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MeningiomaPhase 2NCT05425004

Cabozantinib for Patients With Recurrent or Progressive Meningioma

A Phase 2 study testing Cabozantinib in people with Meningioma, run by Baptist Health South Florida at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meningioma
What is being tested?
Cabozantinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesUnited States
Study dates
1 Jun 2022to May 2028
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

  • Histologic (preferred) or radiologic diagnosis of meningioma. All World Health Organization (WHO) grades (I, II and III) are allowed.
  • All patients must have developed recurrent disease or progressive disease after receiving standard therapy (e.g., radiation or surgery) > 6 months ago or have been deemed ineligible to receive these therapies.
  • Karnofsky Performance Status ≥ 50.
  • Adequate hematologic function:
  • Absolute Neutrophil Count ≥ 1.5 × 10^9 / L without granulocyte colony-stimulating factor support.
  • Platelet Count ≥ 100 × 10^9 / L without transfusion.
Show all 24Show fewer
  • Hemoglobin ≥ 9 g/dL without transfusion within 7 days prior to screening assessment.
  • Adequate renal function: ≥ 30 mL/min according to the Cockcroft-Gault formula.
  • Adequate hepatic function including:
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
  • Aspartate transaminase (AST) ≤ 3 × ULN without liver metastasis.
  • Alanine transaminase (ALT) ≤ 3 × ULN without liver metastasis.
  • AST or ALT ≤ 5 × ULN for patients with liver metastasis.
  • Patients with known Gilbert's syndrome may be included if total bilirubin ≤ 3 × ULN.
  • Patients must have measurable disease by RANO meningioma criteria.
  • Women of childbearing potential must have negative serum pregnancy testing at screening. All women will be considered childbearing potential unless meeting criteria including:
  • Achieved post-menopausal status as defined by cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have follicular stimulation hormone showing postmenopausal state. Women who have been amenorrhoeic for ≥ 12 months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anorexia, low body weight, ovarian suppression, anti-estrogen therapy or other medically inducible reasons.
  • Documented hysterectomy or bilateral oophorectomy surgery.
  • Medically confirmed ovarian failure.
  • Sexually active participants and their partners must agree to use medically accepted methods of contraception during the study and for 4 months after discontinuing study treatment.
  • Recovery of baseline CTCAE v5.0 Grade ≤ 1 toxicity related to prior study treatments unless adverse events are clinically non-significant per investigator's discretion and/or stable on supportive therapy if needed.
  • Patients must be willing and able to comply with trial protocol. This includes adhering to the treatment plan, scheduled visits, laboratory and other study procedures.
  • Serum albumin ≥ 2.8 g/dL.
  • Prothrombin time (PT)/International Normalized Ratio (INR) or partial thromboplastin time (PTT) test < 1.3 × the laboratory ULN.

Who cannot join

  • Prior treatment with cabozantinib.
  • Patients < 18 years old.
  • Patients who are pregnant or breast-feeding.
  • 4. Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  • Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
  • Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) with 2 weeks before first dose of study treatment.
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  • Ejection fraction (EF) ≤ 50% by echocardiogram (ECHO). Multi-gated acquisition scan (MUGA) should be obtained to estimate EF if quality of ECHO is insufficient.
  • Prior history of hypertensive encephalopathy at any time.
  • History of congenital QT syndrome.
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 14 days of study registration. If initial QTcF is > 500 ms, two additional EKGs separated by at least 3 minutes should be performed, and if average of these consecutive results is QTcF is ≤ 500 ms, patient is eligible.
  • Unstable cardiac arrhythmia within 6 months prior to study registration date.
  • Urine Protein-to-Creatinine ratio (UPCR) >1 mg/mg or 24-hour urine protein > 1 gram.
  • History of bleeding diathesis or significant unexplained coagulopathy (e.g., in the absence of anticoagulation).
  • Clinical signs or symptoms of gastrointestinal obstruction requiring parenteral hydration, nutrition or feeding tube.
  • Uncontrolled effusion management (pleural effusion, pericardial effusion or ascites) requiring recurrent drainage procedures.
  • Active infection requiring parenteral antibiotic therapy.
  • History of either positive hepatitis C virus (HCV) RNA viral load or detectable anti-HCV antibody; hepatitis B virus (HBV) infection with HBV surface antigen detection and/or positive HBV DNA viral load.
  • Serious non-healing wound, ulcer, or bone fracture requiring intervention within 28 days prior to study registration date.
  • Known hypersensitivity to cabozantinib or any component in formulation.
  • Inability to swallow capsules, known intolerance to cabozantinib or its excipients, known malabsorption syndrome, or other conditions which impair intestinal absorption.
  • Other severe acute or chronic medical conditions, which may increase study risk per treating investigator's discretion.
  • Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
  • Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
  • Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders: i. Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
  • Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment.
  • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.
  • Subjects with a diagnosis of incidental, sub-segmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #6) for at least 1 week before first dose of study treatment.
  • Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: i. The subject has evidence of any concurrent malignancy invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.
  • Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.
  • Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.
  • Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.
  • Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease from another malignancy.
  • Other clinically significant disorders that would preclude safe study participation.
  • Serious non-healing wound/ulcer/bone fracture.
  • Uncompensated/symptomatic hypothyroidism.
  • Moderate to severe hepatic impairment (Child-Pugh B or C).
  • Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rupesh Kotecha, M.D. contact

