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Not yet recruitingNCT07893197CURE-MUpdated Oct 23, 2026

Ceritinib Treatment for Recurrent Meningiomas

A Phase 2 interventional study of Ceritinib in Recurrent Meningioma, Grade I and Grade II, sponsored by Kevin Petrecca. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Kevin Petrecca · Phase 2, Interventional, and Treatment

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Recurrent Meningioma, Grade I and Grade II

Keywords

  • meningioma
  • brain tumor
  • recurrent meningioma
03

In context

Meningioma

233 studies on the registry are indexed under Meningioma; 90 are open to participants now.

This study's planned enrollment of 10 is below the median of 40 across 167 interventional studies indexed under Meningioma.

Browse Meningioma studies →

Lead sponsor

This is the only study on the registry with Kevin Petrecca as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years at the time of signing the consent form
  2. Confirmed recurrence of meningioma (through imaging and histology)
  3. Clinically assessed Performance Score (KPS) ≥ 70
  4. Healthy Kidney and Liver function confirmed through blood test
  5. Life expectancy of ≥ 6 months.
  6. Signed informed consent for the study
  7. Willingness and ability to comply with the protocol, study visits and associated treatments, tests, and procedures
  8. 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)
  9. 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)
  10. 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

Exclusion criteria

Exclusion Criteria:

  1. Active uncontrolled systemic illness.
  2. Concurrent anticancer therapy (including anti-VEGF or immunotherapy) or investigational drug use within 2 months prior to trial screening.
  3. Unresolved adverse events of moderate or severe grade related to previous anticancer therapy or investigational drug use.
  4. 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.
  5. Known hypersensitivity or history of severe allergic or anaphylactic reactions to ceritinib or similar compounds (including CYP3A and CYP2C9 modifiers).
  6. 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.
  7. Subject has known or persistent abuse of medication, drugs, or alcohol according to the Diagnostic and Statistical Manual of Mental Disorders.
  8. Unable to swallow capsules without chewing, dividing, crushing or dissolving them.
  9. 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.).
  10. Subject has a history of or ongoing heart disease.
  11. Female subjects who are pregnant or breastfeeding.
  12. Subject has Congenital long QT Syndrome or a persistent Fridericia-corrected electrocardiogram interval (QTcF) of >500 msec.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Recurrent Meningiomas, Grade I and Grade II

    Drug: Ceritinib

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From enrolment to safety follow up at week 90

  2. 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

    Time frame: From enrolment to safety follow up at week 90

  3. 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.

    Time frame: From enrolment to safety follow up at week 90

Secondary outcomes

  1. 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.

    Time frame: From enrolment to safety follow up at week 90

  2. 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.

    Time frame: From enrolment to safety follow up at week 90

  3. 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)

    Time frame: From enrolment to safety follow up at week 90

  4. Calcium in blood serum

    Reference range for calcium concentration in serum: 2.12-2.62 mml/L

    Time frame: From enrolment to safety follow up at week 90

  5. 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).

    Time frame: From enrolment to safety follow up at week 90

  6. Serum Lipase

    Determined in serum. Reference range: 14-45 umol/L

    Time frame: From enrolment to safety follow up at week 90

  7. 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)

    Time frame: From enrolment to safety follow up at week 90

  8. Urinalysis- Visual inspection

    Determine urine color(normal urine is pale yellow, clarity (normal urine is clear), odor (small, neutral)

    Time frame: From enrolment to safety follow up at week 90

  9. 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%)

    Time frame: From enrolment to safety follow up at week 90

  10. 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.

    Time frame: From enrolment to safety follow up at week 90

  11. Electrocardiogram

    Measures electrical activity of the heart looking at electrical timing and wave patterns (changes of voltage over time)

    Time frame: From enrolment to safety follow up at week 90

  12. 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").

    Time frame: From enrolment to safety follow up at week 90

  13. 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.

    Time frame: From enrolment to safety follow up at week 90

  14. Red Blood Cell Count

    Reference range: 4-5.1 10\^12/L

    Time frame: From enrolment to safety follow up at week 90

  15. Platelet count in blood

    Refererence range: 140-450 10\^9/L

    Time frame: From enrolment to safety follow up at week 90

  16. Hemoglobin in blood

    Reference range: Female:120-160 g/L, Male: 135-175 g/L

    Time frame: From enrolment to safety follow up at week 90

  17. body temperature

    Unit: degrees Celsius, °C

    Time frame: From enrolment to safety follow up at week 90

  18. pulse rate

    unit: beats/minute

    Time frame: From enrolment to safety follow up at week 90

  19. systolic and diastolic blood pressure

    Unit: mmHg

    Time frame: From enrolment to safety follow up at week 90

  20. pulse oximetry

    Unit: blood oxygen saturation (SpO₂)

    Time frame: From enrolment to safety follow up at week 90

  21. respiratory rate

    unit: breaths/min

    Time frame: From enrolment to safety follow up at week 90

  22. 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.

    Time frame: From enrolment to safety follow up at week 90

  23. Magnesium in serum

    Reference range: 0.75 - 1.05 mml/L

    Time frame: From enrolment to safety follow up at week 90

  24. Chloride in serum

    reference range: 100-109 mmol/L

    Time frame: From enrolment to safety follow up at week 90

  25. Potassium in Serum

    Reference range: 3.5-5 mmol/L

    Time frame: From enrolment to safety follow up at week 90

  26. Sodium in serum

    reference range: 133 - 143 mmol/L

    Time frame: From enrolment to safety follow up at week 90

  27. Bicarbonate in serum

    Reference range: 23 - 29 mmol/L

    Time frame: From enrolment to safety follow up at week 90

  28. Creatine kinase

    Female: 24 - 160 U/L, Male: 24 - 195 U/L

    Time frame: From enrolment to safety follow up at week 90

  29. Random glucose in serum

    Reference range: 3.9 - 11 mmol/L

    Time frame: From enrolment to safety follow up at week 90

  30. Total protein in blood

    Reference range: 60 - 80 g/L

    Time frame: From enrolment to safety follow up at week 90

  31. direct bilirubin in blood

    Reference range: 1.7 - 8.6 umol/L

    Time frame: From enrolment to safety follow up at week 90

  32. total bilirubin in blood

    Reference range: 1.7 - 18.9 umol/L

    Time frame: From enrolment to safety follow up at week 90

07

Study locations

1 site
  • Montreal Neurological Institute-Hospital
    Montreal, Canada
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jan 2031, 48 months later.

Of 34 phase 2 interventional studies under Meningioma, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 108. This study's planned 48 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2026
First posted
Oct 23, 2026
StartEst.
Jan 2027
Primary completionEst.
Jan 2031
CompletionEst.
Jan 2031
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07893197
Lead sponsor
Kevin Petrecca
Responsible party
Kevin Petrecca (Chief of Neurosurgery, McGill University) — Sponsor-investigator
First posted
Oct 23, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2031 (estimated)
Completion
Jan 2031 (estimated)
Last update
Oct 23, 2026

Study contacts

Emilie Tsiolis
Contact
bt-cru.neuro@mcgill.ca
514-396-1697

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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