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
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-004701
- Jacksonville, Florida: 19-004701
NCT ID: NCT04142437
Sponsor Protocol Number: 20324 ON-TRK
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Scott Okuno, M.D. |
Closed for enrollment |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Steven Attia, D.O. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available