(786) 596-2000

RupeshK@baptisthealth.net

Anais Vega contact

(786) 596-2000

anais.vega@baptisthealth.net

United States3 sites, 3 recruiting

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

    Rupesh Kotecha, M.D., 786-596-2000, RupeshK@baptisthealth.net

    Anais Vega, (786) 596-2000, anais.vega@baptisthealth.net

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Alexander Mohler, M.D., 615-936-8422, alexander.mohler@vumc.org

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 100653

    Thomas Kaley, M.D., 212-639-5122, kaleyt@mskcc.org

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Study of Cabozantinib for Patients With Recurrent or Progressive Meningioma

A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma

Conditions
Meningioma
Being tested
Cabozantinib
Keywords
Meningioma, central nervous system tumors, Recurrent meningioma, Progression meningioma
Medical subject headings
Meningioma, Central Nervous System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabozantinibDrug

    Also called XL184, Cometriq, Cabometyx, BMS907351

    Cabozantinib tablets are supplied as film coated tablets containing cabozantinib malate equivalent to 20 mg and 60 mg of cabozantinib and contain microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry® yellow. The 60 mg tablets are oval and the 20 mg tablets are round. Doses of 40 mg will comprise two 20-mg tablets.

    The starting dose for all participants is 60 mg per day by mouth. The study doctor may reduce a participant's dose to 40 mg per day, 20 mg per day, or 20 mg every other day depending on severity of side effects. The study doctor may also increase the dose back up to 60 mg per day if side effects improve.

Study groups in NCT05425004
Study groupRoleWhat they receive
CabozantinibExperimentalParticipants will self-administer cabozantinib 60 mg at the same time daily by mouth on a continuous 28-day schedule. Participants will continue to take this medication as long as they are deriving benefit from it without significant treatment-related toxicities.
Receives: Drug: Cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    PFS is defined as the proportion of participants who from the start of treatment are free from objective tumor progression or death from any cause at 6 months. Tumor response and progression will be assessed using Response Assessment in Neuro-Oncology (RANO) meningioma criteria. Progressive disease (PD) is defined as the presence of any of the following criteria: ≥ 25% increase in target lesion area relative to nadir, unequivocal progression of any nontarget lesion, presence of new lesions, or worsening clinical status. Participants without documented progression or death by 6 months will be censored at the date of their last adequate disease assessment. Those who discontinue early or are lost to follow-up prior to 6 months without a progression event will be censored at their last tumor assessment. Suspected but unconfirmed progression will not be counted as an event unless subsequently confirmed.

    Measured: 6 months

Secondary outcomes (5)

  1. Objective response rate (ORR)

    ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) assessed by RANO meningioma criteria, from the start of treatment to two years. CR is defined as the disappearance of all target and non-target lesions, no new lesions, no use of corticosteroids, and stable or improved clinical status. PR is defined as ≥ 50% decrease in target lesion area relative to baseline, stable or improved non-target lesions, no new lesions, stable or decreased use of corticosteroids, and stable or improved clinical status.

