Cabozantinib for Patients With Recurrent or Progressive Meningioma

May 12, 2026 updated by: Baptist Health South Florida

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute at Baptist Health, Inc.
        • Principal Investigator:
          • Rupesh R Kotecha, MD
        • Contact:
        • Contact:
    • New York
      • New York, New York, United States, 100653
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Histologic (preferred) or radiologic diagnosis of meningioma. All World Health Organization (WHO) grades (I, II and III) are allowed.
  2. 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.
  3. Karnofsky Performance Status ≥ 50.

  4. Adequate hematologic function:

    1. Absolute Neutrophil Count ≥ 1.5 × 10^9 / L without granulocyte colony-stimulating factor support.
    2. Platelet Count ≥ 100 × 10^9 / L without transfusion.
    3. Hemoglobin ≥ 9 g/dL without transfusion within 7 days prior to screening assessment.
  5. Adequate renal function: ≥ 30 mL/min according to the Cockcroft-Gault formula.

  6. Adequate hepatic function including:

    1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
    2. Aspartate transaminase (AST) ≤ 3 × ULN without liver metastasis.
    3. Alanine transaminase (ALT) ≤ 3 × ULN without liver metastasis.
    4. AST or ALT ≤ 5 × ULN for patients with liver metastasis.
    5. Patients with known Gilbert's syndrome may be included if total bilirubin ≤ 3 × ULN.
  7. Patients must have measurable disease by RANO meningioma criteria.

  8. Women of childbearing potential must have negative serum pregnancy testing at screening. All women will be considered childbearing potential unless meeting criteria including:

    1. 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.
    2. Documented hysterectomy or bilateral oophorectomy surgery.
    3. Medically confirmed ovarian failure.
    4. 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.
  9. 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.
  10. 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.
  11. Serum albumin ≥ 2.8 g/dL.
  12. Prothrombin time (PT)/International Normalized Ratio (INR) or partial thromboplastin time (PTT) test < 1.3 × the laboratory ULN.

Exclusion Criteria

  1. Prior treatment with cabozantinib.
  2. Patients < 18 years old.
  3. Patients who are pregnant or breast-feeding.
  4. 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.
  5. Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
  6. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) with 2 weeks before first dose of study treatment.
  7. Ejection fraction (EF) ≤ 50% by echocardiogram (ECHO). Multi-gated acquisition scan (MUGA) should be obtained to estimate EF if quality of ECHO is insufficient.
  8. Prior history of hypertensive encephalopathy at any time.
  9. History of congenital QT syndrome.
  10. 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.
  11. Unstable cardiac arrhythmia within 6 months prior to study registration date.
  12. Urine Protein-to-Creatinine ratio (UPCR) >1 mg/mg or 24-hour urine protein > 1 gram.
  13. History of bleeding diathesis or significant unexplained coagulopathy (e.g., in the absence of anticoagulation).
  14. Clinical signs or symptoms of gastrointestinal obstruction requiring parenteral hydration, nutrition or feeding tube.
  15. Uncontrolled effusion management (pleural effusion, pericardial effusion or ascites) requiring recurrent drainage procedures.
  16. Active infection requiring parenteral antibiotic therapy.
  17. 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.
  18. Serious non-healing wound, ulcer, or bone fracture requiring intervention within 28 days prior to study registration date.
  19. Known hypersensitivity to cabozantinib or any component in formulation.
  20. Inability to swallow capsules, known intolerance to cabozantinib or its excipients, known malabsorption syndrome, or other conditions which impair intestinal absorption.
  21. Other severe acute or chronic medical conditions, which may increase study risk per treating investigator's discretion.

  22. 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:

    1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
    2. 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.

  23. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

    a. Cardiovascular disorders: i. Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.

    ii. Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment.

    iii. 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.

    iv. 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.

    b. 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.

    ii. 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.

  24. 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.
  25. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease from another malignancy.

  26. Other clinically significant disorders that would preclude safe study participation.

    1. Serious non-healing wound/ulcer/bone fracture.
    2. Uncompensated/symptomatic hypothyroidism.
    3. Moderate to severe hepatic impairment (Child-Pugh B or C).
  27. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cabozantinib
Participants 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.
Drug: Cabozantinib

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.

Other Names:
  • Cabometyx
  • Cometriq
  • XL184
  • BMS907351

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QOL)
Time Frame: 2 years

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).
2 years
Overall survival (OS)
Time Frame: 2 years
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.
2 years
Objective response rate (ORR)
Time Frame: 2 years
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.
2 years
Percent of participants with adverse events (AEs)
Time Frame: 2 years
Percent of participants who develop AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.
2 years
Percent of participants with Grade 3-5 AEs
Time Frame: 2 years
Percent of participants who develop Grade 3-5 AEs as assessed by CTCAE v5.0 criteria.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baptist Health South Florida

Collaborators

Exelixis

Investigators

  • Principal Investigator: Rupesh Kotecha, M.D., Miami Cancer Institute at Baptist Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-KOT-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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