Recurrent Meningioma, Grade I and Grade IIPhase 2CURE-MNCT07893197
Ceritinib Treatment for Recurrent Meningiomas
A Phase 2 study testing Ceritinib in people with Recurrent Meningioma, Grade I and Grade II, run by Kevin Petrecca at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Meningioma, Grade I and Grade II
- What is being tested?
- Ceritinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2027to Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Montreal Neurological Institute-Hospital
Montreal
Brain Tumor Clinic, 514-396-1697, bt-cru.neuro@mcgill.ca
About this study
Official title: Ceritinib Use for IGF1-Receptor Inhibition in Meningioma - A Phase 2 Open- Label Study in Recurrent Grade 1 and 2 Tumors
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.
- Being tested
- Ceritinib
- Keywords
- meningioma, brain tumor, recurrent meningioma
- Medical subject headings
- Meningioma, Lymphoma, Follicular, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeritinibDrug
450mg daily with food
| Study group | Role | What they receive |
|---|---|---|
| Recurrent Meningiomas, Grade I and Grade II | Experimental | Not described Receives: Drug: Ceritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: From enrolment to safety follow up at week 90
Secondary outcomes (32)
Incidence of Severe Adverse Events related to the study drug
Grade of Adverse Events classified as per CTCAE v6.0. The higher the grade, the worse and more severe the event.
Measured: From enrolment to safety follow up at week 90
Incidence of Adverse Events related to the study drug
Grade of Adverse Events classified as per CTCAE v6.0. The higher the grade, the worse and more severe the event.
Measured: From enrolment to safety follow up at week 90
Liver toxicology panel measured in blood (AST, ALT, ALP, total bilirubin)
Liver toxicity indicators in blood: Aspertate aminotransferase (AST) (U/L, Reference range: 6-35), Alanine aminotransferase (ALT) (U/L, Reference range: 6-45), total bilirubin (umol/L, 1.7-18.9), alkaline phosphatase (ALP)
Measured: From enrolment to safety follow up at week 90
Calcium in blood serum
Reference range for calcium concentration in serum: 2.12-2.62 mml/L
Measured: From enrolment to safety follow up at week 90
Total White Blood Cell Count in Blood
White Blood Cell Count (Reference Range: 4.5-11 10^9/L). Can be further subdevided into different types of white blood cells including: Neutrophils (1.88-7.7 10^9/L), Lymphocytes (1-4.8 10^9/L), Monocytes (0-0.8 10^9/L), Eosinophils (0-0.45 10^9/L), Basophils (0-0.022 10^9/L).
Measured: From enrolment to safety follow up at week 90
Serum Lipase
Determined in serum. Reference range: 14-45 umol/L
Measured: From enrolment to safety follow up at week 90
Urinalysis-Dipstick
Dipstick measures several values at once: pH (measured in logarithmic units from 0-14, 7 is normal), amount of protein (Normal reference range: under 10-14 mg/dL), glucose (Normal reference range: 0 to 15 mg/dL or 0 to 0.8 mmol/L), ketones (measured in mmol/L), blood (normal: 3 to 4 red blood cells per high power field), nitrites (measured as positive or negative, no scale), leukocyte esterase (measured in leukocytes per microliter)
Measured: From enrolment to safety follow up at week 90
Urinalysis- Visual inspection
Determine urine color(normal urine is pale yellow, clarity (normal urine is clear), odor (small, neutral)
Measured: From enrolment to safety follow up at week 90
Karnofsky Performance Status
Scoring degree of overall abilities and independence as per Shag et al, 1984. Range from "Normal no complaints; no evidence of disease"(100%) to "Dead" (0%)
Measured: From enrolment to safety follow up at week 90
Pregnancy test-Quantitative beta hCG in urine
Measurement to determine pregnancy status in urine, Reference range: 0-4.9 IU/L. Positive test will lead to trial discontinuation.
Measured: From enrolment to safety follow up at week 90
Electrocardiogram
Measures electrical activity of the heart looking at electrical timing and wave patterns (changes of voltage over time)
Measured: From enrolment to safety follow up at week 90
EORTC QLQ-C30 (Version 3)
The 30- question quality-of-life assessment focussing on the well-being and health of the patient. Items 1-28 use a 4-point scale ("Not at All" to "Very Much"); items 29-30 use a 7-point scale ("Very poor" to "Excellent").
Measured: From enrolment to safety follow up at week 90
The Neurologic Assessment in Neuro-Oncology (NANO) scale
Assessing the neurologic function of the patient. Scale ranges from "normal" to "None to very little function" following Nayak et. al, 2017.
Measured: From enrolment to safety follow up at week 90
Red Blood Cell Count
Reference range: 4-5.1 10^12/L
Measured: From enrolment to safety follow up at week 90
Platelet count in blood
Refererence range: 140-450 10^9/L
Measured: From enrolment to safety follow up at week 90
Hemoglobin in blood
Reference range: Female:120-160 g/L, Male: 135-175 g/L
Measured: From enrolment to safety follow up at week 90
body temperature
Unit: degrees Celsius, °C
Measured: From enrolment to safety follow up at week 90
pulse rate
unit: beats/minute
Measured: From enrolment to safety follow up at week 90
systolic and diastolic blood pressure
Unit: mmHg
Measured: From enrolment to safety follow up at week 90
pulse oximetry
Unit: blood oxygen saturation (SpO₂)
Measured: From enrolment to safety follow up at week 90
respiratory rate
unit: breaths/min
Measured: From enrolment to safety follow up at week 90
Barthel Index for Activities of Daily Living
The Barthel Index (after Sinoff et al, 1997) ranks the degree of dependence of patient to perform day-to-day activities. 10 domains assessed include questions on bowel function, bladder function, dressing themselves, mobility.
