NCT04142437Active, not 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
PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 54 (actual)
- First submitted
- 17 Oct 2019
- Start date
- Apr 2020
- Primary completion date
- Dec 2029
- Lead sponsor
- Bayer
- Diseases
- Childhood cancers
- NCT number
- NCT04142437
What you commit to
- Study type: Observational
- Participants enrolled: 54
- From Apr 2020 to the primary completion date, Dec 2029
- 47 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
Other
- Any contraindications as listed in the local approved product information
- Pregnancy
- Participation in an investigational program with interventions outside of routine clinical practice
- Patients with NTRK gene amplification or NTRK point mutation
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Argentina | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Austria | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Belgium | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Canada | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Switzerland | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | China | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Germany | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Spain | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Finland | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | France | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Italy | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | South Korea | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Luxembourg | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Many Locations | Sweden | Unknown status |
| Johns Hopkins / Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Tufts / Neely Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Great Lakes Cancer Center Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Medical Univ. of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| UT Southwestern Medical Center / Children's Health Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Detroit Clinical Research Center Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Fort Wayne Medical Oncology & Hematology Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Frederick Health- James M Stockman Cancer Institute Coordinator of this site? Confirm its status | Frederick | United States | Unknown status |
| East Carolina University / Vidant Health Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Gundersen Health System Coordinator of this site? Confirm its status | La Crosse | United States | Unknown status |
| Sparrow Cancer Center Coordinator of this site? Confirm its status | Lansing | United States | Unknown status |
| Nevada Cancer Research Foundation Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| UCLA Mattel Children's Hospital Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| California Research Inst. Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| SSM Health Cancer Center - Dean Medical Group Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Nicklaus Children's Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Hoag Memorial Hospital Presbyterian Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Memorial Sloan Kettering Children's Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stanford Univ Med Ctr. / Lucile Packard Children's Hosp Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Allegheny Health Network Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Univ. of Utah / Huntsman Cancer Center Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Providence Health System - Southern California Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| Seattle Children's Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Maine Health Coordinator of this site? Confirm its status | South Portland | United States | Unknown status |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Cancer Center of Kansas Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
| Mercy Health Youngstown Coordinator of this site? Confirm its status | Youngstown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.