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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
Sponsor: Bayer
Summary
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.
Official title: PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2020-04-03
Completion Date
2030-03-31
Last Updated
2026-03-02
Healthy Volunteers
No
Interventions
larotrectinib(Vitrakvi, BAY2757556)
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
Locations (76)
Banner Desert Medical Center
Mesa, Arizona, United States
California Research Inst.
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA - Mattel Children's Hospital
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
Palo Alto, California, United States
Providence Health System - Southern California
Santa Monica, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
SCL Health
Grand Junction, Colorado, United States
Yale University
New Haven, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Fort Wayne Medical Oncology Hematology
Fort Wayne, Indiana, United States
Regional Health Hope Center
Terre Haute, Indiana, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Maine Health
South Portland, Maine, United States
Univ. of Maryland / Greenebaum Comp. Cancer Ctr.
Baltimore, Maryland, United States
Johns Hopkins / Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Frederick Health-James M Stockman Cancer Institute
Frederick, Maryland, United States
Tufts / Neely Cancer Center
Boston, Massachusetts, United States
Boston Children's / Dana Farber
Boston, Massachusetts, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, United States
Sparrow Cancer Center
Lansing, Michigan, United States
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Atlantic Hem Onc / Morristown Medical Center
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Great Lakes Cancer Center
Buffalo, New York, United States
Memorial Sloan Kettering Children's Cancer Center
New York, New York, United States
Staten Island Univ. Hospital (Northwell Health)
Staten Island, New York, United States
Levine Cancer Center
Charlotte, North Carolina, United States
East Carolina University / Vidant Health
Greenville, North Carolina, United States
Ohio State Comp. Cancer Ctr. / James Cancer Hospital
Columbus, Ohio, United States
Mercy Health Youngstown
Youngstown, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania (Penn Med)
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Medical Univ. of South Carolina
Charleston, South Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center / Children's Health
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Intermountain Healthcare - Intermountain Medical Center
Murray, Utah, United States
Univ. of Utah / Huntsman Cancer Center
Salt Lake City, Utah, United States
Intermountain Healthcare - Dixie Regional Medical Center
St. George, Utah, United States
Seattle Children's
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Gundersen Health System
La Crosse, Wisconsin, United States
SSM Health Cancer Center - Dean Medical Group
Madison, Wisconsin, United States
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