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 (NCT04142437)
PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
🩺 Plain-English Summary (8th-Grade Level)
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated 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. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (6 items).
Location: Banner Desert Medical Center — Mesa, Arizona
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (76 Sites)
Showing the first 25 of 76 sites.
- Banner Desert Medical Center — Mesa, Arizona
- California Research Inst. — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- UCLA - Mattel Children's Hospital — Los Angeles, California
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- UCSF Benioff Children's Hospital Oakland — Oakland, California
- Stanford Univ Med Ctr. / Lucile Packard Children's Hosp — Palo Alto, California
- Providence Health System - Southern California — Santa Monica, California
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California
- SCL Health — Grand Junction, Colorado
- Yale University — New Haven, Connecticut
- Mayo Clinic — Jacksonville, Florida
- University of Miami — Miami, Florida
- Nicklaus Children's Hospital — Miami, Florida
- Nemours Children's Hospital — Orlando, Florida
- Fort Wayne Medical Oncology Hematology — Fort Wayne, Indiana
- Regional Health Hope Center — Terre Haute, Indiana
- Cancer Center of Kansas — Wichita, Kansas
- Maine Health — South Portland, Maine
- Univ. of Maryland / Greenebaum Comp. Cancer Ctr. — Baltimore, Maryland
- Johns Hopkins / Sidney Kimmel Cancer Center — Baltimore, Maryland
- Frederick Health-James M Stockman Cancer Institute — Frederick, Maryland
- Tufts / Neely Cancer Center — Boston, Massachusetts
- Boston Children's / Dana Farber — Boston, Massachusetts
- Detroit Clinical Research Center — Farmington Hills, Michigan
📞 Contact the Study Coordinator
Phone: (888) 842-2937
Email: clinical-trials-contact@bayer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.