Using larotrectinib for advanced or recurrent solid tumors with NTRK gene fusion
Special Drug Use Investigation for Larotrectinib
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Drugs / interventions | larotrectinib |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT04945330 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are not being treated with larotrectinib or are participating in other investigational programs may not benefit from this study.
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 performed: Other studies have shown promising results with larotrectinib for TRK fusion cancers, indicating a potential for success in this observational approach.
Eligibility criteria
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 this trial is running
Multiple Locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.