An observational study in Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion, sponsored by Bayer. Active, not recruiting at 47 sites in 15 countries. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Bayer · Observational
Australia, Brazil, Denmark, Greece, Ireland, Japan, Norway, Russia, Singapore, Taiwan, United Kingdom
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.
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult and pediatric (from birth to 18-year-old) patients with a locally advanced or metastatic solid tumor harboring an NTRK gene fusion (detected by NGS (Next-Generation Sequencing), FISH (Fluorescent In Situ Hybridization), rt-PCR (Reverse Transcription Polymerase Chain Reaction) or other genomic testing able to detect NTRK gene fusion) assessed locally for whom a decision to treat with larotrectinib has been made before enrollment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
adult patients with gastrointestinal (GI) cancer
Drug: larotrectinib(Vitrakvi, BAY2757556)
adult patients with head and neck (H\&N) cancer
Drug: larotrectinib(Vitrakvi, BAY2757556)
adult patients with soft tissue sarcoma (STS)
Drug: larotrectinib(Vitrakvi, BAY2757556)
adult patients with primary central nervous system (CNS) cancer
Drug: larotrectinib(Vitrakvi, BAY2757556)
adult patients with lung cancer
Drug: larotrectinib(Vitrakvi, BAY2757556)
adult patients with melanoma
Drug: larotrectinib(Vitrakvi, BAY2757556)
all pediatric patients regardless of tumor type will be enrolled under this cohort
Drug: larotrectinib(Vitrakvi, BAY2757556)
patients with other tumor types
Drug: 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
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 30 days after last dose
Severity of TEAEs
Time frame: Up to 30 days after last dose
Seriousness of TEAEs
Time frame: Up to 30 days after last dose
Reasonable causal relationship between larotrectinib and an AE
Time frame: Up to 30 days after last dose
Causality of TEAEs
Time frame: Up to 30 days after last dose
Action taken related to larotrectinib treatment
Time frame: Up to 30 days after last dose
Objective response rate (ORR)
Time frame: Up to 8 years
Disease control rate (DCR)
Time frame: Up to 8 years
Duration of response (DOR)
Time frame: Up to 8 years
Time to response (TTR)
Time frame: Up to 8 years
Progression-free survival (PFS)
Time frame: Up to 8 years
Overall survival (OS)
Time frame: Up to 8 years
Total dose
Time frame: Up to 8 years
Starting and ending dose
Time frame: Up to 8 years
Dose modification during treatment
Time frame: Up to 8 years
Duration of treatment (DOT)
Time frame: Up to 8 years
ORR by patient subgroup(s)
Time frame: Up to 8 years
DCR by patient subgroup(s)
Time frame: Up to 8 years
DOR by patient subgroup(s)
Time frame: Up to 8 years
TTR by patient subgroup(s)
Time frame: Up to 8 years
PFS by patient subgroup(s)
Time frame: Up to 8 years
OS by patient subgroup(s)
Time 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
Time frame: Up to 8 years
Number of patients with abnormal developmental milestones
Pediatric cohort only
Time frame: Up to 8 years
Number of patients with abnormal Tanner stage
Pediatric cohort only
Time frame: Up to 8 years
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Australia, Brazil, Denmark, Greece, Ireland, Japan, Norway, Russia, Singapore, Taiwan, United Kingdom
Australia, Brazil, Denmark, Greece, Ireland, Japan, Norway, Russia, Singapore, Taiwan, United Kingdom
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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