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NCT04945330Recruiting

NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes

Special Drug Use Investigation for Larotrectinib

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer. In people with TRK fusion cancer, a gene called neurotrophic TRK, (NTRK) joins or "fuses" with another gene. This creates a protein known as a fusion protein, which can cause cancer cells to grow. The study treatment, larotrectinib, is already available for doctors to prescribe to patients with TRK fusion cancer. Larotrectinib works by blocking TRK genes in cancer cells which helps stop the cancer from growing. In this study, the researchers want to learn more about the safety and effectiveness of larotrectinib in adults and children with advanced or recurrent TRK fusion cancer. This means that their cancer has spread from where it started to other areas of the body, or the cancer has come back after a period of time. To answer this question, the researchers will collect information from patients who are taking larotrectinib as prescribed by their doctors. The researchers will learn what adverse events the patients are having. An adverse event is any medical problem that a patient has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The study will include patients of all ages with TRK fusion cancer. In this study, there will be no required tests or visits to a study site. Instead, the researchers will collect information from: * the patients' medical records * interviews with the patients or their parents or guardians * the patients' visits to their doctor as part of their usual care The researchers will collect information about the adults for up to about 2 years and about the children for up to about 8 years.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
20 Jun 2021
Start date
5 Nov 2021
Primary completion date
30 Jun 2029
Lead sponsor
Bayer
NCT number
NCT04945330

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 5 Nov 2021 to the primary completion date, 30 Jun 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Participation in an investigational program with interventions outside of routine clinical practice

Who the study is looking for

  • Patients who are treated with larotrectinib or decided to be treated with larotrectinib, under routine clinical practice.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Many locations
Coordinator of this site? Confirm its status
Multiple LocationsJapanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.