Advanced or Recurrent Solid Tumor Harboring an NTRK Gene FusionNCT04945330
NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes
An observational study of Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion, run by Bayer at 1 site in Japan.
Trial summary
Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer. In people with TRK fusion cancer, a gene called neurotrophic TRK, (NTRK) joins or "fuses" with another gene. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion
- What is being tested?
- Larotrectinib (Vitrakvi, BAY2757556)
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 5 Nov 2021to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric (from birth to 18 year old) patients treated with larotrectinib.
Who may be able to join
- Patients who are treated with larotrectinib or decided to be treated with larotrectinib, under routine clinical practice.
Who cannot join
- Participation in an investigational program with interventions outside of routine clinical practice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Special Drug Use Investigation for Larotrectinib
Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer.
In people with TRK fusion cancer, a gene called neurotrophic TRK, (NTRK) joins or "fuses" with another gene. This creates a protein known as a fusion protein, which can cause cancer cells to grow. The study treatment, larotrectinib, is already available for doctors to prescribe to patients with TRK fusion cancer. Larotrectinib works by blocking TRK genes in cancer cells which helps stop the cancer from growing.
Read more
In this study, the researchers want to learn more about the safety and effectiveness of larotrectinib in adults and children with advanced or recurrent TRK fusion cancer. This means that their cancer has spread from where it started to other areas of the body, or the cancer has come back after a period of time. To answer this question, the researchers will collect information from patients who are taking larotrectinib as prescribed by their doctors. The researchers will learn what adverse events the patients are having. An adverse event is any medical problem that a patient has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
The study will include patients of all ages with TRK fusion cancer.
In this study, there will be no required tests or visits to a study site. Instead, the researchers will collect information from:
- the patients' medical records
- interviews with the patients or their parents or guardians
- the patients' visits to their doctor as part of their usual care The researchers will collect information about the adults for up to about 2 years and about the children for up to about 8 years.
- Being tested
- Larotrectinib (Vitrakvi, BAY2757556)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Larotrectinib (Vitrakvi, BAY2757556)Drug
Follow clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Gastrointestinal (GI) | Participants with GI cancer. Receives: Drug: Larotrectinib (Vitrakvi, BAY2757556) | |
| Head and neck (H&N) | Participants with H\&N cancer. Receives: Drug: Larotrectinib (Vitrakvi, BAY2757556) | |
| Lung | Participants with lung cancer. Receives: Drug: Larotrectinib (Vitrakvi, BAY2757556) | |
| Soft tissue sarcoma (STS) | Participants with STS cancer. Receives: Drug: Larotrectinib (Vitrakvi, BAY2757556) | |
| Primary central nervous system (CNS) | Participants with CNS cancer. Receives: Drug: Larotrectinib (Vitrakvi, BAY2757556) | |
| Melanoma | Participants with Melanoma cancer. Receives: Drug: Larotrectinib (Vitrakvi, BAY2757556) | |
| Pediatrics | Not described Receives: Drug: Larotrectinib (Vitrakvi, BAY2757556) | |
| Others | Not described Receives: Drug: Larotrectinib (Vitrakvi, BAY2757556) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of treatment emergent adverse events (TEAEs)
Measured: Approximate 8 years
Frequency of TEAEs
Measured: Approximate 8 years
Seriousness of TEAEs
Measured: Approximate 8 years
Outcome of TEAEs
Measured: Approximate 8 years
Causality assessment of TEAEs
Measured: Approximate 8 years
Secondary outcomes (15)
Overall response rate (ORR), based on investigator assessment preferably using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Response Assessment in Neuro-Oncology (RANO) as appropriate by local investigator assessment
Measured: Approximate 8 years
Disease control rate (DCR)
Measured: Approximate 8 years
Duration of response (DOR)
Measured: Approximate 8 years
Time to response (TTR)
Measured: Approximate 8 years
Progression-free survival (PFS)
Measured: Approximate 8 years
Overall survival (OS)
Measured: Approximate 8 years
Total dose
Measured: Approximate 8 years
Starting and ending dose
Measured: Approximate 8 years
Dose modification during treatment
Measured: Approximate 8 years
Duration of treatment (DOT)
Measured: Approximate 8 years
Baseline characteristics
Including but not limited to: age, NTRK gene, NTRK gene partner, prior therapy (type, number of lines of therapy), other.
