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Tyrosine Kinase Inhibitor

Cabozantinib for Pancreatic Neuroendocrine Tumors

Phase 3
Waitlist Available
Led By Jennifer A Chan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No known history of congenital long QT syndrome
No GI perforation within 6 months of registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

Study Summary

This trial compares cabozantinib to placebo in treating neuroendocrine or carcinoid tumors. Cabozantinib is a chemotherapy drug that targets specific tyrosine kinase receptors, which when blocked, may slow tumor growth.

Who is the study for?
Adults with advanced neuroendocrine or carcinoid tumors that have spread and worsened after prior therapy can join. They must be able to swallow pills, not pregnant, no severe allergies to similar drugs as cabozantinib/placebo, and have a decent performance status (able to carry out daily activities). People with certain heart conditions, uncontrolled blood pressure, recent bleeding or clotting events, or other cancers within the last 5 years cannot participate.Check my eligibility
What is being tested?
This phase III trial is testing if cabozantinib works better than a placebo for treating advanced neuroendocrine or carcinoid tumors. Cabozantinib is a chemotherapy drug that blocks specific receptors which may slow tumor growth. Patients will also undergo scans and quality-of-life assessments.See study design
What are the potential side effects?
Cabozantinib might cause high blood pressure, tiredness, mouth sores, hand-foot skin reactions, loss of appetite and weight loss. It could also lead to diarrhea or constipation and increase the risk of bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have a history of inherited long QT syndrome.
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I have not had a GI perforation in the last 6 months.
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My cancer has not spread to or around any major blood vessels.
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I am 18 years old or older.
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My condition worsened or I couldn't tolerate my previous FDA-approved treatment.
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My tumor has not invaded my digestive system, risking perforation or bleeding recently.
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I can swallow pills without any issues.
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My cancer cannot be removed by surgery and has spread.
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My cancer is a neuroendocrine tumor from the pancreas, GI tract, lung, thymus, or an unknown site.
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My cancer can be measured on a scan.
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My tumor is a well- or moderately-differentiated neuroendocrine tumor.
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I have not had severe heart failure in the last 6 months.
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I haven't had serious heart rhythm problems in the last 6 months.
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I haven't had serious stomach or intestine problems that could cause bleeding in the last 6 months.
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I haven't had any non-healing wounds or ulcers in the last 28 days.
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I do not have any active cancer except for non-melanoma skin cancer or cervical carcinoma in situ.
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I am able to get out of my bed or chair and move around.
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I am not planning to use other experimental treatments or cancer therapies while in this study.
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My kidney function is normal or only slightly reduced.
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I do not have any signs of pancreatitis.
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I have not had any fractures in the last 28 days.
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My lung cancer has not spread to the main airways or blood vessels.
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My cancer is not a high-grade neuroendocrine, adenocarcinoid, or goblet cell carcinoid tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Incidence of adverse events (AEs) graded according to the Common Terminology Criteria for Adverse Events (CTCAE) and Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Overall survival (OS)
Radiographic response rate

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%
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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (cabozantinib S-malate)Experimental Treatment5 Interventions
Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study.
Group II: Arm II (placebo)Placebo Group5 Interventions
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Cabozantinib S-malate
2013
Completed Phase 2
~470
Computed Tomography
2017
Completed Phase 2
~2720

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,708 Previous Clinical Trials
40,932,433 Total Patients Enrolled
Jennifer A ChanPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Cabozantinib S-malate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03375320 — Phase 3
Pancreatic Neuroendocrine Tumors Research Study Groups: Arm I (cabozantinib S-malate), Arm II (placebo)
Pancreatic Neuroendocrine Tumors Clinical Trial 2023: Cabozantinib S-malate Highlights & Side Effects. Trial Name: NCT03375320 — Phase 3
Cabozantinib S-malate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03375320 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most common diseases that Cabozantinib S-malate is used to manage?

"Cabozantinib S-malate is most frequently utilized as a treatment for patients who have already undergone anti-vegf therapy. Additionally, it can be effective in treating advanced renal cell carcinoma (arcc), adrenal medulla, and high risk patients."

Answered by AI

Are there other instances where Cabozantinib S-malate has been used in research?

"First investigated in 2012 at Memorial Sloan Kettering Commack, cabozantinib s-malate has had 728 completed clinical studies. As of now, there are 116 active trials underway; a large number of which are based in Decatur, Illinois."

Answered by AI

Are people with the required health qualifications still able to join this clinical trial?

"The clinical trial is still recruiting patients, according to the information on clinicaltrials.gov. This study was posted on July 18th, 2018 and updated November 4th, 2022. They are looking for 395 participants total, at 100 different sites."

Answered by AI

Does the FDA recognize Cabozantinib S-malate as an official medication?

"There is some evidence of cabozantinib s-malate's efficacy, as well as several rounds of data affirming its safety. Consequently, it received a score of 3."

Answered by AI

Is this research novel in terms of its methodology or conclusions?

"Since the first clinical trial in 2012, there have been a total of 728 studies conducted for Cabozantinib S-malate across 46 countries and 1375 cities. The initial study, sponsored by Exelixis, was completed in 2012 with 86 patients and it achieved Phase 2 drug approval."

Answered by AI

Who else is applying?

What state do they live in?
California
Nevada
How old are they?
18 - 65
What site did they apply to?
Epic Care-Dublin
OptumCare Cancer Care at Charleston
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
~45 spots leftby May 2025