account_circleRecruiting

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

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - Patients who are treated with larotrectinib or decided to be treated with larotrectinib, under routine clinical practice.
  • -Participation in an investigational program with interventions outside of routine clinical practice

Trial summary

Enrollment Goal
100
Trial Dates
November 2021 - December 2029
Phase
Phase 4
Could I Receive a placebo
No
Products
Vitrakvi (Larotrectinib, BAY2757556)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, Japan
Recruiting
Many LocationsMany Locations, Japan

Primary Outcome

  • Severity of treatment emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Approximate 8 years
  • Frequency of TEAEs
    date_rangeTime Frame:
    Approximate 8 years
  • Seriousness of TEAEs
    date_rangeTime Frame:
    Approximate 8 years
  • Outcome of TEAEs
    date_rangeTime Frame:
    Approximate 8 years
  • Causality assessment of TEAEs
    date_rangeTime Frame:
    Approximate 8 years

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Approximate 8 years
  • Disease control rate (DCR)
    date_rangeTime Frame:
    Approximate 8 years
  • Duration of response (DOR)
    date_rangeTime Frame:
    Approximate 8 years
  • Time to response (TTR)
    date_rangeTime Frame:
    Approximate 8 years
  • Progression-free survival (PFS)
    date_rangeTime Frame:
    Approximate 8 years
  • Overall survival (OS)
    date_rangeTime Frame:
    Approximate 8 years
  • Total dose
    date_rangeTime Frame:
    Approximate 8 years
  • Starting and ending dose
    date_rangeTime Frame:
    Approximate 8 years
  • Dose modification during treatment
    date_rangeTime Frame:
    Approximate 8 years
  • Duration of treatment (DOT)
    date_rangeTime Frame:
    Approximate 8 years
  • Baseline characteristics
    Including but not limited to: age, NTRK gene, NTRK gene partner, prior therapy (type, number of lines of therapy), other.
    date_rangeTime Frame:
    Approximate 8 years
  • Neurological examination (normal/abnormal)
    date_rangeTime Frame:
    Approximate 8 years
  • Change in height from baseline by visit
    date_rangeTime Frame:
    Approximate 8 years
  • Change in weight from baseline by visit
    date_rangeTime Frame:
    Approximate 8 years
  • Developmental milestones abnormalities (normal/abnormal)
    date_rangeTime Frame:
    Approximate 8 years

Trial design

Special Drug Use Investigation for Larotrectinib
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A