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

Plain-language summary

This study aims to gather information about the safety and effectiveness of the drug larotrectinib (Vitrakvi) during routine use in patients with locally advanced or spread TRK fusion cancer that carries an NTRK gene fusion. It is enrolling adult and pediatric patients (from birth to age 18) whose tumors have an NTRK gene fusion. The study is a non-phased study and is still recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Bayer

Intervention

larotrectinib(Vitrakvi, BAY2757556)

Start date

4/3/2020

Estimated completion

3/31/2030

Countries

United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Luxembourg, Norway, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Related genes

Locations

• Mesa, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Newport Beach, United States
• Oakland, United States
• Palo Alto, United States
• Santa Monica, United States
• Torrance, United States
• Grand Junction, United States
• New Haven, United States
• Jacksonville, United States
• Miami, United States
• Miami, United States
• Orlando, United States
• Fort Wayne, United States
• Terre Haute, United States
• Wichita, United States
• South Portland, United States
• Baltimore, United States
• Baltimore, United States
• Frederick, United States
• Boston, United States
• Boston, United States
• Farmington Hills, United States
• Lansing, United States
• Las Vegas, United States
• Morristown, United States
• New Brunswick, United States
• Buffalo, United States
• New York, United States
• Staten Island, United States
• Charlotte, United States
• Greenville, United States
• Columbus, United States
• Youngstown, United States
• Philadelphia, United States
• Philadelphia, United States
• Pittsburgh, United States
• Charleston, United States

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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