Cabozantinib for Patients With Recurrent or Progressive Meningioma

NCT05425004 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2020-KOT-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Meningioma

Keywords

Meningioma; central nervous system tumors; Recurrent meningioma; Progression meningioma

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (5)

• Objective response rate (ORR)

  2 years

• Overall survival (OS)

  2 years

• Percent of participants with adverse events (AEs)

  2 years

• Percent of participants with Grade 3-5 AEs

  2 years

• Quality of life (QOL)

  2 years

Study Arms (1)

Cabozantinib

EXPERIMENTAL

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

Interventions

Cabozantinib DRUG

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.

Also known as: XL184, Cometriq, Cabometyx, BMS907351

Cabozantinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Prior treatment with cabozantinib.
• Patients \< 18 years old.
• Patients who are pregnant or breast-feeding.
• \. 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.
• 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.

Sponsors & Collaborators

• Baptist Health South Florida: lead
• Exelixis: collaborator

Study Sites (3)

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 100653, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (19)

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Related Links

• Miami Cancer Institute

MeSH Terms

Conditions

Meningioma; Central Nervous System Neoplasms

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• Rupesh Kotecha, M.D.

  Miami Cancer Institute at Baptist Health, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupesh Kotecha, M.D.

CONTACT

(786) 596-2000; RupeshK@baptisthealth.net

Anais Vega

CONTACT

(786) 596-2000; anais.vega@baptisthealth.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)