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Completed

NCT Number: NCT05192642

A Study Called VICTORIA to Learn More About How Well Larotrectinib Works in Adults With TRK Fusion-positive Cancer by Comparing Larotrectinib Data From Clinical Studies With Data of Other Treatments From Actual Practice

This is an observational study in which patient data from the past of adult people with solid tumors harboring NTRK gene fusion are studied. This study will focus on 5 tumor types which have been at the late stage or have spread to other parts of the body. These 5 tumor types are:

* Non-small-cell-lung cancer * Colorectal cancer (located in the intestine) * Thyroid cancer * Sarcomas (located in the connective tissue like bones or body fat) * Salivary gland carcinoma

In some people with cancer, the cancer cells have specific changes in their building plans (genes) called NTRK gene fusion. NTRK stands for neurotrophic tyrosine receptor kinase, the specific gene that is changed. Due to this change in the gene, an altered protein known as a TRK fusion protein is made, which can cause cancer cells to grow and survive. While NTRK is the gene, TRK (tropomyosin receptor kinase) is the name of the protein. The specific cancer is therefore also called TRK fusion-positive cancer.

The study drug, larotrectinib works by blocking the altered TRK fusion protein. Larotrectinib is already available in the US, Europe, and in other countries and is approved for doctors to prescribe to patients with TRK fusion cancer.

The main purpose of this study is to learn more about how well larotrectinib works in adults with TRK fusion-positive cancer compared to other treatments. Researchers will compare how long participants who received larotrectninib lived to how long participants who received other treatments lived. To do this, larotrectinib data from past clinical studies will be compared with data on other treatments gathered from different health data sources. The data will cover the time between January 2013 and end of August 2022.

Besides this data collection, no further tests or examinations are planned and no visits are required in this study.

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Key information

Conditions

Solid Tumors Harboring NTRK Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayer

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of advanced stage of disease or metastatic disease.

Exclusion criteria

  • Patients involved in TRK inhibitor clinical trials will be excluded from RW control cohort.

Treatment and study plan

larotrectinib(Vitrakvi, BAY2757556)

Drug

Clinical trials

Data on other treatments

Drug

Real word data

Primary outcomes

  1. Overall survival (OS)

    Time frame: Retrospective analysis from January 2013 to August 2022

Secondary outcomes

  1. Overall Treatment patterns

    Time frame: Retrospective analysis from January 2013 to August 2022

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Comparative Effectiveness Study of Real-world Control of TRK Fusion Positive Cancer With Patients From Larotrectinib (Vitrakvi) Clinical Trials

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 14, 2022
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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