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New treatment option for Meningioma
Official title Cabozantinib for Patients With Recurrent or Progressive Meningioma
ClinicalTrials.gov ID: NCT05425004
What this study is testing
What is Cabozantinib?
Cabozantinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for meningioma.
Also referred to as XL184, Cometriq.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Karnofsky Performance Status ≥ 50.
- Adequate hematologic function:
- Absolute Neutrophil Count ≥ 1.5 × 10\^9 / L without granulocyte colony-stimulating factor support.
You likely can't join if
- 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...
- Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of...
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) with 2 weeks before first dose of study treatment.
See the full eligibility criteria
Who can 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.
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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 people who are on a stable dose of the anticoagulant for at least 1 week before first dose of study...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- New York, New York, United States
- Nashville, Tennessee, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; New York, New York, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.