Measured: From enrolment to safety follow up at week 90
Magnesium in serum
Reference range: 0.75 - 1.05 mml/L
Measured: From enrolment to safety follow up at week 90
Chloride in serum
reference range: 100-109 mmol/L
Measured: From enrolment to safety follow up at week 90
Potassium in Serum
Reference range: 3.5-5 mmol/L
Measured: From enrolment to safety follow up at week 90
Sodium in serum
reference range: 133 - 143 mmol/L
Measured: From enrolment to safety follow up at week 90
Bicarbonate in serum
Reference range: 23 - 29 mmol/L
Measured: From enrolment to safety follow up at week 90
Creatine kinase
Female: 24 - 160 U/L, Male: 24 - 195 U/L
Measured: From enrolment to safety follow up at week 90
Random glucose in serum
Reference range: 3.9 - 11 mmol/L
Measured: From enrolment to safety follow up at week 90
Total protein in blood
Reference range: 60 - 80 g/L
Measured: From enrolment to safety follow up at week 90
direct bilirubin in blood
Reference range: 1.7 - 8.6 umol/L
Measured: From enrolment to safety follow up at week 90
total bilirubin in blood
Reference range: 1.7 - 18.9 umol/L
Measured: From enrolment to safety follow up at week 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Meningioma, Grade I and Grade IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kevin Petrecca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kevin Petrecca, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893197
- Sponsor's protocol ID
- CURE-M
- Acronym
- CURE-M
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceritinib Use for IGF1-Receptor Inhibition in Meningioma - A Phase 2 Open- Label Study in Recurrent Grade 1 and 2 Tumors
- ClinicalTrials.gov ID
- NCT07893197
- Acronym / sponsor ID
- CURE-M / CURE-M
- Keywords
- meningioma, brain tumor, recurrent meningioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kevin PetreccaUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent Meningiomas, Grade I and Grade II | Experimental | Drug: Ceritinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceritinib450mg daily with food | Drug | Recurrent Meningiomas, Grade I and Grade II |
Primary outcome
Progression-free survival (PFS)
Time frame: From enrolment to safety follow up at week 90
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
Investigator-assessed Overall Response Rate (ORR)
Time frame: From enrolment to safety follow up at week 90
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
Overall Survival of patients with recurrent grade 1 or 2 meningioma
Time frame: From enrolment to safety follow up at week 90
Overall survival is defined as the period from the baseline visit (V1) until death.
32 secondary outcomes
Incidence of Severe Adverse Events related to the study drug
Time frame: From enrolment to safety follow up at week 90
Incidence of Adverse Events related to the study drug
Time frame: From enrolment to safety follow up at week 90
Liver toxicology panel measured in blood (AST, ALT, ALP, total bilirubin)
Time frame: From enrolment to safety follow up at week 90
Calcium in blood serum
Time frame: From enrolment to safety follow up at week 90
Total White Blood Cell Count in Blood
Time frame: From enrolment to safety follow up at week 90
Serum Lipase
Time frame: From enrolment to safety follow up at week 90
Urinalysis-Dipstick
Time frame: From enrolment to safety follow up at week 90
Urinalysis- Visual inspection
Time frame: From enrolment to safety follow up at week 90
Karnofsky Performance Status
Time frame: From enrolment to safety follow up at week 90
Pregnancy test-Quantitative beta hCG in urine
Time frame: From enrolment to safety follow up at week 90
Electrocardiogram
Time frame: From enrolment to safety follow up at week 90
EORTC QLQ-C30 (Version 3)
Time frame: From enrolment to safety follow up at week 90
The Neurologic Assessment in Neuro-Oncology (NANO) scale
Time frame: From enrolment to safety follow up at week 90
Red Blood Cell Count
Time frame: From enrolment to safety follow up at week 90
Platelet count in blood
Time frame: From enrolment to safety follow up at week 90
Hemoglobin in blood
Time frame: From enrolment to safety follow up at week 90
body temperature
Time frame: From enrolment to safety follow up at week 90
pulse rate
Time frame: From enrolment to safety follow up at week 90
systolic and diastolic blood pressure
Time frame: From enrolment to safety follow up at week 90
pulse oximetry
Time frame: From enrolment to safety follow up at week 90
respiratory rate
Time frame: From enrolment to safety follow up at week 90
Barthel Index for Activities of Daily Living
Time frame: From enrolment to safety follow up at week 90
Magnesium in serum
Time frame: From enrolment to safety follow up at week 90
Chloride in serum
Time frame: From enrolment to safety follow up at week 90
Potassium in Serum
Time frame: From enrolment to safety follow up at week 90
Sodium in serum
Time frame: From enrolment to safety follow up at week 90
Bicarbonate in serum
Time frame: From enrolment to safety follow up at week 90
Creatine kinase
Time frame: From enrolment to safety follow up at week 90
Random glucose in serum
Time frame: From enrolment to safety follow up at week 90
Total protein in blood
Time frame: From enrolment to safety follow up at week 90
direct bilirubin in blood
Time frame: From enrolment to safety follow up at week 90
total bilirubin in blood
Time frame: From enrolment to safety follow up at week 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ceritinib in people with Recurrent Meningioma, Grade I and Grade II, run by Kevin Petrecca at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie Tsiolis (514-396-1697, bt-cru.neuro@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From enrolment to safety follow up at week 90). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.