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Tyrosine Kinase Inhibitor
Cabozantinib for Meningioma
Phase 2
Recruiting
Led By Rupesh R Kotecha
Research Sponsored by Baptist Health South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky Performance Status ≥ 50.
Histologic (preferred) or radiologic diagnosis of meningioma. All World Health Organization (WHO) grades (I, II and III) are allowed.
Must not have
Prior history of hypertensive encephalopathy at any time.
Concomitant anticoagulation with specific agents.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial is testing if cabozantinib, a drug typically used to treat thyroid and kidney cancers, is effective in treating meningioma, a type of brain tumor.
Who is the study for?
This trial is for adults with recurrent or progressive meningioma who have tried standard treatments over 6 months ago or can't receive them. They must be in good physical condition, with proper liver, kidney, and blood function, not pregnant or breastfeeding, willing to use contraception and follow the study plan. People under 18, with certain heart issues, infections needing IV antibiotics, uncontrolled illnesses or recent serious injuries are excluded.
What is being tested?
The trial is testing Cabozantinib's effectiveness on patients with meningioma that has come back or gotten worse after treatment. It's a Phase II study where all participants will receive Cabozantinib to see how well it works against this type of brain tumor.
What are the potential side effects?
Cabozantinib may cause side effects like high blood pressure, tiredness, loss of appetite, digestive problems such as diarrhea and nausea; hand-foot skin reactions; weight loss; new or worsening high blood pressure; bleeding problems; and slow wound healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to live my life with varying degrees of assistance.
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I have been diagnosed with meningioma, regardless of its severity.
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My blood counts meet the required levels without needing help from treatments.
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My kidneys work well enough, with a filtration rate of at least 30 ml/min.
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I am a woman who can have children and have a negative pregnancy test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never had a brain condition caused by high blood pressure.
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I am currently taking blood thinners.
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I need frequent procedures to remove excess fluid from my body.
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I need IV fluids or a feeding tube due to a blockage in my digestive system.
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I have a history of congenital QT syndrome.
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I am under 18 years old.
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I am currently on IV antibiotics for an infection.
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I have a history of unusual bleeding or clotting disorders.
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I have been treated with cabozantinib before.
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I can swallow pills and don't have issues with absorbing nutrients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival (PFS)
Secondary study objectives
Objective response rate (ORR)
Overall survival (OS)
Proportion of participants with adverse events
+1 moreSide effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Rash Acneiform
14%
Pruritis
14%
HYPOGLYCEMIA
14%
HYPERGLYCEMIA
14%
Rash Maculopapular
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
TUMOR PAIN
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
Paresthesia
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Hypotension
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Investigations - Other, Eosinophilia
5%
Sore Throat
5%
Allergic Rhinitis
5%
Muscle Weakness Lower Limb
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Behaviour Disturbance
5%
Scalp Pain
5%
Neuropathy
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Myalgia
5%
Tooth Infection
5%
RASH
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Sinusitis
5%
Syncope
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
JOINT RANGE OF MOTION DECREASED
5%
INSOMNIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
HEMATURIA
5%
Investigations - Other, International Normalized Ration Increased
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Joint Range Of Motion Decreased
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Scalp Lesion
5%
Stomach Pain
5%
TENDONITIS
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Muscle Weakness Upper Limb
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CabozantinibExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved
Find a Location
Who is running the clinical trial?
Baptist Health South FloridaLead Sponsor
52 Previous Clinical Trials
7,975 Total Patients Enrolled
ExelixisIndustry Sponsor
121 Previous Clinical Trials
20,146 Total Patients Enrolled
Rupesh R KotechaPrincipal InvestigatorMiami Cancer Institute
1 Previous Clinical Trials
269 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any major health issues that are not under control.You are allergic to cabozantinib or any ingredients in it.I am able to live my life with varying degrees of assistance.Patients must have a detectable disease according to specific criteria.Your blood clotting time is within a certain range based on the lab's normal results.I have been diagnosed with meningioma, regardless of its severity.My blood counts meet the required levels without needing help from treatments.My kidneys work well enough, with a filtration rate of at least 30 ml/min.I haven't had any cancer treatment in the last 4 weeks.I have never had a brain condition caused by high blood pressure.You have had a positive test for hepatitis C virus (HCV) or hepatitis B virus (HBV) infection.I do not have a serious wound, ulcer, or bone fracture that needed treatment in the last 28 days.I am currently taking blood thinners.I need frequent procedures to remove excess fluid from my body.I need IV fluids or a feeding tube due to a blockage in my digestive system.Your heart's electrical activity, called the QT interval, is longer than 500 milliseconds.My side effects from previous treatments are mild or being managed.I am willing and able to follow the trial's treatment plan and attend all scheduled visits.My cancer came back or got worse more than 6 months after standard treatment, or I can't have these treatments.I haven't taken any kinase inhibitor medication in the last 2 weeks.My liver is functioning within the required limits.I have a history of congenital QT syndrome.I am under 18 years old.I have not had an irregular heartbeat in the last 6 months.I am currently on IV antibiotics for an infection.Your urine has too much protein in it.I am a woman who can have children and have a negative pregnancy test.Your heart's pumping ability, measured by echocardiogram, is less than or equal to 50%. If the quality of the echocardiogram is not good enough, another test called multi-gated acquisition scan (MUGA) will be done to check your heart's pumping ability.I have a history of unusual bleeding or clotting disorders.I have been treated with cabozantinib before.I have no other cancers needing treatment besides the one being studied.I can swallow pills and don't have issues with absorbing nutrients.Your blood albumin level is 2.8 grams per deciliter or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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