NCT05425004 · Baptist Health South Florida
Cabozantinib for Patients With Recurrent or Progressive Meningioma
What this study is about
A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma
View original scientific description
A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 x 10\^9 / L without granulocyte colony-stimulating factor support. 2. Platelet Count ≥ 100 x 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 x upper limit of normal (ULN). 2. Aspartate transaminase (AST) ≤ 3 x ULN without liver metastasis. 3. Alanine transaminase (ALT) ≤ 3 x ULN with
Where
- Miami, Florida
- New York, New York
- Nashville, Tennessee
Collaborators
Exelixis
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations