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Tyrosine Kinase Inhibitor
Cabozantinib for Pheochromocytoma and Paraganglioma
Phase 2
Waitlist Available
Led By Camilo Jimenez
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Sexually active patients (men and women) must agree to use medically accepted barrier methods of contraception during the course of the study and for 4 months after the last dose of study drug(s); women of childbearing potential must have a negative pregnancy test at screening
Locally advanced or metastatic disease not amenable to surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
Study Summary
This trial studies how well cabozantinib s-malate works in treating patients with pheochromocytomas or paragangliomas that have spread. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth.
Who is the study for?
This trial is for patients with metastatic pheochromocytomas or paragangliomas that surgery can't remove. Participants must understand the study, agree to use contraception, and not be pregnant. They should have a life expectancy of at least 3 months, an ECOG status <=2, measurable disease (or bone metastases only), and no recent other cancer treatments.Check my eligibility
What is being tested?
The trial tests Cabozantinib S-malate's effectiveness on tumors that spread and can't be surgically removed. It aims to inhibit tumor growth by blocking enzymes needed for cell proliferation and new blood vessel formation necessary for tumors.See study design
What are the potential side effects?
Cabozantinib S-malate may cause side effects such as fatigue, high blood pressure, hand-foot skin reactions, gastrointestinal symptoms like diarrhea or nausea, weight loss, decreased appetite, mouth sores and abnormal liver enzyme levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use contraception during and 4 months after the study, and I (if female) have a negative pregnancy test.
Select...
My cancer cannot be removed with surgery.
Select...
My tumor is confirmed as pheochromocytoma or paraganglioma.
Select...
I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best overall response rate
Secondary outcome measures
Blood pressure control and change/discontinuation of antihypertensive medications
Incidence of adverse events (AEs)
Plasma C-reactive protein and interleukin-6
+4 moreOther outcome measures
Best overall response rate in patients with bone metastases only
Fluorodeoxyglucose -positron emission tomography/computed tomography Maximum standardized uptake value, advanced volumetric measures including peak standardized uptake value, metabolic tumor volume, and total lesion glycolysis
Incidence of skeletal related events at 4 months and one year
+2 moreSide effects data
From 2019 Phase 2 trial • 13 Patients • NCT0231543085%
Fatigue
77%
Nausea
62%
Dysgeusia
62%
Vomiting
54%
Alkaline Phosphatase Increased
54%
Aspartate Aminotransferase Increased
54%
Mucositis Oral
54%
Abdominal Pain
46%
Hypertension
46%
Anorexia
38%
Alanine Aminotransferase Increased
38%
Thromboembolic Event
38%
Anemia
38%
Diarrhea
38%
Constipation
38%
Cough
38%
Weight Loss
38%
Dyspnea
31%
Hypomagnesemia
31%
Back Pain
31%
Lipase Increased
31%
Hypoalbuminemia
23%
Hypophosphatemia
23%
Hyperglycemia
23%
Dizziness
23%
Palmar-Plantar Erythrodysesthesia Syndrome
23%
Alopecia
23%
Hypothyroidism
23%
Pain In Extremity
23%
Oral Pain
23%
Pain
23%
Headache
15%
Activated Partial Thromboplastin Time Prolonged
15%
Sore Throat
15%
Myalgia
15%
Bloating
15%
White Blood Cell Decreased
15%
Insomnia
15%
Dry Mouth
15%
Dyspepsia
15%
Dehydration
15%
Hypocalcemia
15%
Dry Skin
15%
Flushing
15%
Peripheral Sensory Neuropathy
15%
Abdominal Distension
15%
Platelet Count Decreased
8%
Generalized Muscle Weakness
8%
Allergic Rhinitis
8%
Creatinine Increased
8%
Hyponatremia
8%
Flank Pain
8%
Bone Pain
8%
Gastroesophageal Reflux Disease
8%
Chest Pain - Cardiac
8%
Vertigo
8%
Neutrophil Count Decreased
8%
Arthralgia
8%
Syncope
8%
Proteinuria
8%
Pleural Effusion
8%
Nasal Congestion
8%
Pleuritic Pain
8%
Hoarseness
8%
Nail Discoloration
8%
Ventricular Tachycardia
8%
Tinnitus
8%
Gastrointestinal Pain
8%
Floaters
8%
Dysphagia
8%
Blood Bilirubin Increased
8%
Lung Infection
8%
Fever
8%
Depression
8%
Hypersomnia
8%
Hypotension
8%
Productive Cough
8%
Memory Impairment
8%
Anxiety
8%
Cardiac Troponin I Increased
8%
Urinary Incontinence
8%
Pancreatitis
8%
Upper Respiratory Infection
8%
Bruising
8%
Weight Gain
8%
Skin Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabozantinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cabozantinib s-malate)Experimental Treatment3 Interventions
Patients receive cabozantinib s-malate PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
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?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,344 Total Patients Enrolled
15 Trials studying Paraganglioma
1,358 Patients Enrolled for Paraganglioma
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,494 Total Patients Enrolled
3 Trials studying Paraganglioma
180 Patients Enrolled for Paraganglioma
Camilo JimenezPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
1 Trials studying Paraganglioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lab test results are not within the normal range.I do not have any major ongoing health issues like heart or stomach problems.I cannot swallow pills.I am willing and able to follow the study rules and work with the research team.I agree to use contraception during and 4 months after the study, and I (if female) have a negative pregnancy test.My cancer cannot be removed with surgery.I have cancer that can be measured or is mainly in the bones.I've had a recent scan of all cancer sites within the last 28 days.You are expected to live for at least 3 more months.My tumor is confirmed as pheochromocytoma or paraganglioma.I have been treated with cabozantinib before.I haven't had certain types of radiation or experimental treatments recently.I haven't had any cancer treatments except for skin or cervical cancer in the last 2 years.Your blood and body chemistry tests need to be within certain ranges.You have a serious medical or mental health condition that, in the opinion of the doctor, would not be suitable for this study.I haven't had chemotherapy or biologic treatment recently.I am able to get out of my bed or chair and move around.My cancer has worsened in the last year according to RECIST 1.1.I understand the study requirements and have signed the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cabozantinib s-malate)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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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