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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

Must not have

Unable to swallow tablets

Prior treatment with cabozantinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

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.

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.

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 below

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I agree to use contraception during and 4 months after the study, and I (if female) have a negative pregnancy test.

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My cancer cannot be removed with surgery.

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My tumor is confirmed as pheochromocytoma or paraganglioma.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow pills.

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I have been treated with cabozantinib before.

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I haven't had any cancer treatments except for skin or cervical cancer in the last 2 years.

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I haven't had chemotherapy or biologic treatment recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best overall response rate

Secondary study objectives

Blood pressure control and change/discontinuation of antihypertensive medications

Incidence of adverse events (AEs)

Plasma C-reactive protein and interleukin-6

+4 more

Other study objectives

Best overall response rate in patients with bone metastases only

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT02315430

85%

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%

Sore Throat

15%

Activated Partial Thromboplastin Time Prolonged

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

Generalized Muscle Weakness

Allergic Rhinitis

Creatinine Increased

Hyponatremia

Flank Pain

Bone Pain

Gastroesophageal Reflux Disease

Chest Pain - Cardiac

Vertigo

Neutrophil Count Decreased

Arthralgia

Syncope

Proteinuria

Pleural Effusion

Nasal Congestion

Pleuritic Pain

Hoarseness

Nail Discoloration

Ventricular Tachycardia

Tinnitus

Gastrointestinal Pain

Floaters

Dysphagia

Blood Bilirubin Increased

Lung Infection

Fever

Depression

Hypersomnia

Hypotension

Productive Cough

Memory Impairment

Anxiety

Cardiac Troponin I Increased

Urinary Incontinence

Pancreatitis

Upper Respiratory Infection

Bruising

Weight Gain

Skin Induration

100%

80%

60%

40%

20%

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

0 / 8Eligibility criteria met