all patients
    date_rangeTime Frame:
    Up to 8 years
  • Number of patients with abnormal developmental milestones
    Pediatric cohort only
    date_rangeTime Frame:
    Up to 8 years
  • Number of patients with abnormal Tanner stage
    Pediatric cohort only
    date_rangeTime Frame:
    Up to 8 years

Trial design

PrOspective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A