Measured: Approximate 8 years
Neurological examination (normal/abnormal)
Measured: Approximate 8 years
Change in height from baseline by visit
Measured: Approximate 8 years
Change in weight from baseline by visit
Measured: Approximate 8 years
Developmental milestones abnormalities (normal/abnormal)
Measured: Approximate 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start5 Nov 2021
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Recurrent Solid Tumor Harboring an NTRK Gene FusionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945330
- Sponsor's protocol ID
- 21793
- Status last verified
- Jul 2026
- First submitted
- 20 Jun 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for Larotrectinib
- ClinicalTrials.gov ID
- NCT04945330
- Acronym / sponsor ID
- 21793
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer.
In people with TRK fusion cancer, a gene called neurotrophic TRK, (NTRK) joins or "fuses" with another gene. This creates a protein known as a fusion protein, which can cause cancer cells to grow. The study treatment, larotrectinib, is already available for doctors to prescribe to patients with TRK fusion cancer. Larotrectinib works by blocking TRK genes in cancer cells which helps stop the cancer from growing.
In this study, the researchers want to learn more about the safety and effectiveness of larotrectinib in adults and children with advanced or recurrent TRK fusion cancer. This means that their cancer has spread from where it started to other areas of the body, or the cancer has come back after a period of time. To answer this question, the researchers will collect information from patients who are taking larotrectinib as prescribed by their doctors. The researchers will learn what adverse events the patients are having. An adverse event is any medical problem that a patient has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
The study will include patients of all ages with TRK fusion cancer.
In this study, there will be no required tests or visits to a study site. Instead, the researchers will collect information from:
- the patients' medical records
- interviews with the patients or their parents or guardians
- the patients' visits to their doctor as part of their usual care The researchers will collect information about the adults for up to about 2 years and about the children for up to about 8 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Gastrointestinal (GI) | – | Drug: Larotrectinib (Vitrakvi, BAY2757556)Participants with GI cancer. |
| Head and neck (H&N) | – | Drug: Larotrectinib (Vitrakvi, BAY2757556)Participants with H\&N cancer. |
| Lung | – | Drug: Larotrectinib (Vitrakvi, BAY2757556)Participants with lung cancer. |
| Soft tissue sarcoma (STS) | – | Drug: Larotrectinib (Vitrakvi, BAY2757556)Participants with STS cancer. |
| Primary central nervous system (CNS) | – | Drug: Larotrectinib (Vitrakvi, BAY2757556)Participants with CNS cancer. |
| Melanoma | – | Drug: Larotrectinib (Vitrakvi, BAY2757556)Participants with Melanoma cancer. |
| Pediatrics | – | Drug: Larotrectinib (Vitrakvi, BAY2757556) |
| Others | – | Drug: Larotrectinib (Vitrakvi, BAY2757556) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric (from birth to 18 year old) patients treated with larotrectinib.
Key inclusion criteria (1 listed)
- Patients who are treated with larotrectinib or decided to be treated with larotrectinib, under routine clinical practice.
Key exclusion criteria (1 listed)
- Participation in an investigational program with interventions outside of routine clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Larotrectinib (Vitrakvi, BAY2757556)Follow clinical practice | Drug | Gastrointestinal (GI), Head and neck (H&N), Lung, Melanoma, Others, Pediatrics, Primary central nervous system (CNS), Soft tissue sarcoma (STS) |
Primary outcome
Severity of treatment emergent adverse events (TEAEs)
Time frame: Approximate 8 years
Frequency of TEAEs
Time frame: Approximate 8 years
Seriousness of TEAEs
Time frame: Approximate 8 years
Outcome of TEAEs
Time frame: Approximate 8 years
Causality assessment of TEAEs
Time frame: Approximate 8 years
15 secondary outcomes
Overall response rate (ORR), based on investigator assessment preferably using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Response Assessment in Neuro-Oncology (RANO) as appropriate by local investigator assessment
Time frame: Approximate 8 years
Disease control rate (DCR)
Time frame: Approximate 8 years
Duration of response (DOR)
Time frame: Approximate 8 years
Time to response (TTR)
Time frame: Approximate 8 years
Progression-free survival (PFS)
Time frame: Approximate 8 years
Overall survival (OS)
Time frame: Approximate 8 years
Total dose
Time frame: Approximate 8 years
Starting and ending dose
Time frame: Approximate 8 years
Dose modification during treatment
Time frame: Approximate 8 years
Duration of treatment (DOT)
Time frame: Approximate 8 years
Baseline characteristics
Time frame: Approximate 8 years
Neurological examination (normal/abnormal)
Time frame: Approximate 8 years
Change in height from baseline by visit
Time frame: Approximate 8 years
Change in weight from baseline by visit
Time frame: Approximate 8 years
Developmental milestones abnormalities (normal/abnormal)
Time frame: Approximate 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of treatment emergent adverse events (TEAEs) (time frame: Approximate 8 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.