Trial Condition(s):

Advanced or recurrent solid tumor harboring an NTRK gene fusion

NTRK gene fusion - positive advanced or recurrent solid tumors, a rare cancer caused by specific changes in the genes

Bayer Identifier:

21793

ClinicalTrials.gov Identifier:

NCT04945330

EudraCT Number:

Not Available

Recruiting

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
100
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Vitrakvi (Larotrectinib, BAY2757556)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Japan

Status
Recruiting
 

Trial Design