NCT04945330 NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes
| NCT ID | NCT04945330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bayer |
| Condition | Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-11-05 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-11-05 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04945330 clinical trial?
This trial is open to participants of all sexes, studying Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04945330 currently recruiting?
Yes, NCT04945330 is actively recruiting participants. Contact the research team at clinical-trials-contact@bayer.com for enrollment information.
Where is the NCT04945330 trial being conducted?
This trial is being conducted at Multiple Locations, Japan.
Who is sponsoring the NCT04945330 clinical trial?
NCT04945330 is sponsored by Bayer. The trial plans to enroll 100 participants.