Actively Recruiting
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
Led by Bayer · Updated on 2026-04-14
150
Participants Needed
76
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult and pediatric patients from birth to 18 years old
- Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion confirmed by accepted genomic testing methods
- Life expectancy of at least 3 months as judged clinically
- Decision to treat with larotrectinib made before study enrollment
- Patients may be enrolled if larotrectinib treatment started within 2 months plus or minus 3 days before signing consent
- Signed informed consent, and for minors, signed assent plus parental or guardian consent is required
You will not qualify if you...
- Any contraindications listed in the local approved larotrectinib product information
- Pregnancy
- Participation in investigational programs with treatments outside routine clinical practice
- Prior treatment with larotrectinib or other TRK inhibitor kinase inhibitors
- Patients with NTRK gene amplification or point mutations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 76 locations
1
Banner Desert Medical Center
Mesa, Arizona, United States, 85202
Withdrawn
2
California Research Inst.
Los Angeles, California, United States, 90027
Actively Recruiting
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
Withdrawn
4
UCLA - Mattel Children's Hospital
Los Angeles, California, United States, 90095
Actively Recruiting
5
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 82663
Actively Recruiting
6
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Withdrawn
7
Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
Palo Alto, California, United States, 94304
Actively Recruiting
8
Providence Health System - Southern California
Santa Monica, California, United States, 90404
Terminated
9
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Withdrawn
10
SCL Health
Grand Junction, Colorado, United States, 81501
Withdrawn
11
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
12
Mayo Clinic
Jacksonville, Florida, United States, 32224
Withdrawn
13
University of Miami
Miami, Florida, United States, 33146
Actively Recruiting
14
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
15
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Withdrawn
16
Fort Wayne Medical Oncology Hematology
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
17
Regional Health Hope Center
Terre Haute, Indiana, United States, 47802
Withdrawn
18
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
Actively Recruiting
19
Maine Health
South Portland, Maine, United States, 04106
Actively Recruiting
20
Univ. of Maryland / Greenebaum Comp. Cancer Ctr.
Baltimore, Maryland, United States, 21201
Withdrawn
21
Johns Hopkins / Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21205
Actively Recruiting
22
Frederick Health-James M Stockman Cancer Institute
Frederick, Maryland, United States, 21702
Terminated
23
Tufts / Neely Cancer Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
24
Boston Children's / Dana Farber
Boston, Massachusetts, United States, 02215
Withdrawn
25
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
26
Sparrow Cancer Center
Lansing, Michigan, United States, 48912
Actively Recruiting
27
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89169
Actively Recruiting
28
Atlantic Hem Onc / Morristown Medical Center
Morristown, New Jersey, United States, 07960
Withdrawn
29
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Withdrawn
30
Great Lakes Cancer Center
Buffalo, New York, United States, 14210
Terminated
31
Memorial Sloan Kettering Children's Cancer Center
New York, New York, United States, 10065
Actively Recruiting
32
Staten Island Univ. Hospital (Northwell Health)
Staten Island, New York, United States, 10305
Withdrawn
33
Levine Cancer Center
Charlotte, North Carolina, United States, 28204
Withdrawn
34
East Carolina University / Vidant Health
Greenville, North Carolina, United States, 27834
Actively Recruiting
35
Ohio State Comp. Cancer Ctr. / James Cancer Hospital
Columbus, Ohio, United States, 43210
Withdrawn
36
Mercy Health Youngstown
Youngstown, Ohio, United States, 44501
Actively Recruiting
37
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
38
University of Pennsylvania (Penn Med)
Philadelphia, Pennsylvania, United States, 19104
Withdrawn
39
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Terminated
40
Medical Univ. of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
41
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Withdrawn
42
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
43
UT Southwestern Medical Center / Children's Health
Dallas, Texas, United States, 75390
Actively Recruiting
44
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
45
Intermountain Healthcare - Intermountain Medical Center
Murray, Utah, United States, 84107
Withdrawn
46
Univ. of Utah / Huntsman Cancer Center
Salt Lake City, Utah, United States, 84112
Actively Recruiting
47
Intermountain Healthcare - Dixie Regional Medical Center
St. George, Utah, United States, 84790
Withdrawn
48
Seattle Children's
Seattle, Washington, United States, 98105
Actively Recruiting
49
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
50
Gundersen Health System
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
51
SSM Health Cancer Center - Dean Medical Group
Madison, Wisconsin, United States, 53717
Terminated
52
Many Locations
Multiple Locations, Argentina
Active, Not Recruiting
53
Many Locations
Multiple Locations, Australia
Not Yet Recruiting
54
Many Locations
Multiple Locations, Austria
Active, Not Recruiting
55
Many Locations
Multiple Locations, Belgium
Active, Not Recruiting
56
Many Locations
Multiple Locations, Brazil
Withdrawn
57
Many Locations
Multiple Locations, Canada
Completed
58
Many Locations
Multiple Locations, China
Active, Not Recruiting
59
Many Locations
Multiple Locations, Denmark
Withdrawn
60
Many Locations
Multiple Locations, Finland
Active, Not Recruiting
61
Many Locations
Multiple Locations, France
Active, Not Recruiting
62
Many Locations
Multiple Locations, Germany
Active, Not Recruiting
63
Many Locations
Multiple Locations, Greece
Not Yet Recruiting
64
Many Locations
Multiple Locations, Ireland
Withdrawn
65
Many Locations
Multiple Locations, Italy
Active, Not Recruiting
66
Many Locations
Multiple Locations, Japan
Withdrawn
67
Many Locations
Multiple Locations, Luxembourg
Active, Not Recruiting
68
Many Locations
Multiple Locations, Norway
Withdrawn
69
Many Locations
Multiple Locations, Russia
Withdrawn
70
Many Locations
Multiple Locations, Singapore
Withdrawn
71
Many Locations
Multiple Locations, South Korea
Active, Not Recruiting
72
Many Locations
Multiple Locations, Spain
Active, Not Recruiting
73
Many Locations
Multiple Locations, Sweden
Active, Not Recruiting
74
Many Locations
Multiple Locations, Switzerland
Active, Not Recruiting
75
Many Locations
Multiple Locations, Taiwan
Withdrawn
76
Many Locations
Multiple Locations, United Kingdom
Not Yet Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
8
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here