Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04945330

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Larotrectinib (Vitrakvi, BAY2757556)

Drug

Follow clinical practice

Primary outcomes

  1. Severity of treatment emergent adverse events (TEAEs)

    Time frame: Approximate 8 years

  2. Frequency of TEAEs

    Time frame: Approximate 8 years

  3. Seriousness of TEAEs

    Time frame: Approximate 8 years

  4. Outcome of TEAEs

    Time frame: Approximate 8 years

  5. Causality assessment of TEAEs

    Time frame: Approximate 8 years

Secondary outcomes

  1. Overall response rate (ORR), based on investigator assessment preferably using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Response Assessment in Neuro-Oncology (RANO) as appropriate by local investigator assessment

    Time frame: Approximate 8 years

  2. Disease control rate (DCR)

    Time frame: Approximate 8 years

  3. Duration of response (DOR)

    Time frame: Approximate 8 years

  4. Time to response (TTR)

    Time frame: Approximate 8 years

  5. Progression-free survival (PFS)

    Time frame: Approximate 8 years

  6. Overall survival (OS)

    Time frame: Approximate 8 years

  7. Total dose

    Time frame: Approximate 8 years

  8. Starting and ending dose

    Time frame: Approximate 8 years

  9. Dose modification during treatment

    Time frame: Approximate 8 years

  10. Duration of treatment (DOT)

    Time frame: Approximate 8 years

  11. Baseline characteristics

    Time frame: Approximate 8 years

    Including but not limited to: age, NTRK gene, NTRK gene partner, prior therapy (type, number of lines of therapy), other.

  12. Neurological examination (normal/abnormal)

    Time frame: Approximate 8 years

  13. Change in height from baseline by visit

    Time frame: Approximate 8 years

  14. Change in weight from baseline by visit

    Time frame: Approximate 8 years

  15. Developmental milestones abnormalities (normal/abnormal)

    Time frame: Approximate 8 years

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Special Drug Use Investigation for Larotrectinib

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Jun 30, 2021
Registry last updated
Jul 7, 2026

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.

Published trials that share one or more normalized conditions with this study.