Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||12 Years and Over|
- - Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion identified through molecular assays.
- - Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
- - Subjects must have at least one measurable lesion as defined by RECIST v1.1.
- - Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK.
- - Symptomatic or unstable brain metastases.
- - Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease, or other systemic disease that would limit compliance with study procedures.
- - Pregnancy or lactation.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Solid Tumors Harboring NTRK Fusion|
The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumors harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1-3 in children and adults. Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumor types.
Experimental: Arm 1_NSCLC
Patients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions (arm closed)
Experimental: Arm 2_Thyroid
Patients with solid thyroid tumors harboring NTRK fusions (arm closed)
Experimental: Arm 3_Sarcoma
Patients with soft-tissue sarcoma harboring NTRK fusions (arm closed)
Experimental: Arm 4_Colorectal
Patients with solid colorectal tumors harboring NTRK fusions
Experimental: Arm 5_Salivary
Patients with solid salivary tumors harboring NTRK fusions (arm closed)
Experimental: Arm 6_Biliary
Patients with solid biliary tumors harboring NTRK fusions (arm closed)
Experimental: Arm 7_Primary CNS
Patients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions (arm closed)
Experimental: Arm 8_Other tumors
Patients with e.g. kidney cancer, squamous cell cancer of head or neck or ovarian solid tumors harboring NTRK fusions
Experimental: Arm 9_Solid tumors without confirmed NTRK fusion
Patients eligible for arms 1 to 8, but with documented NTRK fusion from a laboratory where CLIA or equivalent certification cannot be confirmed by the sponsor at the time of consent (arm closed)
Experimental: Arm 10_Lung cancer
Patients with lung cancer harboring NTRK fusions
Experimental: Arm 11_Melanoma
Patients with melanoma harboring NTRK fusions
Experimental: Arm 12_Breast cancer
Patient with non-secretory breast cancer harboring NTRK fusions
Drug: - BAY2757556 (Larotrectinib, Vitrakvi)
Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.