Actively Recruiting
Observational Study of Larotrectinib VITRAKVI Safety and Effectiveness in Patients With Locally Advanced or Metastatic TRK Fusion Solid Tumors
Led by Bayer · Updated on 2026-07-07
150
Participants Needed
76
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating how well the drug VITRAKVI generic name larotrectinib works and how well patients tolerate it in real-world use for those with TRK fusion cancer. This cancer type involves a genetic change called an NTRK gene fusion that can cause tumors to grow. The study includes adults and children with locally advanced or metastatic solid tumors that have this specific gene fusion, reflecting a variety of common and rare cancers. Patients enrolled in this observational study are those for whom their doctors have decided to treat with larotrectinib. Treatments and medical care follow local standard practices without interference from the study. Participants are grouped based on cancer types like gastrointestinal, head and neck, soft tissue sarcoma, CNS, lung, melanoma, pediatric tumors, and others. Data on treatments, other medications, disease changes, and health symptoms will be collected during routine care. Participants will be observed for 24 to 60 months. Researchers will collect information on treatment side effects up to 30 days after treatment ends and monitor responses, disease control, survival, doses, and developmental milestones for up to 8 years. Medical records, including height, weight, neurological assessments, and Tanner stage will be reviewed as part of this long-term observation.
CONDITIONS
Brief Title
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
Research Team
B
Bayer Clinical Trials Contact
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