    Measured: 2 years

  2. Overall survival (OS)

    Overall Survival (OS): duration of time from start of treatment until death from any cause. Patients lost-to follow up will be censored at last valid assessment.

    Measured: 2 years

  3. Percent of participants with adverse events (AEs)

    Percent of participants who develop AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.

    Measured: 2 years

  4. Percent of participants with Grade 3-5 AEs

    Percent of participants who develop Grade 3-5 AEs as assessed by CTCAE v5.0 criteria.

    Measured: 2 years

  5. Quality of life (QOL)

    QOL will be measured by Functional Assessment of Cancer Therapy-Brain (FACT-Br) Version 4. The FACT-Br questionnaire is a 23-item survey, participants then rate each item on a Likert scale from 0 "not at all" to 4 "very much", and overall, higher ratings are suggestive of better quality of life.

    QOL will be assessed at the baseline, day 1 of every cycle (treatment days, every 4 weeks on 28-day cycle, and every 6 weeks on 42-day cycle).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start1 Jun 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425004
Sponsor's protocol ID
2020-KOT-002
Status last verified
May 2026
First submitted
15 Jun 2022
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rogers CL, Won M, Vogelbaum MA, Perry A, Ashby LS, Modi JM, Alleman AM, Galvin J, Fogh SE, Youssef E, Deb N, Kwok Y, Robinson CG, Shu HK, Fisher BJ, Panet-Raymond V, McMillan WG, de Groot JF, Zhang P, Mehta MP. High-risk Meningioma: Initial Outcomes From NRG Oncology/RTOG 0539. Int J Radiat Oncol Biol Phys. 2020 Mar 15;106(4):790-799. doi: 10.1016/j.ijrobp.2019.11.028. Epub 2019 Nov 29.

    PubMed 31786276

  • Jaaskelainen J, Haltia M, Servo A. Atypical and anaplastic meningiomas: radiology, surgery, radiotherapy, and outcome. Surg Neurol. 1986 Mar;25(3):233-42. doi: 10.1016/0090-3019(86)90233-8.

    PubMed 3945904

  • Perry A, Scheithauer BW, Stafford SL, Lohse CM, Wollan PC. "Malignancy" in meningiomas: a clinicopathologic study of 116 patients, with grading implications. Cancer. 1999 May 1;85(9):2046-56. doi: 10.1002/(sici)1097-0142(19990501)85:93.0.co;2-m.

    PubMed 10223247

  • Perry A, Stafford SL, Scheithauer BW, Suman VJ, Lohse CM. Meningioma grading: an analysis of histologic parameters. Am J Surg Pathol. 1997 Dec;21(12):1455-65. doi: 10.1097/00000478-199712000-00008.

    PubMed 9414189

  • Preusser M, Brastianos PK, Mawrin C. Advances in meningioma genetics: novel therapeutic opportunities. Nat Rev Neurol. 2018 Feb;14(2):106-115. doi: 10.1038/nrneurol.2017.168. Epub 2018 Jan 5.

    PubMed 29302064

  • Yun S, Koh JM, Lee KS, Seo AN, Nam KH, Choe G. Expression of c-MET in Invasive Meningioma. J Pathol Transl Med. 2015 Jan;49(1):44-51. doi: 10.4132/jptm.2014.10.13. Epub 2015 Jan 15.

    PubMed 25812657

  • Kaley TJ, Wen P, Schiff D, Ligon K, Haidar S, Karimi S, Lassman AB, Nolan CP, DeAngelis LM, Gavrilovic I, Norden A, Drappatz J, Lee EQ, Purow B, Plotkin SR, Batchelor T, Abrey LE, Omuro A. Phase II trial of sunitinib for recurrent and progressive atypical and anaplastic meningioma. Neuro Oncol. 2015 Jan;17(1):116-21. doi: 10.1093/neuonc/nou148. Epub 2014 Aug 6.

