NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes
- Conditions
- Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion
- Interventions
- Registration Number
- NCT04945330
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Soft tissue sarcoma (STS) Larotrectinib (Vitrakvi, BAY2757556) Participants with STS cancer. Melanoma Larotrectinib (Vitrakvi, BAY2757556) Participants with Melanoma cancer. Pediatrics Larotrectinib (Vitrakvi, BAY2757556) - Head and neck (H&N) Larotrectinib (Vitrakvi, BAY2757556) Participants with H\&N cancer. Lung Larotrectinib (Vitrakvi, BAY2757556) Participants with lung cancer. Gastrointestinal (GI) Larotrectinib (Vitrakvi, BAY2757556) Participants with GI cancer. Primary central nervous system (CNS) Larotrectinib (Vitrakvi, BAY2757556) Participants with CNS cancer. Others Larotrectinib (Vitrakvi, BAY2757556) -
- Primary Outcome Measures
Name Time Method Seriousness of TEAEs Approximate 8 years Outcome of TEAEs Approximate 8 years Causality assessment of TEAEs Approximate 8 years Frequency of TEAEs Approximate 8 years Severity of treatment emergent adverse events (TEAEs) Approximate 8 years
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) Approximate 8 years Duration of response (DOR) Approximate 8 years Time to response (TTR) Approximate 8 years Progression-free survival (PFS) Approximate 8 years Overall survival (OS) Approximate 8 years Total dose Approximate 8 years Starting and ending dose Approximate 8 years Dose modification during treatment Approximate 8 years Duration of treatment (DOT) Approximate 8 years 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 Approximate 8 years Baseline characteristics Approximate 8 years Including but not limited to: age, NTRK gene, NTRK gene partner, prior therapy (type, number of lines of therapy), other.
Neurological examination (normal/abnormal) Approximate 8 years Change in height from baseline by visit Approximate 8 years Change in weight from baseline by visit Approximate 8 years Developmental milestones abnormalities (normal/abnormal) Approximate 8 years
Trial Locations
- Locations (1)
Many locations
🇯🇵Multiple Locations, Japan