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VITRAKVI

Sponsor:

Bayer

Code:

NCT04142437

Conditions

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

larotrectinib(Vitrakvi, BAY2757556)

Study Details

Brief summary:

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.

Conditions

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Study ID

NCT04142437

Start date

Apr 3, 2020

Status verified date

Oct, 2026

Completion date

Aug 1, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Interventions and Outcome Measures

Arms

GI

adult patients with gastrointestinal (GI) cancer

H&N

adult patients with head and neck (H\&N) cancer

STS

adult patients with soft tissue sarcoma (STS)

CNS

adult patients with primary central nervous system (CNS) cancer

Lung

adult patients with lung cancer

Melanoma

adult patients with melanoma

Pediatric

all pediatric patients regardless of tumor type will be enrolled under this cohort

other

patients with other tumor types

Interventions

larotrectinib(Vitrakvi, BAY2757556)

In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol

Primary outcome measure

  • Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 30 days after last dose ]
  • Severity of TEAEs [ Time Frame: Up to 30 days after last dose ]
  • Seriousness of TEAEs [ Time Frame: Up to 30 days after last dose ]
  • Reasonable causal relationship between larotrectinib and an AE [ Time Frame: Up to 30 days after last dose ]
  • Causality of TEAEs [ Time Frame: Up to 30 days after last dose ]
  • Action taken related to larotrectinib treatment [ Time Frame: Up to 30 days after last dose ]

Central Contacts and Locations

More Information

Sponsor

Bayer

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Bayer on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.