Ceritinib Treatment for Recurrent Meningiomas

NCT07893197 | Not Yet Recruiting Phase 2

• 1 other identifier: CURE-M
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, patients with recurrent grade I and grade II meningiomas will receive a daily dose of ceritinib for abour two years. Patients will visit the clinic on average about every 2 months for assessments. The objectives of the trial are 1) to analyse if ceritinib can slow or stop tumor recurrence and progression; 2)to investigate how safe ceritinib is in this group of patients.

Conditions

Recurrent Meningioma, Grade I and Grade II

Keywords

meningioma; brain tumor; recurrent meningioma

Outcome Measures

Primary Outcomes (3)

• Progression-free survival (PFS)

  Response Evaluation Criteria in Solid Tumors (RECIST 1.1) applied to MRIs (Axial, pre- and post- gadolinium-enhanced 3D T1-weighted IR-GRE with \<1mm resolution) at each study visit

  From enrolment to safety follow up at week 90

• Investigator-assessed Overall Response Rate (ORR)

  Response Evaluation Criteria in Solid Tumors (RECIST 1.1) applied to magnetic resonant imaging (MRIs) (Axial, pre- and post- gadolinium-enhanced 3D T1-weighted IR-GRE with \<1mm resolution) at each study visit

  From enrolment to safety follow up at week 90

• Overall Survival of patients with recurrent grade 1 or 2 meningioma

  Overall survival is defined as the period from the baseline visit (V1) until death.

  From enrolment to safety follow up at week 90

Secondary Outcomes (32)

• Incidence of Severe Adverse Events related to the study drug

  From enrolment to safety follow up at week 90

• Incidence of Adverse Events related to the study drug

  From enrolment to safety follow up at week 90

• Liver toxicology panel measured in blood (AST, ALT, ALP, total bilirubin)

  From enrolment to safety follow up at week 90

• Calcium in blood serum

  From enrolment to safety follow up at week 90

• Total White Blood Cell Count in Blood

  From enrolment to safety follow up at week 90

Study Arms (1)

Recurrent Meningiomas, Grade I and Grade II

EXPERIMENTAL

Drug: Ceritinib

Interventions

Ceritinib DRUG

450mg daily with food

Recurrent Meningiomas, Grade I and Grade II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active uncontrolled systemic illness.
• 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.
• 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.
• Unable to swallow capsules without chewing, dividing, crushing or dissolving them.
• 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.).
• Subject has a history of or ongoing heart disease.
• Female subjects who are pregnant or breastfeeding.
• Subject has Congenital long QT Syndrome or a persistent Fridericia-corrected electrocardiogram interval (QTcF) of \>500 msec.

Sponsors & Collaborators

• Kevin Petrecca: lead

Study Sites (1)

Montreal Neurological Institute-Hospital

Montreal, Canada

Location

MeSH Terms

Conditions

Meningioma; Lymphoma, Follicular; Brain Neoplasms

Interventions

ceritinib

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Emilie Tsiolis

CONTACT

514-396-1697; bt-cru.neuro@mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Neurosurgery

Study Record Dates

• First Submitted: October 7, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

CA (1)