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Clinical Trial 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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

  • Solid Tumors Harboring NTRK Fusion

NCT number NCT05192642
Study type Observational
Source Bayer
Status Active, not recruiting
Start date December 3, 2021
Completion date February 10, 2023

See also
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Completed NCT04771390 - Study to Compare How the Body Absorbs, Distributes and Excretes the Drug Selitrectinib (BAY2731954) Given as Two Different Tablet Formulations or as Liquid Formulations Including the Effect of Food on the Absorption, Distribution or Excretion of the Different Formulations in Healthy Participants Phase 1
Recruiting NCT02637687 - A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children Phase 1/Phase 2
No longer available NCT03206931 - Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion