account_circleRecruiting
Advanced or recurrent solid tumor harboring an NTRK gene fusion
Bayer Identifier:
21793
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
AllAge
NaN - N/ATrial summary
Enrollment Goal
100Trial Dates
November 2021 - December 2029Phase
Phase 4Could I Receive a placebo
NoProducts
Vitrakvi (Larotrectinib, BAY2757556)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many locations | Many locations, Japan |
Recruiting | Many Locations | Many Locations, Japan |
Primary Outcome
- Severity of treatment emergent adverse events (TEAEs)date_rangeTime Frame:Approximate 8 years
- Frequency of TEAEsdate_rangeTime Frame:Approximate 8 years
- Seriousness of TEAEsdate_rangeTime Frame:Approximate 8 years
- Outcome of TEAEsdate_rangeTime Frame:Approximate 8 years
- Causality assessment of TEAEsdate_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 assessmentdate_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 dosedate_rangeTime Frame:Approximate 8 years
- Starting and ending dosedate_rangeTime Frame:Approximate 8 years
- Dose modification during treatmentdate_rangeTime Frame:Approximate 8 years
- Duration of treatment (DOT)date_rangeTime Frame:Approximate 8 years
- Baseline characteristicsIncluding 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 visitdate_rangeTime Frame:Approximate 8 years
- Change in weight from baseline by visitdate_rangeTime Frame:Approximate 8 years
- Developmental milestones abnormalities (normal/abnormal)date_rangeTime Frame:Approximate 8 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A