Study Overview: This trial explores the effectiveness of ensartinib, a medication that may help stop tumor growth, for young patients with certain advanced cancers. These cancers have either returned or do not respond to standard treatments and may have spread in the body.
Primary Objective: The study aims to determine how well patients respond to ensartinib, by measuring complete or partial tumor reduction.
Key Points:
- Participation involves taking ensartinib daily for up to 2 years. Regular scans and blood tests are required.
- Patients will be monitored for side effects and checked for how well the drug is tolerated.
- After completing the study, participants are followed up for 30 days.
Eligibility: Patients aged 12 months to 21 years with certain genetic changes in their cancer (ALK or ROS1 alterations) can participate. They must meet specific health criteria, like having a certain body size and cancer that can be measured through scans. Participants must not be pregnant and should agree to use contraception.
Exclusion: Patients with uncontrolled infections, prior organ transplants, or those on certain medications are not eligible. Compliance with study requirements is necessary for participation.