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

Launched by BAYER · Oct 25, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a drug called VITRAKVI (larotrectinib) for patients with TRK fusion cancer. TRK fusion cancer happens when a specific gene, called NTRK, fuses with another gene, leading to the growth of tumors. The trial is looking to understand how well patients tolerate VITRAKVI during their regular treatment, gathering information on their health and any changes in their condition over a period of 2 to 5 years.

To be eligible for the study, patients of any age—from newborns to adults—must have a solid tumor that has the NTRK gene fusion and a life expectancy of at least three months. The decision to use VITRAKVI must be made by their doctor before joining the study. Participants will have their medical information monitored as part of their standard care, and the trial is currently recruiting participants. If you or a loved one are considering this treatment, it’s important to discuss it with your healthcare provider to see if it’s a suitable option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult and pediatric (from birth to 18-year-old) patients
• • Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
• • Life expectancy of at least 3 months based on clinical judgement
• • Decision to treat with larotrectinib made by the treating physician prior to study enrollment
• • Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
• • Signed informed consent form
• • For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required
• Exclusion Criteria:
• • Any contraindications as listed in the local approved product information
• • Pregnancy
• • Participation in an investigational program with interventions outside of routine clinical practice
• • Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
• • Patients with NTRK gene amplification or NTRK point mutation