Cabozantinib for Meningioma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Miami Cancer Institute at Baptist Health, Inc, Miami, FL
Meningioma
Cabozantinib - Drug
Eligibility
18+
All Sexes
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Meningioma

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 5 years

2 years
Objective response rate (ORR)
Proportion of participants with adverse events
Quality of life (QOL)
5 years
Overall survival (OS)
6 months
Progression free survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Meningioma

Side Effects for

Cohort 3 - Cabozantinib for ER-, PR-, HER2-
88%Fatigue
63%Vomiting
50%Pain
38%Musculoskeletal and connective tissue disorder - Other, specify
38%Aspartate aminotransferase increased
38%Diarrhea
38%Alanine aminotransferase increased
25%Dehydration
25%Pain in extremity
25%Nausea
25%Skin and subcutaneous tissue disorders - Other, specify
25%Gastrointestinal disorders - Other, specify
25%Anorexia
25%Dysgeusia
25%Back pain
25%Cough
25%Anxiety
25%Insomnia
25%Dry skin
25%Constipation
25%Mucositis oral
13%Palmar-plantar erythrodysesthesia syndrome
13%Alkaline phosphatase increased
13%Ataxia
13%Lipase increased
13%Neck pain
13%Platelet count decreased
13%Rash maculo-papular
13%Hypertension
13%Dry mouth
13%General disorders and administration site conditions - Other, specify
13%Bruising
13%Hypomagnesemia
13%Blood bilirubin increased
13%Epistaxis
13%Headache
13%Tracheal fistula
13%Depression
13%Irregular menstruation
13%Personality change
13%Nail discoloration
13%Upper respiratory infection
13%Seizure
13%Thromboembolic event
13%Hyponatremia
13%Bloating
13%Blood and lymphatic system disorders - Other, specify
13%Gastroesophageal reflux disease
13%Endocrine disorders - Other, specify
13%Dysphasia
13%Hypothyroidism
13%Dyspepsia
13%Abdominal pain
13%Peripheral sensory neuropathy
0%Muscle weakness upper limb
0%Tracheal mucositis
0%Investigations - Other, specify
0%Hot flashes
0%Hyperglycemia
0%Infections and infestations - Other, specify
0%Skin infection
0%Generalized muscle weakness
0%Muscle weakness lower limb
0%Hearing impaired
0%Portal vein thrombosis
0%Alopecia
0%Edema limbs
0%Voice alteration
0%Rash acneiform
0%Tremor
0%Ejection fraction decreased
0%Fall
0%Paresthesia
0%Anemia
0%Cardiac disorders - Other, specify
0%Urinary urgency
0%Serum amylase increased
0%Palpitations
0%Productive cough
0%Dysmenorrhea
0%Activated partial thromboplastin time prolonged
0%Gait disturbance
0%Edema trunk
0%Vaginal infection
0%Eye infection
0%Urinary tract infection
0%Weight loss
0%Arthralgia
0%Hypoglycemia
0%Facial nerve disorder
0%Sinus pain
0%Myalgia
0%Dizziness
0%Urinary incontinence
0%Nervous system disorders - Other, specify
0%Confusion
0%Dyspnea
0%Pruritus
0%Vascular disorders - Other, specify
0%Flatulence
0%Vertigo
0%Restlessness
0%Eye disorders - Other, specify
0%Papulopustular rash
0%Presyncope
0%Dysarthria
0%Stomach pain
0%Ear pain
0%Duodenal hemorrhage
0%Dysphagia
0%Ear and labyrinth disorders - Other, specify
0%Dry eye
0%Colitis
0%Blurred vision
0%Hemorrhoids
0%Toothache
0%Pancreatitis
0%Injury, poisoning and procedural complications - Other, specify
0%Cognitive disturbance
0%Muscle weakness right-sided
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02260531) in the Cohort 3 - Cabozantinib for ER-, PR-, HER2- ARM group. Side effects include: Fatigue with 88%, Vomiting with 63%, Pain with 50%, Musculoskeletal and connective tissue disorder - Other, specify with 38%, Aspartate aminotransferase increased with 38%.

Trial Design

1 Treatment Group

Cabozantinib
1 of 1
Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Cabozantinib · No Placebo Group · Phase 2

Cabozantinib
Drug
Experimental Group · 1 Intervention: Cabozantinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2013
Completed Phase 2
~2520

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
Closest Location: Miami Cancer Institute at Baptist Health, Inc · Miami, FL
Photo of Miami 1Photo of Miami 2Photo of Miami 3
2020First Recorded Clinical Trial
1 TrialsResearching Meningioma
1 CompletedClinical Trials

Who is running the clinical trial?

ExelixisIndustry Sponsor
107 Previous Clinical Trials
17,131 Total Patients Enrolled
Baptist Health South FloridaLead Sponsor
37 Previous Clinical Trials
7,297 Total Patients Enrolled
Rupesh R KotechaPrincipal InvestigatorMiami Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have recurrent disease or progressive disease after receiving standard therapy (eg, radiation or surgery) >6 months ago or have been deemed ineligible to receive these therapies.
You have a neutrophil count of at least 1.
You are willing and able to comply with the trial protocol

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References