Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05425004

Cabozantinib for Patients With Recurrent or Progressive Meningioma

Led by Baptist Health South Florida · Updated on 2026-05-14

24

Participants Needed

3

Research Sites

308 weeks

Total Duration

On this page

Sponsors

B

Baptist Health South Florida

Lead Sponsor

E

Exelixis

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Cabozantinib for Patients With Recurrent or Progressive Meningioma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic or radiologic diagnosis of meningioma of any WHO grade (I, II, or III)
  • Recurrent or progressive disease after standard therapy more than 6 months ago or ineligible for such therapies
  • Karnofsky Performance Status of 50 or higher
  • Adequate blood cell counts (ANC ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Hemoglobin ≥ 9 g/dL)
  • Adequate kidney function (≥ 30 mL/min by Cockcroft-Gault formula)
  • Adequate liver function with specified limits on bilirubin and liver enzymes
  • Measurable disease by RANO meningioma criteria
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and for 4 months after the study
  • Recovery from prior treatment toxicities to Grade 1 or less unless clinically non-significant
  • Willingness and ability to follow the study protocol and procedures
  • Serum albumin ≥ 2.8 g/dL
  • Prothrombin time/INR or PTT less than 1.3 times the laboratory upper limit of normal
Not Eligible

You will not qualify if you...

  • Prior treatment with cabozantinib
  • Under 18 years of age
  • Pregnant or breastfeeding
  • Any other active malignancy requiring treatment within 3 years except certain cured skin or in situ cancers
  • Received systemic anticancer therapy within 4 weeks before study treatment
  • Received small molecule kinase inhibitors within 2 weeks before study treatment
  • Ejection fraction ≤ 50%
  • History of hypertensive encephalopathy
  • History of congenital QT syndrome
  • Corrected QT interval > 500 ms within 14 days of registration
  • Unstable cardiac arrhythmia within 6 months prior to registration
  • Urine protein-to-creatinine ratio >1 mg/mg or 24-hour urine protein >1 gram
  • History of bleeding disorders or significant unexplained coagulopathy
  • Gastrointestinal obstruction needing parenteral support
  • Uncontrolled effusions requiring repeated drainage
  • Active infection needing intravenous antibiotics
  • Positive hepatitis B or C infection
  • Recent serious non-healing wounds, ulcers, or fractures
  • Known allergy or intolerance to cabozantinib or its ingredients
  • Inability to swallow capsules or conditions impairing absorption
  • Other severe medical conditions increasing risk per investigator
  • Use of certain anticoagulants except specified allowed medications
  • Uncontrolled significant illnesses including serious heart conditions or uncontrolled hypertension
  • Recent stroke, heart attack, or thromboembolic event within 6 months
  • Gastrointestinal disorders with high risk of perforation or fistula within 6 months
  • Significant recent bleeding within 12 weeks
  • Cavitating lung lesions or airway disease from another cancer
  • Clinically significant disorders precluding safe participation
  • Major surgery within 2 weeks or minor surgery within 10 days before study treatment without complete healing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States, 33176

Actively Recruiting

2

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 100653

Actively Recruiting

3

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

R

Rupesh Kotecha, M.D.

CONTACT

A

Anais Vega

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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