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

Conditions

• Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• larotrectinib(Vitrakvi, BAY2757556) — DRUG
  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

Study Details

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 Dates

Start date

Apr 3, 2020

Status verified

Apr 2026

Primary completion

Nov 30, 2029

Completion

Mar 31, 2030

Study Design

Enrollment

150 participants (estimated)

Arms

• Arm: GI
  adult patients with gastrointestinal (GI) cancer
• Arm: H&N
  adult patients with head and neck (H\&N) cancer
• Arm: STS
  adult patients with soft tissue sarcoma (STS)
• Arm: CNS
  adult patients with primary central nervous system (CNS) cancer
• Arm: Lung
  adult patients with lung cancer
• Arm: Melanoma
  adult patients with melanoma
• Arm: Pediatric
  all pediatric patients regardless of tumor type will be enrolled under this cohort
• Arm: other
  patients with other tumor types

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 30 days after last dose ]

Central Contacts

• Bayer Clinical Trials Contact
  (+)1-888-84 22937
  [email protected]

Locations (51)

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