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Active, not recruiting No phase listed Observational

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

ClinicalTrials.gov ID: NCT04142437

Public ClinicalTrials.gov record NCT04142437. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 8:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04142437
Recruitment status
Active, not recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Bayer
Industry
Enrollment
54 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 3, 2020 (Actual)
Primary completion
Dec 31, 2029 (Estimated)
Completion
Aug 1, 2030 (Estimated)
Last update posted
Oct 22, 2026

2020 – 2030

United States locations

U.S. sites
33
U.S. states
21
U.S. cities
31
Facility City State ZIP Site status
California Research Inst. Los Angeles California 90027 —
UCLA - Mattel Children's Hospital Los Angeles California 90095 —
Hoag Memorial Hospital Presbyterian Newport Beach California 82663 —
Stanford Univ Med Ctr. / Lucile Packard Children's Hosp Palo Alto California 94304 —
Providence Health System - Southern California Santa Monica California 90404 —
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California 90502 —
Yale University New Haven Connecticut 06520 —
University of Miami Miami Florida 33146 —
Nicklaus Children's Hospital Miami Florida 33155 —
Fort Wayne Medical Oncology Hematology Fort Wayne Indiana 46804 —
Cancer Center of Kansas Wichita Kansas 67214 —
Maine Health South Portland Maine 04106 —
Johns Hopkins / Sidney Kimmel Cancer Center Baltimore Maryland 21205 —
Frederick Health-James M Stockman Cancer Institute Frederick Maryland 21702 —
Tufts / Neely Cancer Center Boston Massachusetts 02111 —
Detroit Clinical Research Center Farmington Hills Michigan 48334 —
Sparrow Cancer Center Lansing Michigan 48912 —
Nevada Cancer Research Foundation Las Vegas Nevada 89169 —
Great Lakes Cancer Center Buffalo New York 14210 —
Memorial Sloan Kettering Children's Cancer Center New York New York 10065 —
East Carolina University / Vidant Health Greenville North Carolina 27834 —
Mercy Health Youngstown Youngstown Ohio 44501 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Allegheny Health Network Pittsburgh Pennsylvania 15212 —
Medical Univ. of South Carolina Charleston South Carolina 29425 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
UT Southwestern Medical Center / Children's Health Dallas Texas 75390 —
MD Anderson Cancer Center Houston Texas 77030 —
Univ. of Utah / Huntsman Cancer Center Salt Lake City Utah 84112 —
Seattle Children's Seattle Washington 98105 —
West Virginia University Morgantown West Virginia 26506 —
Gundersen Health System La Crosse Wisconsin 54601 —
SSM Health Cancer Center - Dean Medical Group Madison Wisconsin 53717 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04142437, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 22, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04142437 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →