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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736

95%

HYPOTHYROIDISM

73%

DIARRHEA

55%

WEIGHT LOSS

50%

FATIGUE

41%

Neutrophil Count Decreased

41%

ALANINE AMINOTRANSFERASE INCREASED

41%

ASPARTATE AMINOTRANSFERASE INCREASED

41%

VOMITING

41%

ANOREXIA

41%

NAUSEA

36%

HYPERTENSION

36%

HEADACHE

36%

PAIN IN EXTREMITY

36%

PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME

32%

PROTEINURIA

32%

PAIN

27%

White Blood Cell Count Decreased

27%

ABDOMINAL PAIN

23%

PLATELET COUNT DECREASE

23%

HYPONATREMIA

23%

Platelet Count Decreased

23%

Renal & Urinary Disorders - Other, Ketonuria

23%

Skin Hypopigmentation

23%

Decreased Platelet Count

23%

HAIR COLOR CHANGE

18%

Upper Respiratory Infection

18%

HEMOGLOBIN INCREASED

18%

HYPOKALEMIA

18%

HYPOPHOSPHATEMIA

18%

Alopecia

18%

Hyperkalemia

14%

HYPERGLYCEMIA

14%

Skin And Subcutaneous Disorders - Other, Achromotricia

14%

Pruritis

14%

HYPOGLYCEMIA

14%

Rash Maculopapular

14%

BILIRUBIN INCREASED

14%

ACNEIFORM RASH

14%

Cough

14%

Blood Bilirubin Increased

14%

DIZZINESS

14%

CONSTIPATION

14%

Rash Acneiform

14%

Fever

NASAL CONGESTION

TUMOR PAIN

Papulopustular Rash

ALKALINE PHOSPHATASE INCREASED

Creatinine Increased

Back Pain

ABSOLUTE NEUTROPHIL COUNT DECREASED

LIPASE INCREASED

Paresthesia

ORAL PAIN

LYMPHOCYTE COUNT DECREASED

Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified

WEIGHT GAIN

HYPOCALCEMIA

DRY SKIN

Periodontal Disease

Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema

Hypotension

Joint Range Of Motion Decreased

Skin And Subcutaneous Disorders - Other, Dry Skin Patches

Hypertension

SERUM AMYLASE INCREASED

Muscle Weakness Upper Limb

Investigations - Other, Eosinophilia

ANXIETY

Hypermagnesemia

Rash Ezcematoid

Behaviour Disturbance

Scalp Pain

Psychiatric Disorders - Other, Mood Swings

Sinus Tachycardia

Myalgia

Tooth Infection

JOINT RANGE OF MOTION DECREASED

Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change

Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips

URINARY FREQUENCY

Conjunctivitis

Sinusitis

Syncope

Activated Partial Thromboplastin Time Prolonged

Breast Pain

Peripheral Motor Neuropathy

Scalp Lesion

Sore Throat

Tachycardia

INSOMNIA

URINARY URGENCY

Allergic Rhinitis

Peripheral Sensory Neuropathy

HEMATURIA

RASH

Infections And Infestations - Other, Covid-19

Gastrointestinal Disorders - Other, Buccal Cyst

Investigations - Other, International Normalized Ration Increased

Infections And Infestations - Other, Gi Viral Infection

Gastrointestinal Disorders - Other, Dental Pain

Stomach Pain

SKIN INFECTION

HYPOMAGNESEMIA

Surgical & Medical Procedures - Other, Dental Extractions

Neuropathy

Investigations - Other, Increased Mean Corpuscular Volume

Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles

TENDONITIS

SINUS BRADYCARDIA

HYPERTHYROIDISM

Creatine Phosphokinase Increased

SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE

Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)

Muscle Weakness Lower Limb

Urine Discoloration

DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS

Injury, Poisoning And Procedural Complications - Other, Ankle Injury

Injury, Poisoning And Procedural Complications- Other, Scalp Laceration

Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis

Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps

Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger

Skin And Subcutaneous Tissue Disorders- Other, Erythema

SPINAL CORD COMPRESSION

ANEMIA

PARONYCHIA

BRUISING

HYPOALBUMINEMIA

Ear And Labyrinth Disorders - Other, Impacted Cerumen

Ear Pain

Elevated Amylase

Facial Pain

Gastrointestinal Disorders - Other, Stomatitis

Hoarseness

Laryngitis

Leg Pain

Localized Edema

Lung Infection

Metabolism And Nutrition Disorders - Other, Decreased Oral Intake

Metabolism Other - Decreased Vitamin D

Metbolism And Nutrition Disorders - Other, Hyperchloremia

Mucositis Oral

100%

80%

60%

40%

20%

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

0 / 15Eligibility criteria met