    PubMed 25100872

  • Chevreau C, Ravaud A, Escudier B, Amela E, Delva R, Rolland F, Tosi D, Oudard S, Blanc E, Ferlay C, Negrier S; French Group on Renal Cancer. A phase II trial of sunitinib in patients with renal cell cancer and untreated brain metastases. Clin Genitourin Cancer. 2014 Feb;12(1):50-4. doi: 10.1016/j.clgc.2013.09.008. Epub 2013 Sep 28.

    PubMed 24268852

  • Ma PC, Tretiakova MS, MacKinnon AC, Ramnath N, Johnson C, Dietrich S, Seiwert T, Christensen JG, Jagadeeswaran R, Krausz T, Vokes EE, Husain AN, Salgia R. Expression and mutational analysis of MET in human solid cancers. Genes Chromosomes Cancer. 2008 Dec;47(12):1025-37. doi: 10.1002/gcc.20604.

    PubMed 18709663

  • Wen PY, Drappatz J, de Groot J, Prados MD, Reardon DA, Schiff D, Chamberlain M, Mikkelsen T, Desjardins A, Holland J, Ping J, Weitzman R, Cloughesy TF. Phase II study of cabozantinib in patients with progressive glioblastoma: subset analysis of patients naive to antiangiogenic therapy. Neuro Oncol. 2018 Jan 22;20(2):249-258. doi: 10.1093/neuonc/nox154.

    PubMed 29016998

  • Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F, Hammers H, Hutson TE, Lee JL, Peltola K, Roth BJ, Bjarnason GA, Geczi L, Keam B, Maroto P, Heng DY, Schmidinger M, Kantoff PW, Borgman-Hagey A, Hessel C, Scheffold C, Schwab GM, Tannir NM, Motzer RJ; METEOR Investigators. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1814-23. doi: 10.1056/NEJMoa1510016. Epub 2015 Sep 25.

    PubMed 26406150

  • Choueiri TK, Escudier B, Powles T, Tannir NM, Mainwaring PN, Rini BI, Hammers HJ, Donskov F, Roth BJ, Peltola K, Lee JL, Heng DYC, Schmidinger M, Agarwal N, Sternberg CN, McDermott DF, Aftab DT, Hessel C, Scheffold C, Schwab G, Hutson TE, Pal S, Motzer RJ; METEOR investigators. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):917-927. doi: 10.1016/S1470-2045(16)30107-3. Epub 2016 Jun 5.

    PubMed 27279544

  • Escudier B, Powles T, Motzer RJ, Olencki T, Aren Frontera O, Oudard S, Rolland F, Tomczak P, Castellano D, Appleman LJ, Drabkin H, Vaena D, Milwee S, Youkstetter J, Lougheed JC, Bracarda S, Choueiri TK. Cabozantinib, a New Standard of Care for Patients With Advanced Renal Cell Carcinoma and Bone Metastases? Subgroup Analysis of the METEOR Trial. J Clin Oncol. 2018 Mar 10;36(8):765-772. doi: 10.1200/JCO.2017.74.7352. Epub 2018 Jan 8.

    PubMed 29309249

  • Choueiri TK, Hessel C, Halabi S, Sanford B, Michaelson MD, Hahn O, Walsh M, Olencki T, Picus J, Small EJ, Dakhil S, Feldman DR, Mangeshkar M, Scheffold C, George D, Morris MJ. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update. Eur J Cancer. 2018 May;94:115-125. doi: 10.1016/j.ejca.2018.02.012. Epub 2018 Mar 20.

    PubMed 29550566

  • Abou-Alfa GK, Meyer T, Cheng AL, El-Khoueiry AB, Rimassa L, Ryoo BY, Cicin I, Merle P, Chen Y, Park JW, Blanc JF, Bolondi L, Klumpen HJ, Chan SL, Zagonel V, Pressiani T, Ryu MH, Venook AP, Hessel C, Borgman-Hagey AE, Schwab G, Kelley RK. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma. N Engl J Med. 2018 Jul 5;379(1):54-63. doi: 10.1056/NEJMoa1717002.

    PubMed 29972759

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib in people with Meningioma, run by Baptist Health South Florida at 3 sites in United States.

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 24 inclusion and 39 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 Rupesh Kotecha, M.D. ((786) 596-2000, RupeshK@baptisthealth.net), 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: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425004, which also lists 19 linked publications.

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 14 May 2026.

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