Study on Entrectinib for Children and Teens with Advanced or Hard-to-Treat Solid or Brain Tumors

Inclusion Criteria

• Have a type of cancer that is advanced, has come back, or cannot be removed by surgery without causing severe problems.
• Have a tumor with specific genetic changes called NTRK1/2/3 or ROS1 gene fusions.
• Have a confirmed diagnosis of cancer, either at the start or when it came back.
• Provide a sample of the tumor tissue from diagnosis or when the cancer returned.
• Be in good general health with a performance score of 60% or higher and a life expectancy of at least 4 weeks.
• Have no other satisfactory treatment options available.
• Have recovered from any side effects of previous cancer treatments.
• Have good organ and nerve function.
• Female participants who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for 90 days after.
• Male participants with partners who can have children must agree to use condoms during the study and for 3 months after.

Exclusion Criteria

• Currently receiving other experimental treatments.
• Have a known heart condition called long QT syndrome.
• Have had recent heart failure or low heart function.
• Have active infections.
• Have a history of bone disorders or problems with bone metabolism.
• Are taking certain epilepsy medications within 14 days of starting the study.
• Have previously been treated with TRK or ROS1 inhibitors.
• Have an allergy to Entrectinib or its ingredients.
• Have a type of cancer called neuroblastoma that only affects the bone marrow.
• Have not fully recovered from recent surgery.
• Have digestive issues that affect drug absorption.
• Have other severe medical or psychiatric conditions that could increase risks or interfere with the study.