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

Overview

About this study

The purpose of this study is to describe, under real-world conditions, the safety and effectiveness of larotrectinib in patients with locally advanced or metastaticTRK fusion cancer for whom a decision to treat with larotrectinib has been made before enrollment.

 

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Scott Okuno, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Attia, D.O.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20486007

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