Using larotrectinib for advanced or recurrent solid tumors with NTRK gene fusion
Official title: Special Drug Use Investigation for Larotrectinib
Run by Bayer · NCT04945330 · Data updated 2026-11-12
This study is testing how well larotrectinib works for adults and children with advanced or recurrent solid tumors caused by NTRK gene fusions.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Bayer Industry-sponsored |
| Drugs / interventions | larotrectinib |
| Locations | 1 site (Multiple Locations) |
| Status | Recruiting |
| Started | November 5, 2021 |
| Main results expected | June 30, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT04945330 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with advanced or recurrent solid tumors that harbor an NTRK gene fusion and are being treated with larotrectinib.
✕Probably not a fit
Patients who are not being treated with larotrectinib or are participating in other investigational programs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to gather real-world data on the safety and effectiveness of larotrectinib, a treatment for TRK fusion cancer caused by NTRK gene fusions. Researchers will collect information from patients, both adults and children, who are receiving larotrectinib for advanced or recurrent solid tumors. The study focuses on understanding how well this medication works in clinical practice and its impact on cancer progression. By analyzing patient outcomes, the study seeks to provide insights into the management of this rare cancer type.
Why it matters
Potential benefit: If successful, this study could enhance understanding of larotrectinib's effectiveness, potentially leading to improved treatment strategies for patients with TRK fusion cancer.
How similar studies have gone: Other studies have shown promising results with larotrectinib for TRK fusion cancers, indicating a potential for success in this observational approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are treated with larotrectinib or decided to be treated with larotrectinib, under routine clinical practice. Exclusion Criteria: * Participation in an investigational program with interventions outside of routine clinical practice
Where it's running
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Many locations
Multiple Locations, Japan Recruiting
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using Larotrectinib to Improve Radioactive Iodine Treatment in Thyroid Cancer
This study is testing if adding a drug called larotrectinib to radioactive iodine treatment can help people with a specific type of thyroid cancer that has spread to the lungs feel better.
-
Treatment of advanced solid tumors with larotrectinib for NTRK gene amplification
This study is testing if a new drug called larotrectinib can help people with advanced solid tumors that have a specific gene change called NTRK amplification.
-
Using Larotrectinib for Children with Newly Diagnosed High-Grade Glioma with NTRK Fusion
This study is testing if a new drug called larotrectinib can help children with a specific type of brain cancer called high-grade glioma that has an NTRK fusion.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.