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NCT04142437 Clinical Trial

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

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion Clinical Trial

— ON-TRK  

Official title:
PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04142437
Other study ID # 20324
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 3, 2020
Est. completion date March 31, 2030

Study information
Verified date June 2024
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email clinical-trials-contact@bayer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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Study Design

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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
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Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-emergent adverse events (TEAEs) Up to 30 days after last dose
Primary Severity of TEAEs Up to 30 days after last dose
Primary Seriousness of TEAEs Up to 30 days after last dose
Primary Outcome of TEAEs Up to 30 days after last dose
Primary Causality of TEAEs Up to 30 days after last dose
Primary Action taken related to larotrectinib treatment Up to 30 days after last dose
Secondary Objective response rate (ORR) Up to 8 years
Secondary Disease control rate (DCR) Up to 8 years
Secondary Duration of response (DOR) Up to 8 years
Secondary Time to response (TTR) Up to 8 years
Secondary Progression-free survival (PFS) Up to 8 years
Secondary Overall survival (OS) Up to 8 years
Secondary Total dose Up to 8 years
Secondary Starting and ending dose Up to 8 years
Secondary Dose modification during treatment Up to 8 years
Secondary Duration of treatment (DOT) Up to 8 years
Secondary ORR by patient subgroup(s) Up to 8 years
Secondary DCR by patient subgroup(s) Up to 8 years
Secondary DOR by patient subgroup(s) Up to 8 years
Secondary TTR by patient subgroup(s) Up to 8 years
Secondary PFS by patient subgroup(s) Up to 8 years
Secondary OS by patient subgroup(s) Up to 8 years
Secondary Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal) for all patients Up to 8 years
Secondary Number of patients with abnormal developmental milestones Pediatric cohort only Up to 8 years
Secondary Number of patients with abnormal Tanner stage Pediatric cohort only Up to 8 years
See also
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