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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05192642
Enrollment
368
Registered
2022-01-14
Start date
2021-12-03
Completion date
2023-08-31
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors Harboring NTRK Fusion

Brief summary

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.

Interventions

DRUGData on other treatments

Real word data

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Overall survival (OS)Retrospective analysis from January 2013 to August 2022

Secondary

MeasureTime frame
Overall Treatment patternsRetrospective analysis from January 2013 to August 2022

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026