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

Recruiting now

Conditions studied: Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

In brief

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.

Key facts

Study ID

NCT04142437

Run by

Bayer

People needed

150

Starts

2020-04-03

Expected to finish

2030-03-31

Last updated by the study team

2026-07-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Univ. of Utah / Huntsman Cancer Center — Salt Lake City, Utah, United States (enrolling)
• Nevada Cancer Research Foundation — Las Vegas, Nevada, United States (enrolling)
• Mercy Health Youngstown — Youngstown, Ohio, United States (enrolling)
• UT Southwestern Medical Center / Children's Health — Dallas, Texas, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Sparrow Cancer Center — Lansing, Michigan, United States (enrolling)
• California Research Inst. — Los Angeles, California, United States (enrolling)
• Memorial Sloan Kettering Children's Cancer Center — New York, New York, United States (enrolling)
• East Carolina University / Vidant Health — Greenville, North Carolina, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Nicklaus Children's Hospital — Miami, Florida, United States (enrolling)
• Stanford Univ Med Ctr. / Lucile Packard Children's Hosp — Palo Alto, California, United States (enrolling)
• Fort Wayne Medical Oncology Hematology — Fort Wayne, Indiana, United States (enrolling)
• UCLA - Mattel Children's Hospital — Los Angeles, California, United States (enrolling)
• Cancer Center of Kansas — Wichita, Kansas, United States (enrolling)
• Maine Health — South Portland, Maine, United States (enrolling)
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
• Johns Hopkins / Sidney Kimmel Cancer Center — Baltimore, Maryland, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Tufts / Neely Cancer Center — Boston, Massachusetts, United States (enrolling)
• Medical Univ. of South Carolina — Charleston, South Carolina, United States (enrolling)
• Detroit Clinical Research Center — Farmington Hills, Michigan, United States (enrolling)
• Seattle Children's — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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