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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastrointestinal (GI) | Participants with GI cancer. |
| |
| Head and neck (H&N) | Participants with H&N cancer. |
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| Lung | Participants with lung cancer. |
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| Soft tissue sarcoma (STS) | Participants with STS cancer. |
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| Primary central nervous system (CNS) | Participants with CNS cancer. |
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| Melanoma | Participants with Melanoma cancer. |
| |
| Pediatrics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Larotrectinib (Vitrakvi, BAY2757556) | Drug | Follow clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of treatment emergent adverse events (TEAEs) | Approximate 8 years | |
| Frequency of TEAEs | Approximate 8 years | |
| Seriousness of TEAEs | Approximate 8 years | |
| Outcome of TEAEs | Approximate 8 years | |
| Causality assessment of TEAEs | Approximate 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult and pediatric (from birth to 18 year old) patients treated with larotrectinib.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bayer Clinical Trials Contact | Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Recruiting | Multiple Locations | Japan |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| ID | Term |
|---|---|
| C000609083 | larotrectinib |
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| Others |
|
| 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 |
| Baseline characteristics | Including but not limited to: age, NTRK gene, NTRK gene partner, prior therapy (type, number of lines of therapy), other. | Approximate 8 years |
| 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 |