NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Larotrectinib (Vitrakvi, BAY2757556).
- Who it may be relevant to
- Registry conditions: Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Special Drug Use Investigation for Larotrectinib
Overview
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.
Interventions
- Drug Larotrectinib (Vitrakvi, BAY2757556)
Follow clinical practice
Primary outcome measures
- Severity of treatment emergent adverse events (TEAEs) [Time frame: Approximate 8 years]
- Frequency of TEAEs [Time frame: Approximate 8 years]
- Seriousness of TEAEs [Time frame: Approximate 8 years]
- Outcome of TEAEs [Time frame: Approximate 8 years]
- Causality assessment of TEAEs [Time frame: Approximate 8 years]
Secondary outcome measures (12)
- 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]
- Disease control rate (DCR) [Time frame: Approximate 8 years]
- Duration of response (DOR) [Time frame: Approximate 8 years]
- Time to response (TTR) [Time frame: Approximate 8 years]
- Progression-free survival (PFS) [Time frame: Approximate 8 years]
- Overall survival (OS) [Time frame: Approximate 8 years]
- Total dose [Time frame: Approximate 8 years]
- Starting and ending dose [Time frame: Approximate 8 years]
- Dose modification during treatment [Time frame: Approximate 8 years]
- Duration of treatment (DOT) [Time frame: Approximate 8 years]
- Baseline characteristics [Time frame: Approximate 8 years]
- Neurological examination (normal/abnormal) [Time frame: Approximate 8 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Many locations — Multiple Locations
Identifiers
NCT: NCT04945330 · 21793