Ceritinib Treatment for Recurrent Meningiomas

Prior treatment

• Concurrent anticancer therapy (including anti-VEGF or immunotherapy) or investigational drug use within 2 months prior to trial screening.
• Unresolved adverse events of moderate or severe grade related to previous anticancer therapy or investigational drug use.
• Any contraindications to obtaining a brain MRI (e.g. claustrophobia unresponsive to reassurance or low dose of an anxiolytic agent, general metal or tooth implants, etc.).

Other illness

• Active uncontrolled systemic illness.
• Subject has a medical or psychiatric condition which, in the opinion of the investigator, may put the participant at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial.
• Known hypersensitivity or history of severe allergic or anaphylactic reactions to ceritinib or similar compounds (including CYP3A and CYP2C9 modifiers).
• Subject has a history of severe allergic or anaphylactic reaction to any oral medication that contains 1 or more excipients that are also contained in ZYKADIA.
• Subject has known or persistent abuse of medication, drugs, or alcohol according to the Diagnostic and Statistical Manual of Mental Disorders.
• Subject has a history of or ongoing heart disease.

Lab values

• Subject has Congenital long QT Syndrome or a persistent Fridericia-corrected electrocardiogram interval (QTcF) of \>500 msec.

Other

• Unable to swallow capsules without chewing, dividing, crushing or dissolving them.
• Female subjects who are pregnant or breastfeeding.

• Age ≥ 18 years at the time of signing the consent form
• Confirmed recurrence of meningioma (through imaging and histology)
• Clinically assessed Performance Score (KPS) ≥ 70
• Healthy Kidney and Liver function confirmed through blood test
• Life expectancy of ≥ 6 months.
• Signed informed consent for the study
• Willingness and ability to comply with the protocol, study visits and associated treatments, tests, and procedures
• Female subjects that could become pregnant need to either be sexually inactive or use a highly effective contraceptive. (for 14 days prior to the Day 1 until 90 days after the last dose of the study drug)
• Non- vasectomised male subjects and their female partners that could become pregnant need to either be sexually inactive or use a highly effective contraceptive. (for 14 days prior to the Day 1 until 90 days after the last dose of the study drug)
• Male subjects are eligible to enroll if they agree not to donate sperm from the Day 1 visit until 90 days after their last dose of study drug